PERFORMANCE HEALTH SYSTEMS
MEDICAL FITNESS ASSOCIATION
INNOVATIVE SOLUTIONS RESEARCH AWARD APPLICATION
The Medical Fitness Association is committed to results based programming for members of Medical Fitness Centers throughout the world. Performance Health Systems is committed to designing and manufacturing fitness and wellness performance enhancement equipment for all individuals across the entire health care continuum. In recognition of the mutual desire of these two groups to advancing results based programming in medical fitness centers throughout the world, the Medical Fitness Association is pleased to announce the 2014 Performance Health Systems (PHS) Innovative Solutions Award. The PHS Innovative Solutions Award is offered to MFA member facilities with highly educated and trained fitness professionals and program offerings focusing on a variety of health related issues and have a desire to conduct research within the medical fitness environment.
The research grant will be awarded in 2014 and will include $80,000 in equipment, assistance with research design, data collection, data analysis and assistance in writing the results in a format that would allow for submission to a major research based publication as well as making a presentation at the 2015 Medical Fitness Association Conference. There is no cash award as part of the research grant program and any additional funds required to conduct the research will be the responsibility of the awarded facility.
Applicants Must Meet The Following Requirements:
- The facility must be a Medical Fitness facility in good standing at the time of submission of application, although the facility does not necessarily need to be a certified MFA facility.
- The winning facility agrees to conduct their research using Performance Health Solutions equipment including Power Plate and bioDensity and follow the protocol submitted as part of this application.
- The winning facility agrees to modify their research scope and practice if “recommended” by the selection committee to ensure subject safety, proper use and intent of use for the exercise equipment and research time frame to insure the results can be reported at the 2015 MFA conference.
- The winning facility will allow the MFA and Performance Health Systems to use their facility name and image in all marketing materials and announcements in print and electronic format.
- The winning facility agrees to conduct the research beginning in late 2014 or early 2015 and complete all aspects of the research by September 30, 2015 allowing for results presentation at the 2015 MFA Conference.
- While the research grant is awarded to a MFA facility, the MFA facility must identify a lead researcher(s) who will be responsible for all aspects of the research process. This individual must hold a minimum of a Master’s degree in health science or exercise science with completion of at least a thesis or dissertation. This individual does not have to be an employee of the facility but the research and data collection must be conducted at the fitness facility and with members of the facility. In the event the MFA facility is interested in undertaking consideration for the research grant, but does not have access to a lead researcher, PHS can help identify a suitable candidate for the facility. However, all costs associated with obtaining and retaining the lead researcher will be the responsibility of the individual MFA facility.
- The MFA facility may partner with an outside independent medical center or university in submission of the research application and conducting the research study.
- If the MFA facility does not have a person who holds at least a Master’s degree, they may submit this application with evidence of collaboration between the medical fitness center and a hospital, university, independent research associate with the appropriate background and credentials to conduct the research study. The facility must identify what population and health or disease management category they wish to focus their research. Possible areas include but are not limited to individuals dealing with obesity, diabetes, osteoporosis, balance, mature adults, eating disorders, athletic performance enhancement and changes in behavior and mood states.
- Applicants agree to complete their research and training on the Power Plate (http://www.powerplate.com) and bioDensity (www.biodensity.com/bioDensity) which is provided as part of the research grant although other equipment may also be appropriate for training and or assessment.
Advice for Those Applying For the Performance Health Systems Innovation Research Grant
- We are not expecting applications to be submitted by Nobel award recipients. The award will go to the MFA facility that submits a clear vision of what is the problem that is being investigated, who are the subjects in the study, what is the training protocol that you think will result in change, how the subjects will be treated and protected from risks of their participation and how you will use these results to promote fitness within your facility.
- We are looking for basic research with members of medical fitness facilities and hope to grow the industry’s mission of creating and marketing programs and services that deliver results.
- The facility that is awarded the research grant will work with members of the PHS Medical Advisory Board of Advisors to fine tune their study by providing recommendations for implementation.
- When completing the research application, all questions should be made to Dr. Jason Conviser, FACSM, FMFA and the Chair of the Performance Health Systems Medical Advisory Board. He may be reached at email@example.com. Out of respect for Dr. Converser’s time, please focus your questions on specific application questions, research focus and guidelines. Please do not ask Dr. Conviser for research ideas or information on what other applicants have submitted or are planning on submitting.
- Application must be word processed. No hand written applications will be reviewed.
- Completed application form submitted electronically no later than September 30, 2014 to Rebecca Nordan at the MFA offices (firstname.lastname@example.org).
- Description of the Medical Fitness facility.
- Description of the key individual(s) employed at the Medical Fitness facility who will be responsible for all aspects of the research including publication and presentation references)
- Research summary describing the research idea and scope of investigation.
- The 2014 MFA Innovative Solutions Grant will be awarded at the 2014 MFA Congress held in November. The winning facility must be present at the time of announcement.
Description of the Medical Fitness Facility
- Name of facility
- Phone Number
- Web Site
- Number of members
- Description of medical integrated programs that are offered
- Date opened
- Name of hospital(s) associated with the facility
- Name of university(s) associated with the facility (if any)
- MFA Certified (yes or no)
- Overview of the facility mission and offerings within the facility and community
Description of the Key Researcher (s) Who Will Conduct the Research
- Position or Title in the Facility
- Attached Resume
- Educational Background including degrees, name of institution, field of study and year awarded
- Contact phone number, email
- Summary of past research experiences and where the research was reported (journal, conference, developed program etc).
Description of the Intended Research Project
- Research question – what are you interested in investigating?
- Why are you interested in investigating this topic?
- What experience do you have working with individuals dealing with this topic?
- Will you recruit facility members and / or members of the community?
- Who is your medical director AND will the medical director participate in the research study by verification in writing that all subjects meet the selection criteria for the study, are healthy to participate in the study, will be observed throughout the study to insure subject health and safety and review with the awarded facility the results of the study.
- Who are the subjects in this study and why are they appropriate to help answer the research question. For example, if you are studying obese individuals and the effects of exercise on obese individuals, subjects would need to be obese as one of the presenting criteria to participate in the study.
- What is the research design? For example, you might have a 4 group design where you have a control group (no activity), Power Plate only group, bioDensity only group and combination of Power Plate and bioDensity. (This is just one example or a research protocol).
- What is the training protocol? For example, you might begin the study with an initial assessment to determine the starting point for all subjects, training protocol such as 12 weeks of training for all exercise treatments, twice a week of Power Plate, once a week for bioDensity and three times a week for the Power Plate and bioDensity treatment groups. This training would be followed by post training assessments (this is just one possible training protocol).
- Who would not be appropriate (allowed to participate) for inclusion in this study and how will you insure this occurs? Need both inclusion and exclusion criteria
- Who are the subjects? For example, women who are between 40 – 60 years of age who have not participated in an organized weight training program for at least six months, and who have no more than two risk factors for cardiovascular disease as determined by the American College of Sports Medicine and no orthopedic injuries that would not allow the individual to participate as approved by physician WHO WISH TO INCREASE MUSCULAR CAPABILITY and BALANCE. This is just an example.
- Identify the potential risks and benefits of the study
We have attached a research application used in the past for a more sophisticated research study that has been recently approved. Significant portions of this original document have been removed or altered because the information was confidential or out of the scope of this research grant program award. You may wish to follow the flow and outline of this submission or you may ignore it completely. You may take sections from this example in their entirety and or modify sections from this example to meet your needs. The award of the PHS Grant will not “compare your submission” to this attachment – it is for your information, idea generation assistance and to help you complete this application. You may need to seek approval from a local Institutional Review Board prior to beginning this study. Consult with your researcher, hospital or university to determine the appropriate level of review.
Research Application for Work with Human Subjects Using Power Plate and bio Density Equipment
Principal Investigator(s) Medical Director Co-Investigator
The Effects of bioDensity and Power Plate Training in: Cardiovascular disease risk-reduction and fitness in Untrained Adult Males and Females
Anticipated Timeline and Duration
November 2014 (following approval) – October 31st, 2015
Objectives and Background
The overarching objectives of this study are to enroll participants in 12-week Power Plate and bioDensity exercise intervention and temporally assess:
1. risk-reduction cardiovascular risk
2. Improvement in muscular strength with short duration protocol
3. change in mood / feelings while exercising with the new treatment apparatus
Cardiovascular disease remains the number one killer of adults in North America7 with Type 2 Diabetes being a common co-morbidity. Type 2 (non-insulin dependent) diabetes, the most common form of diabetes, affects approximately 8% of the U.S. population11, roughly 24 million adult Americans2. Statistics Canada reveals that approximately 1.9 million Canadians also suffer from Type 2 Diabetes4.
Currently, primary and secondary prevention of the cardiovascular disease is focused on lifestyle/behavior change, targeting diet and exercise. The leading barrier to adopting and maintaining a physically active lifestyle is “lack of time”.12 Central to risk-reduction for cardiovascular diseases, is leading a habitually physically active lifestyle that incorporates resistance training (a.k.a. weight lifting/training) to maintain/increase lean skeletal muscle mass and strength and exert loading forces on bones that stimulate growth of new bone.
bioDensity (Figure 1) is a relatively new commercial product that functions similar to traditional resistance training equipment (Nautilus or cable-based weight lifting) but only uses four specific activities that activate multiple large and small muscle groups for each of the four activities.8 This approach differs from traditional resistance training because most Nautilus-like resistance training equipment isolates one or two muscle groups, users move from one exercise or piece of the equipment to another to exercise all major muscle groups, and can be time consuming (30-60 minutes). Current recommendations indicate that adults should perform resistance training exercises two to three times per week at a moderate intensity levels to achieve health benefits. The bioDensity approach also differs in that counter-resistance to the force being applied/produced by the user occurs from electromechanically regulated technologies (load cells measure force production in real time at the millisecond level). So users are not moving weight or resisting forces from a series of gears and pulleys. Additionally, the four bioDensity exercises are performed at a maximal contraction level for five seconds and force is exerted through a limited range of motion. The range of motion over which each of the exercises is performed is customized to each user’s body size such that the anatomical position aligns the user’s body to be in the optimal position for maximal force production. At a physiological level, this means that joint angles are predetermined and set by user body size and limb length to insure as close as possible maximal skeletal muscle cross-bridge alignment (optimized length-tension curve force production). Using the real-time electromechanical sensors and user-specific joint angle body positioning, allows users to exert maximal force many times greater than their actual body weight and do so with limited risk for musculoskeletal injury because they are in the safest anatomical position. Attempting to safely achieve these maximal levels of force production using traditional resistance training approaches (Nautilus or free-weights) would be unachievable for all but well-trained athletic populations. Moreover, inexperienced (novice) resistance trainers would not be able to achieve maximal force production without bioDensity’s anatomical alignment in safe manner. Therefore, the bioDensity approach is designed to maximize safety while providing a health-promoting neuromusculoskeletal stimulation to promote skeletal muscle growth, strength gains, and BMD improvements.
The bioDensity approach has and is being used across the country in rehabilitation, fitness, and clinical settings and the incidence of injury is reported to be low and less than that for traditional resistance training approaches.8 The health behavior change benefit of the bioDensity approach is that it takes less than 5 minutes (mean 3.1±1.0 minutes) to complete all four (near total body) resistance training exercises. This 5 minute period of time includes participant login to the bioDensity computer (secure login, password protected, known only to the participant) and set-up/positioning time on the bioDensity device performed by the technician. Additionally, because the force production is near maximal, self-regulated by the user, and significantly greater than traditional resistance training, there is greater stimulus for skeletal muscle growth and density improvements. Greater neuromuscular stimulus/recruitment is known to persists over a longer period of time (5-10 days versus lower intensity stimulation that persists for 1-3 days); therefore a bioDensity session is only performed one time each week. With respect to health-promoting changes in skeletal muscle strength and bone mineral density, minimum and maximum training thresholds vary according to the “principle of individuality”. Specifically, the minimum threshold must be greater than what the individual is already doing (i.e., baseline), and the maximum is customized to each individual based on pre-existing health status and levels that are subjectively determined by discipline experts. There are no formal algorithms or “rules” for determining maximum threshold which is why training principles are defined with the American College of Sports Medicine’s GUIDELINES for Exercise Testing and Prescription (American College of Sports Medicine, Guidelines for Exercise Testing and Prescription 9th Edition, 2012). As stated above the bioDensity approach has never been empirically validated, therefore the manufacture recommended protocol must be followed. Collectively, the time saving benefit of the bioDensity approach is 1 five minute session per week compared to 2-3 session of 30-60 minutes per week.
Recruitment efforts will target a heterogeneous sample of adults across the (1) chronic disease to healthy; (2) unfit to fit; and (3) age continuums. Participants will be recruited via fliers posted in a variety of locations throughout the club. Recruited participants will be grouped according to continuum anchors for chronic disease, fitness, and age based on baseline data collection. This grouping will allow physiological and/or health changes to the bioDensity training intervention to be compared between groups.
Participants will be: 1) males and females of any race/ethnicity; 2) 18-90 years of age; 3) cognitively capable of understanding what participation in the study entails that is assessed by comprehension questions that the participant responds to during the informed consent process; 4) free from ambulatory and/or exercise (physical activity) limitations; 5) free from uncontrolled cardiovascular disease
Interested participants will be excluded if: 1) limitations or contraindications to ambulatory and/or resistance training exercise are present; 2) acute illness or injury is present; 3) exercise or physical activity restrictions have been imposed by their health care provider; 4) female participants are of childbearing age/potential AND pregnant OR trying to become pregnant within 1-year from their recruitment date; 5) acute, uncontrolled, or complicated cardiovascular, metabolic, respiratory, or neurological conditions exist; 6) elevated blood pressure (≥140 mmHg systolic or ≥ 90 mmHg diastolic) is measured at their baseline testing session and not being controlled by medication and under the supervision of licensed health care provider; 7) the participant has experienced a stroke (hemorrhagic or thrombotic) within the past 12-months; and 8) the participant has been treated for or has a history of an aneurysm (ballooning of a blood vessel) or syncope (fainting).
“Acute, uncontrolled, or complicated” terminology is used to describe elevated patient-risk inherent with participation in physical activity or this study. The principal investigator and/or his research team will evaluate potential patients responding “Yes” to any potential exclusion criteria and determine whether exclusion is warranted or participation may be possible if authorized by a licensed medical expert. In such instances, written permission for participation from a licensed health care provider will be required (Appendix D). Participation decisions will always be conservative toward exclusion versus inclusion. General parameters to more objectively quantify “acute, uncontrolled, or complicated” will include: 1) participant reported medical diagnoses, 2) occurrence within 3-months of study initiation; 3) illness, injury, or disease that has not stabilized or been effectively treated such that participation in physical activity or exercise testing would not be approved in a medical setting; 4) contraindications to increasing physical activity persist after or during treatment/intervention; and 5) if there is no apparent health benefit to the patient associated with participating in the study. The principal investigator reserves the right to disqualify any patient or discontinue participation for any enrolled patient should he believe that a threat to the patient’s safety and/or wellbeing exists with participation in the study. In such instances, expert medical consultation (Medical Director) will be sought prior to disqualification or dis-enrollment.
Measures and intervention sequence
The measures and intervention will occur over a 12-week period of time (Table 1).
Table 1. Measure and intervention sequence
Measures and Exercise Training (estimated time for completion)
Informed consent (20 minutes)
UWHHSQ (15 minutes)
Fitness assessment (, height, weight, waist circumference) and resting blood pressure (15 minutes)
Treadmill (predicted aerobic fitness) (15 minutes)
5-component fitness assessment (vertical jump, 28-feet shuttle run, 1-minute push-up test, 1-minute sit-up test, Sit and Reach test) (15 minutes)
Maximal push-up and leg-press force production (force plate test) (15 minutes)
Weekly Power Plate and or bioDensity Training Session(s) (5 minutes per session)
However, testing sessions during these weeks will be scheduled according to participant preference and may be extended up to four separate visits to complete the testing sessions All bioDensity training sessions will occur in fitness center, and EMS personnel have toured the facility and are familiar with the locations that will be used for this study.
Description of procedures and measures
Research study explanation and informed consent (Appendix C). The research study will be described to participants in its entirety to include an active informed consent process detailing the purpose, risks, benefits, and withdrawal procedures. Patients will be asked comprehension questions such as “how many sessions will you be asked to participate in?” Correct responses will be required and material may be reviewed to insure accurate comprehension.
Height, weight, and waist circumference: These anthropometric measures will be performed
on a calibrated stadiometer and digital scale. Waist circumference will be measured using a flexible (Gulick) measuring tape according to established anatomical landmark guidelines.
Blood pressure: Blood pressure and resting heart rate will be measured in participants using standard oscillatory techniques (automated blood pressure cuff; Dynamap). Participants will rest quietly for five minutes in seated and comfortable position in a temperature controlled room. At the end of the five minute rest period blood pressure and heart rate will be measured two times separated by a two minute rest period.
Submaximal Aerobic Fitness Step Test (Queens College Step Test): Participants will be monitored using a 3-Lead ECG while completing the submaximal step test. The submaximal test will be performed in the HIP Lab or Biomechanics Lab under the supervision of the research team. The participant will step up and down on a platform (16.25” high) at a rate of 22 steps per minute for females and at 24 steps per minute for males. The participant will step using a four-step cadence, 'up-up-down-down' for 3 minutes. The participant stops immediately on completion of the test, and the heart beats are counted for 15 seconds from 5-20 seconds of recovery. This is multiplied by 4 to give the beats per minute (bpm) value to be used in the calculation below to estimate of VO2max (McArdle et al.,1972).
men: VO2max (ml/kg/min) = 111.33 - 0.42 x heart rate (bpm)
women: VO2max (ml/kg/min) = 65.81 - 0.1847 x heart rate (bpm)
5-component fitness test. The five tests that are included in this measure will be verbally explained to participants. This test is optional and participants may choose to participate in any of the five tests or not participate in any of these tests. This choice is described in the informed consent. For frail participants or participants in whom added risk/difficulty is suspected (e.g., severe osteoporosis, severe abdominal obesity, don’t think they can jump, sprint, or do push-ups or sit-ups, etc.), the research team will ask probing questions (e.g., “When was the last time you jumped, ran fast, did a push-up?” “Do you think it is safe for you to…?”) to help assess the safety of performing the different fitness tests. Participant decisions to participate or not will be honored, but the research team reserves the right to withhold the fitness tests from any participate for any or no reason. The five fitness tests will include:
Vertical Jump Test: Participants will stand comfortably on a force plate that is level with the ground. When instructed, participants will jump as high as they can reaching for the ceiling. Time from leaving the force plate to return to the force plate will be measured to calculate vertical jump height. Additionally, force and symmetry of jump take-off and jump-landing between legs will be assessed from the force plate data acquired. This test measures leg and core body power and jumping kinematics.
1-minute Sit-up Test: Participants will perform as many standard (hands behind head) or modified (arms crossed across chest) sit-ups as they can perform in 1-minute. A research assistant will secure the participants feet with their hands and body weight, and participant’s knees will be bent at 90 degrees. Participant breathing will be observed during the test with verbal feedback provided (“make sure you are breathing”). The sit-up test will be performed on a firm but forgiving 1 inch mat to provide comfort. This test measures abdominal muscle endurance.
Sit and Reach Flexibility Test: Participants will sit on the floor with their legs extended in front of them (knees straight). Participants will reach forward with both hands as far as they can and push a slide lever (approximately 4 inches above the toes) forward. The slide lever is mounted to a metal box that measures how far the participant reached. This test will be performed three times and the best (longest reach) score will be recorded. Participants will be instructed not to lunge forward but reach forward in a steady and slow motion. Participant breathing will be observed during the test with verbal feedback provided (“make sure you are breathing”). This test measures flexibility of the back and hamstrings.
Maximal Leg Press Test: On the same force plate used for the vertical jump test, participants will stand with both feet shoulder width apart. With both hands, they will hold onto an immovable bar positioned at extended finger-tip length (~ mid-thigh level). This will require participants to have slight bend in their knees, and they will be instructed to keep their back straight and shoulders pulled back. When instructed, participants will attempt to lift upwardly slowly, trying to move the bar they are holding onto. Participants will be instructed to take a deep breath prior to lifting and exhale as they lift. Participants will lift as forcefully as they can for no more than three seconds and then stop/rest. This procedure will be performed 2 times with a 2 minute rest between trials and the best score (most force produced) will be recorded from the force plate data acquisition. This test measures maximal power of the legs and back muscles.
bioDensity Resistance Training: At a schedule of the participants choice, participants will complete a single session of bioDensity training one time per week every week that they participate in the study with the exception of the baseline week The PI and his research team are experienced and familiar with the bioDensity training sessions and have repeatedly demonstrated that each session takes 5 minutes or less to complete, during which participants are only physically active for 20 seconds. Participants will perform four maximal contraction exercises lasting 5 seconds each. The four exercises are: 1) seated chest press, exercising chest, triceps, and shoulder muscles; 2) seated core pull, exercising abdominal, hip flexor, biceps, and lattisimus dorsi muscles; 3) seated leg press, exercising hip extensor, quadriceps, and calf muscles; and 4) standing vertical lift, exercising hip extensor, quadriceps, upper and lower back, shoulder, biceps, and forearm muscles. Prior to and during bioDensity training, participants will be instructed/educated on proper form, technique, and breathing to avoid and prevent injury. Every exercise session is supervised (1:1 participant to research team member ratio). Because participants are seated for three of the exercises and wearing a seatbelt, the risk of a fall injury associated with dizziness or syncope is minimized and a research team member will be guarding the patient. Guarding is a term used to describe being in a physical position to assist/hold/secure a participant to prevent injury during exercise. For the standing vertical lift research team members guard the participant within 18 inches and the participant is holding on to a handrail to also assist with balance maintenance should they become dizzy. Syncope (loss of consciousness) and dizziness associated with rapid blood pressure changes or improper breathing are the dominant physical risks that could result in a fall. We have taken precautions to screen for the likelihood of these three conditions and will assess blood pressure prior to bioDensity training sessions in participants with such risks or if they have been diagnosed with hypertension or their screening blood pressure is greater than 130 mmHg systolic or 85 mmHg diastolic. If a blood pressure is taken prior to a bioDensity training session and it is suspiciously high or low (±20 mmHg systolic or ±10 mmHg diastolic) compared to their screening blood pressure, the participant may be referred to their health care provider and the bioDensity training session will not be conducted. If participants are referred to their health care provider, they will not be able to rejoin the study and complete bioDensity training sessions until the issue has been reasonably resolved (Appendix D). If referral to a health care provider is not warranted, participants will have to reschedule their training session for that week at which time the blood pressure assessment will be repeated prior to training. All participants will receive frequent (each training/testing session) instruction on proper breathing techniques to avoid the valsalva maneuver (i.e., not holding their breath) which is the most common cause of resistance training induced dizziness and syncope.
Participants who miss more than 20 days between bioDensity training sessions will be excluded from further participation of bioDensity training. Completing at least one training session every 20 days would be enforced again for participants who opt to restart their 12-week training session. This participant exclusion stipulation is necessary to encourage/insure that participants complete at least one bioDensity training session every 20 days. Post-intervention testing on the 12-week cycle will only be conducted if participants have been compliant with missing less than 20 days between bioDensity training sessions within the 12-week timeline. High rates of non-compliance are not anticipated but this plan is included to account for it when it happens and to inform participants about the participation requirements and exclusion and repeat/re-cycle consequences (included in informed consent).
Data will be collected for the measures that participants complete at baseline at the exact time of the test. Baseline measures will then be repeated after 12-week intervention program It is a repeated measure design and data will be analyzed within groupings described previously (assuming adequate group size) by one-way repeated measures analysis of variance (RMANOVA).
The names and identifying information of participants will be kept confidential in secure locations in Corbett Building Room 208. All participant charts are stored in a locked file cabinet. Participants will be assigned a participant number and their names will be removed from all databases containing private health information. Only the principal investigator and designated research personnel will have access to the decoding list. The information gathered will only be seen by the investigative team and used for dissemination (publications/presentations) through scientific/professional organizations in a non-identifying manner. The data gathered will be stored on a private secure server in the club. Once the data is analyzed, it will be stored electronically in the possession of the principal investigator for six years. The only people who will have access to the data are the primary investigators, his research personnel, and Performance Health Systems(in cases of safety/compliance review).
The scientific value of this study to the field of health and physical activity research is significant, and the patient’s potential health changes, test results, and initiation of a physically active lifestyle are substantial tangible participant benefits provided at no cost. It is believed that the global benefits of this proposed research outweigh the risk associated with participation. Moreover, it is anticipated that the findings from this study may contribute important scientific advancements, in particular demonstrating the efficacy of a once per week 5 minute bioDensity resistance training session. Minimizing the time barrier to adopting and maintaining a resistance training exercise program could be invaluable to the primary and secondary prevention of chronic diseases moderated by improvements in lean muscle mass and bone mineral density.
Every effort has been made to maximize safety of this research study and minimize risk. However, there are risks that accompany participation in this research study:
1) Participation in any physical activity or exercise has risk. These risks include but are not limited to, pain, fainting, dizziness, fatigue, nausea, shortness of breath, chest pain (angina), heart attack, swelling, bruising, muscle/bone/joint soreness, joint damage, bone fracture, ligament/tendon/connective tissue/soft tissue damage/injury, hospitalization, and death. Both the intervention and several of the procedures/measures require participants to be physically active. Minimal risk of a heart attack during low to moderate intensity exercise is less than 1 event in over 2 million exercise hours for adults. The risk of cardiac events is higher in adults than young adults (18-24 years). The risk of sudden cardiac death during vigorous physical activity is estimated at one death per year for every 18,000 people. The risk of cardiac event or death in sedentary individuals is higher than the risk in physically active individuals. In 2010 it was estimated that even with significant growth in weight-training participation, injury incidence was ~2.3% (2.3 injuries per 100 training sessions) and 90.4% of injuries occurred with free-weights and 65.5% of injuries were related to dropping free weights. The proposed research does not include the use of free-weights so the risk of injury is expected to be low. Extrapolation of the only available weight training injury incidence data suggests that that the risk of injury when free-weights are not used is less than 1% of training sessions. All personnel are Basic Life Support certified and supervisors are ACLS certified, and necessary emergency procedures and equipment are established and available, respectively. In the event of an adverse outcome, our emergency protocols will be followed and include: 1) immediate notification of EMS; and 2) basic life support until EMS arrives. Should an adverse event occur the study will be temporarily halted until the IRB has been notified and they have advised that the study may continue.
2) During the sub-maximal step test, participants may become fatigued, tired, dizzy, or feel faint and may experience chest pain, shortness of breath, strained muscles/ligaments/tendons/joints or even bone fractures. There is a very small chance of a cardiac arrhythmia occurring (less than 1% of all adult subjects) and other rare risks such as heart attack (less than 5 in 10,000 adult cases) or death (less than 0.01% of adult cases). It is estimated that the risk of a cardiac event during exercise testing is approximately 6 events per 10,000 exercise tests. The incident rates reported are risks associated with maximal exercise stress testing. The submaximal exercise test will be administered by qualified personnel with appropriate supervision. All personnel are Basic Life Support certified and supervisors are ACLS certified, and necessary emergency procedures and equipment are established and available, respectively. In the event of an adverse outcome, our emergency protocols will be followed and include: 1) immediate notification of EMS; and 2) basic life support until EMS arrives. Should an adverse event occur the study will be temporarily halted until the IRB has been notified and they have advised that the study may continue.
4) Participants are at risk of emotional, psychological, or physical distress or discomfort if they learn that any of their health parameters are “unhealthy” or not within clinically normal ranges. Likewise, participants could experience similar distress if they screen as “high-risk” or meet exclusion criteria potentially disallowing participation. Participants screening high risk or excluded from participation may be able to participate, at the discretion of PI, if a licensed health care provider believes that the benefit of participation could be important to improving the participants health and the benefits outweigh the risks. Participants who report (to the research team) emotional or psychological distress that may be connected with participation in the research study will be referred to local counseling or psychology services/professionals for additional care. The greatest risk of abnormal or high-risk health findings is that they go undetected/undiagnosed and lead to further health complications; participation in this study may actually help detect such health risks allowing for appropriate referral for follow-up care which is a global benefit to participants in this study.
5) There is minimal risk associated with administration and completion of the questionnaire involved in this project. It is possible that participants may discover that they are at greater disease risk than they previously thought. This may cause emotional distress related to their future health. Similar referrals to professional/licensed psychological and counseling services described above will be followed if needed.
6) There is risk of an allergy or sensitivity to the latex or adhesive used in the electrodes for measuring and monitoring heart rate during the step test. We screen for adhesive and latex allergies prior to participation and use only latex-free electrodes. If skin irritation occurs we can provide topical over the counter cream to reduce the irritation; if irritation persists or is severe the participant will be referred to their health care provider.
7) As detailed above in the procedures section, steps have been taken for each of the measures/procedures to minimize risks. When feasible, safety equipment (foam pads) will be used to minimize potential for injury. The research team is well-trained in administration of the measures and bioDensity training and trained to recognize participants in whom it is inadvisable to administer any of the included measures/tests.
INFORMED CONSENT PROCEDURES
Voluntary written consent will be obtained from all participants prior to participation in the proposed study. Participants may discontinue/terminate participation in this study at any time without any penalty or loss of benefit/information to which they were previously/otherwise entitled.
MEDICAL FITNESS ASSOCIATION
2014 PHS INNOVATIVE SOLUTIONS AWARD GRANT
MAILING ADDRESS (line 1)
MAILING ADDRESS (line 2)
STATE / PROVINCE
ZIP / POSTAL CODE
DATE OF JOINING MFA (IF APPLICABLE)
(health history questionnaire)
Health History Questionnaire
HEALTH HISTORY SCREENING QUESTIONNAIRE (UWHHSQ)
Please complete thoroughly and accurately.
Date / / Place Participant Identification # Sticker Here
Address: City: State: Zip:
Date of Birth: / / Age: Phone #:
Emergency contact information: Name:________________________ Phone #: _________
Personal healthcare provider to contact in case of an emergency:
Name________________________________ Phone #: _________ City:_________________________________
CARDIOVASCULAR HEALTH HISTORY
Have you ever been diagnosed with or had any of the following?
Heart Attack? Yes No
Heart Surgery? Yes No
Cerebrovascular accident (e.g. Stroke)? Yes No
Transient Ischemic Attack (TIA)? Yes No
Carotid Artery Disease? Yes No
Cardiac Catheterization? Yes No
Coronary Angioplasty? Yes No
Pacemaker/Implantable Cardiac Device? Yes No
Irregular Heart Rate/Heart Rhythm Disturbance? Yes No
Atrial Fibrillation? Yes No
Heart Valve Disease? Yes No
Heart Failure? Yes No
Heart Murmur? Yes No
Heart Transplantation? Yes No
Aneurysm (ballooning/bulging of an artery)? Yes No
Syncope (loss of consciousness)? Yes No
Hypertension (high blood pressure)? Yes No
Congenital Heart Disease? Yes No
OTHER HEALTH HISTORY
Have you ever experienced any of the following symptoms:
Chest discomfort with exertion? Yes No
Unreasonable breathlessness (shortness of breath)? Yes No
Dizziness, fainting, or blackouts? Yes No
Syncope (loss of consciousness)? Yes No
Hypoxia (low oxygen levels)? Yes No
Do you currently take medication(s) for heart disease? Yes No
If yes, what?
Do you currently take medication(s) for high blood pressure? Yes No
If yes, what?
Have you been diagnosed with: Prediabetes Type 2 Diabetes Type 1 Diabetes
If yes, what type and for how long?______________
If yes, are you taking medication for this condition? Yes No
Have you ever experienced problems with your blood sugar levels? Yes No
If yes, please describe & include your HbA1C level if you know it
Do you have any current orthopedic (muscle, bone, joint) problems? Yes No
If yes, please describe_________________________
Do you have or have you been diagnosed with osteoporosis or osteopenia? Yes No
If yes, for how long?___________________________
If yes, are you taking medication for this condition? Yes No
Has a health care provider ever told you that you have sarcopenia Yes No
(loss of healthy skeletal muscle)?
Do you have or have you had muscle, bone or joint problems in your Yes No
hands, shoulders, arms, hips, low back, knees, or feet?
If yes, please describe
If you circled yes to any of the above statements in this section, consult your physician or other appropriate health care provider before engaging in exercise. You may need to use a facility with a medically qualified staff.
CARDIOVASCULAR RISK FACTORS
Are you a male over 45 years old? Yes No
Are you a female over 55 years old? Yes No
Have you had a hysterectomy? Yes No
Have you had both of your ovaries surgically removed? Yes No
Have you had your uterus removed? Yes No
Are you postmenopausal? Yes No
Do you currently smoke or have you quit within the last
six months? Yes No
Is your blood pressure greater than 140/90 mm Hg? Yes No
I Don’t Know
If known, what is your blood pressure? _____/ ____ mm Hg
Do you currently take blood pressure medications? Yes No
Do you currently take any medications for your heart? Yes No
Is your total blood cholesterol level greater than 200 mg/dl? Yes No I Don’t Know
Do you know your cholesterol levels? Yes No
If yes, Total Cholesterol LDL
Do you have a close blood relative who has suffered a heart attack Yes No
or had any kind of heart surgery before the age of 55 (for father
or brother) or age 65 (for mother or sister)?
Are you more than 20 pounds overweight? Yes No I Don’t Know
Are you physically inactive (i.e., do you get less than 30 minutes Yes No
of physical activity less than three times a week)?
Have you had a recent surgery (in the past 1 year)? Yes No
If yes, please explain
Have you had an exercise stress test, heart catheterization, Yes No
If yes, please explain
To the best of your knowledge, is there any reason that might Yes No
make it unsafe for you to participate in exercise?
If you circled yes to two or more of the statements in the above section you should consult your physician or other appropriate health care provider before engaging in exercise. You might benefit from using a facility with a professionally/medically qualified exercise program and staff.
To the best of my knowledge, the information I have provided above is an accurate assessment of my health and medical history.
Name of Participant Participant’s Signature Date
Name of Administering Staff Signature of Staff Member Date
Please stop here. The remainder of this Health History Screening Questionnaire will be administered to you by one of our staff.
GENERAL MEDICAL HISTORY
Height: Weight: BMI (calculated):
Do you drink alcohol? Yes No
If yes, how many drinks per week?
Are you taking any prescription or over-the-counter medication? Yes No
If yes, what medication and what dosage?
Do you take any vitamins, supplements, or
herbal/homeopathic medications? Yes No
If yes, what type and what dosage?
Has your body weight been stable over the past 6 months? Yes No
If no, please explain
Have you been on a recent diet or a prescribed diet? Yes No
If yes, please explain
Have you been diagnosed with asthma, exercise-induced asthma, reactive airway disease, chronic obstructive pulmonary disease (COPD), or any other respiratory disease? Yes No
If yes, please describe:
Do you have an allergy or skin sensitivity to latex? Yes No
Do you have an allergy or skin sensitivity to adhesives? Yes No
Have you ever been diagnosed with cancer? Yes No
If yes, please describe when and what type:
Have you ever undergone a lymphectomy? Yes No
If yes, please describe when and why?
Do you have musculoskeletal problems that limit your physical
activity such as walking? Yes No
Do you have concerns about your safety when you exercise or
exert yourself? Yes No
Have you ever experienced burning or cramping sensations in
your legs when walking short distances? Yes No
Have you ever been diagnosed with or told that you have low Yes No
blood pressure (hypotension)?
Do you know your HbA1C level (a measure blood sugar control) Yes No
If yes, what was your last level?
Do you have any other health problems, illnesses, diseases,
infections, surgeries, allergies, or hospitalizations that we should know? Yes No
If yes, please explain
Have you had an x-ray, CT scan, MRI or other x-ray like test in the past
If yes, what type of x-ray like scan have you had, how many, and when?
Please check all that apply& complete comments when necessary
Type I or II
If yes, was it before age 65?
If yes, was it before age 65?
PHYSICAL ACTIVITY HISTORY
How long have you been doing this for?
FOR FEMALES ONLY:
Are you pre- , peri- or post- menopausal?
If premenopausal, are you using any form of contraception
(birth control) or hormone therapy for any reason? Yes No
If yes, why and what type? ________________________________
If you are premenopausal:
Are you pregnant? Yes No I Don’t Know
Could you be pregnant? Yes No I Don’t Know
Are you trying to become pregnant? Yes No
If you are peri- or postmenopausal:
For how long?
When was your last menstrual period?__________________________________________
Have you had a hysterectomy w/ or w/out ovary removal? Yes No
Are you currently taking any type of hormone replacement
therapy or using any form of contraception (birth control)? Yes No
If yes, what type? How long? Dosage
Name of Administering Staff Signature of Staff Member Date
You are being invited to voluntarily participate in this research project conducted under the direction of …….
Purpose and Details of the Research.
The purpose of this study is to find out if an exercise program that uses a new type of exercise equipment helps people like you improve their health by reducing risk for heart diseases, diabetes, and osteoporosis, and improving some fitness factors like body composition, muscle strength, and bone mineral density. To do this, we will measure several disease risk factors such as your blood pressure, body composition, and fitness level before and after you complete the exercise program. The first phase of the exercise program will last 12-weeks and we will ask you to exercise on the new equipment for about 20 seconds once a week. In total, it will probably take you about 10-15 minutes to arrive at our building and come in to do your exercise program. The exercise program will include doing four exercises in which you use your muscles to exert as much force as you can. You will do each of the four exercises for 5 seconds and there will be rest between them. The four exercises are: 1) a seated chest press; 2) a seated leg press; 3) a seated bicep and stomach curl; and 4) a standing lift using your legs, back and arms to lift a bar. The health assessments and tests that you will complete are listed below. Some of these assessments and tests are optional and we may not have you complete some tests if they are too hard for you or if it might be unsafe for you. You also have the option to not participate in some of the assessments or tests if you don’t want to or don’t think it would be safe for you.
Do I qualify to participate?
You qualify for this study if:
1) you are between the ages of 18-90 years;
2) you are not pregnant or trying to become pregnant within the next 12-months;
3) you understand what participation in this study requires;
4) you are able to be physically active and have not been told by your health care provider that you
should not participate in physical activity; and
5) you have not had a stroke or been diagnosed with syncope (fainting) or an aneurysm (ballooning of
a blood vessel).
If you don’t think you qualify please tell us now. You still may be able to participate but you will need to get permission from your health care provider before you can participate.
What does my participation require?
The table below explains your participation week by week. Participation in this study will require you to meet with the research team on the University of Wyoming campus for at least 2 testing when we will collect health and fitness information from tests that you will complete. If you choose to participate from week 13-40, we will repeat your tests each time after you complete 12 weekly exercise sessions. We will schedule appointments with you at your convenience and if it is easier for you, you may spread your testing appointments out over 3-4 appointments. You will also perform your exercise sessions (1 time each week only 20 seconds of exercise) for 12 weeks or more if you decide to participate for longer. If you miss more than 20 days between your exercise sessions, we may stop your participation in the study or restart your 12 exercise sessions. We are trying to get people to do one exercise session every week but understand that things come up so we’ve provided some flexibility to you with the 20 day limit.
The health assessments, tests, exercise sessions, timeline, and your time commitment are described in the table below.
Tests, assessments & exercise sessions
(estimated time for completion)
We will give you a pedometer and instructions on how to use your pedometer and track your daily walking physical activity. (20 minutes)
We will help you complete a health history screening questionnaire – paper and pencil. (15 minutes)
Body composition and blood pressure measurement:We will measure your height, weight and blood pressure just like your health care provider does. We will also have you lie on your back on an X-ray table and the machine will measure your lean body mass, percent body fat, and bone mineral density. (15 minutes)
We will ask you to step up and down on a platform for 3 minutes and will measure your heart rate at the end of the test to determine your aerobic fitness. Your heart rate will be measured by placing 4 electrodes on your chest that are connected to a computer that measures your heart rate and rhythm. (7 minutes)
5-component fitness assessment: We will ask you to perform five fitness tests: 1) Jump as high as you can on a platform 3 times; 2) Run as fast as you can between two cones that are 28 feet apart. You will do this test 3 times; 3) We will ask you to do as many push-ups on your toes or knees as you can in 1-minute; 4) We will ask you to do as many sit-ups as you can in 1-minute; 5) We will ask you to sit on the floor with your legs extended and knees straight and then reach as far forward as you can with your hands. You will do this test 3 times. You will be able to rest between each test and participating in these tests is optional so you can choose to complete all of the tests, some of the tests, or none of the tests. (15 minutes)
Maximal push-up and leg press tests: 1) We will ask you to do 3 push-ups starting in an elbow bent position and pushing up as hard as you can. You can do the push-ups on your knees or toes; 2) In a standing position, we will ask you to hold onto an immovable bar with your hands and lift upward as forcefully as you can for 2-3 seconds. You will repeat this test 2 times. (15 minutes)
We will ask you to come to fitness center once a week when it is convenient for you to perform your weekly exercise sessions. Each exercise session will take less than 5 minutes and you only have to do this once a week, but we ask that you complete at least 12 weeks of exercise.
Your participation is voluntary.
It is important that you understand you may stop participating in the study at any time without penalty or loss of benefit to which you are otherwise entitled. To stop participating, just tell one of the research team members. Additionally it is important to remind you that if at any time during the study we think it is unsafe for you to participate, we may stop your participation or only have you participate in tests that are safe for you. You will help us determine what tests you think you can and want to do, but we will also use our expert judgment to determine if a test might be too difficult or unsafe for you.
What are your benefits if you decide to participate?
It is important that you understand that this program is not a weight loss program. Weight loss may be one of your goals and becoming more physically active can help you achieve this goal, but the program is designed to increase your muscle strength and endurance and bone mineral density. These benefits may improve some disease risk factors. . Another benefit is that your participation will help advance the scientific knowledge about whether this type of exercise program can improve the health of people who may have or be at risk for diabetes, osteoporosis, heart diseases and other chronic diseases. Your participation will help us learn about whether this exercise program could help prevent or treat several chronic diseases that people all over the world suffer from.
What are the risks if I decide to participate?
All tests and exercise sessions will be performed under the supervision of trained personnel, and all attempts will be made to minimize the minimal risks associated with your participation in this study.
1) With participation in this study, you may find out that you have certain risk factors for the development of future diseases or illnesses or that you are not as active as you thought you were. This could make you uncomfortable or distressed about your health. We will actively work with you to help alleviate any stress or emotional discomfort by referring you to the appropriate health care provider for treatment or care if needed.
2) For the exercise program, there is always the risk of injury during exercise. The risk of heart complications is low (less than 1 event in over 2 million exercise hours). Other risks include but are not limited to, pain, fainting, dizziness, fatigue, nausea, shortness of breath, chest pain or angina, swelling, bruising, muscle/bone/joint/ligament/tendon soreness, strain, sprain, bone fracture, connective tissue injury, hospitalization, and death. The risk of sudden death during vigorous physical activity is estimated at one death per year for every 18,000 people. The risk of a heart attack or death in sedentary individuals is higher than the risk in physically active individuals.
3) For the step test, you will step up and down on a platform at comfortable pace for 3 minutes. We will measure your heart rate at the end of the test using 4 sticky electrodes that will be attached to your chest with wires running to a computer. Your heart rate and blood pressure will go up during the test. With this test, you may become tired, dizzy or faint and may experience discomfort in your chest, shortness of breath, or strained muscles, ligaments, or tendons. There is a very small chance of an irregular heart beat occurring during the test (less than 1% of all tests) and other rare risks such as death (less than 0.01%). It is estimated that the risk of a heart attack during exercise testing is approximately 6 events per 10,000 exercise tests. It is important that you inform us if you have an allergy to adhesives or latex so that we can take steps to avoid problems.
4) There is a risk of breach of confidentiality. On the next page we explain how we will protect your confidentiality.
We will do our best to protect your confidentiality and your identity during the study by not allowing anyone except the authorized research team members to have access to your information. Your name will be removed from all of your information, and you will be assigned a random participant number. Only the researchers will be able to link your participant number with your name, health information, and data. The information collected will be stored on secure password protected computers and files. Paper records will be secured and in a locked file cabinet in a locked room. We will store your data for 6 years. Your data will not be used for any purposes other than the research purposes stated above. Any reporting or publication of the findings from this research will be done in a non-identifying manner. No information about your participation or health information will be released unless you direct us to share your information (written and signed authorization required). The only exception to this is if we are required by law to release your information in which case we would attempt to contact you first.
Injury and Compensation: There is no compensation available for participating in this study. The fitness center, the principal investigator, the research personnel, and our medical director are not liable for any injury you might sustain while participating in this study. The fitness center, the principal investigator, the research personnel, and our medical director are not able to offer/provide financial compensation or absorb the costs of any medical treatment should you become injured as a result of participating in this study.
If you have questions about your participation in the research study or for further information, please contact:
Identify who this is
I have read this informed consent and understand the benefits, discomforts, inconvenience, and risks associated with participation in this study. I understand that my participation is voluntary and that my refusal to participate will not involve penalty or loss of benefits to which I am otherwise entitled and that I may discontinue participation at anytime without penalty or loss of benefits to which I am otherwise entitled.
Your name, First and Last (print) _______________________________________________________
Your signature ______________________________________________________________________
Witness (print and sign): ______________________________________________________________
(Health Care Provider Authorization to Participate in bioDensity Exercise Training)
Only required and used for participants who meet exclusion criteria but in whom exercise training benefits may have health benefits that outweigh potential risks.
MEDICAL AUTHORIZATION TO PARTICIPATE IN PHYSICAL ACTIVITY
Participant/Patient Name: ___________________________ Date:_________________________
Date of Birth:__________________
Instructions for Healthcare Provider:
The person identified above is requesting your permission and authorization to participate in an exercise (physical activity) research study being conducted at the fitness center under the direction of identify the person here and his research team. After reviewing the Research Information below, please complete the bottom half of this form.
The research study will provide the participant with a health assessment that includes several chronic disease risk factors, fitness factors, These measures are being conducted to help us understand the participants risk for and/or improvement in cardiometabolic diseases (Type 2 Diabetes, Cardiovascular disease, and obesity), osteoporosis/osteopenia, and sarcopenia. These assessments will be performed before and after completion of a 12-week resistance training exercise program. The resistance training program is known as bioDensity which is new once a week time-saving approach. bioDensity is being used across the U.S. and world with low injury/complication incidence but there has been almost no empirical research conducted to validate its effectiveness. As part of this study participants will perform the bioDensity resistance training once a week for 12-36 weeks depending on participant interest. There are four total body bioDensity exercises each performed separately. Force production by participants is entirely self-induced and the equipment conforms to the participant’s optimal joint angles, limb lengths, and stature so that optimal biomechanical positioning is achieved for safe and effective resistance training. Participants perform a single 5 second contraction at maximal effort for all four exercises. Thus, the total exercise volume is only 20 seconds and there is rest between each exercise. Participants are supervised one-on-one during the exercises and instructed and reminded to breath throughout the duration of the 5 second contractions. Participants are screened for safety (hypertension, aneurysm, syncope, stroke, severe osteoporosis, orthopedic complications etc.) prior to joining the study and this is likely why you are receiving this form.
I (Health Care Provider name) give permission for the patient/participant identified above to participate in the University of Wyoming research study described above.
Health Care Provider Signature Date
Please list/describe any restrictions or additional information that you want to include:
(Content to be included in recruitment/advertising flier)
Only the content provided below will be included but the flier will be professionally produced and printed.
Recruitment/Advertising Flier Content
· Concerned about your health, osteoporosis, diabetes, or heart disease?
· Simply want to be healthier, in better shape, improve you muscular strength, tone-up your body, make your bones stronger?
· The University of Wyoming is conducting a research study.
· Young or Older, healthy or not so much à we are looking for people to participate in a research study testing the benefits of a new exercise program called bioDensity.
· bioDensity is a one-time per week exercise program that works to increase your total body muscle strength and bone mineral density.
· Improving muscle strength and bone mineral density are linked with lower risk for several chronic diseases and health improvements related in:
o Aging and the decline in muscle strength and bone strength
o Osteoporosis and osteopenia
o Several diseases of the heart and blood vessels
· You only exercise 1 time each week and perform 4 exercise targeting your entire body for 5 seconds each.
o That’s only 20 seconds of exercise each week! Can you afford the time? Can you afford to not give it a try?
· This opportunity to exercise with bioDensity will last for 12-weeks Benefits to you FREE of charge include:
o Chronic disease risk and health assessment
o Learn how active you really are in a week
o Body composition assessment – how much lean tissue do you have and what is your body fat percentage
o How aerobically fit are you
o Improve your muscle strength with very little time investment and maybe even get stronger bones.
· We are happy to work with your health care provider to make sure this exercise program is safe for you.