Cardiometabolic Risk Factors in Adult Wheelchair UsersCHIMENCT05606432
Cardiometabolic Health Intervention Using Movement-to-Music Exercise
A study testing Instructor-led, one-on-one M2M exercise group in people with Cardiometabolic Risk Factors in Adult Wheelchair Users, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music exercise program for reversing cardiometabolic health risk factors compared to asynchronous, standard exercise programs among 132 adult wheelchair users. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiometabolic Risk Factors in Adult Wheelchair Users
- What is being tested?
- Instructor-led, one-on-one M2M exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full-time or part-time use of a wheelchair device (manual wheelchair, power wheelchair, electric scooter) self-reported as the primary means of mobility
- ≥ 2 cardiometabolic risk factor(s),
- no contraindication to exercise as approved by a physician's medical clearance to exercise
- age ≥18 years
- able to use arms to exercise
- obtaining < 90 minutes of moderate-intensity aerobic exercise per week in the last month
- not enrolled in a structured exercise program in the past 6 months
- able to converse and read in English.
Who cannot join
- medically unstable to perform home exercise as determined by their physician
- high-level tetraplegia and unable to use arms to exercise
- no internet access was determined via self-report and internet speed test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama at Birmingahm
Birmingham, Alabama, 35294
Jereme Wilroy, PhD, (205) 934-0355, jdwilroy@uab.edu
Yumi Kim, PhD, 205-944-9008, yumikim@uab.edu
About this study
Official title: Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music exercise program for reversing cardiometabolic health risk factors compared to asynchronous, standard exercise programs among 132 adult wheelchair users. The targeted cardiometabolic health factors are waist circumference, triglycerides, "good" cholesterol, glucose, and blood pressure. Additionally, a 12-week follow-up phase (weeks 25-36) is included to see whether the gains are maintained.
Read the detailed description
Baseline Assessment: Participants will be asked to complete a baseline assessment. This measures physical health (e.g., cardiometabolic health factors, fat/muscle mass) and functions (e.g., muscular strength, aerobic endurance) and a series of self-reported questionnaires that are related to participant's demographics, psychosocial health (depression, sleep, fatigue), quality of life, and physical activity behaviors (volume of activity). The onsite physical tests will take approximately 2 hours to complete. The questionnaires will be completed electronically and may take up to an hour. The assessments are listed below.
PHYSICAL TEST: The physical tests will take place (1) at the UAB Research Collaborative Center (3810 Ridgeway Dr. Birmingham, AL 35209) and (2) at Lakeshore Foundation's human performance lab (4000 Ridgeway Dr. Birmingham, AL 35209).
- Blood draw
- Anthropometrics (weight, height, waist circumference)
- Body composition (amount of fat mass and fat free mass) by dual x-ray absorptiometry (DXA): DXA scans will be performed to measure any changes in fat-mass and fat-free mass. X-ray scans will be performed on 3 occasions using an iDXA whole-body scanner (GE-Lunar Radiation Corporation, Madison, WI). The radiation dose is less than 1 mrem. Scans will be analyzed using CoreScan software, and muscle mass will be estimated using published equations. Trained lab staff will be available to assist with transitioning from the wheelchair to the scan platform and back again.
- Hand grip strength: Hand-held dynamometer will be used to measure any changes in grip strength.
- Aerobic endurance by an arm-crank ergometer and open-circuit spirometry system: Open-circuit spirometry system will be used to measure any changes in heart rate, rate of perceived exertion (i.e., how much effort you feel you are giving), and amount of air you can breathe out while performing a 20-minute, continuous arm-crank ergometer.
- Lung strength by spirometer: Spirometer will be used to measure how much air you exhale and how quickly you exhale. You will take a deep breath and breathe out as hard as you can for several seconds into the tube.
QUESTIONNAIRES:
- Leisure Time Physical Activity Questionnaire for Spinal Cord Injury
- NIH PROMIS Pain Intensity Short Form
- NIH PROMIS Pain Interference Short Form
- NIH PROMIS Fatigue Short Form
- NIH PROMIS Sleep Disturbance Short Form
- NIH PROMIS 10 Global Health Items
- NIH PROMIS Ability to Participate in Social Roles and Activities
- NIH PROMIS Depression Short Form
- NIH PROMIS Anxiety Short Form
- NIH PROMIS Physical Function Form
- Exercise Self-efficacy Scale
- Exercise Goal-setting and Planning Scale
- Demographics and Health History Questionnaire
- Rapid Eating Assessment for Participants Shortened Version
Upon completing a baseline assessment, participants will be randomly assigned to one of two groups using a computer-generated code.
Group 1: Instructor-led, one-on-one exercise group (Movement-to-Music [M2M] group) Group 2: Self-guided control with pre-recorded exercise videos
Group 1: For Instructor-led, one-on-one M2M exercise group, participants will be asked to participate in 3 exercise sessions per week for 24 weeks. Each session will last from 25 minutes up to 50 minutes. Increasing by 5 to 10 minutes each week. The exercise program will focus on improving cardiorespiratory fitness using a series of movement patterns accompanied by music. The program will be tailored to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathing rate), which will be monitored through a wearable heart rate monitor and a custom-designed, secured online application with a personal username and password. All study equipment will be provided, including a computer tablet, tablet stand, and heart rate monitor.
Data collected by the application includes exercise minutes and heart rate. For the first 8 weeks (weeks 1-8), participants will exercise 3 sessions with M2M instructors or assistant health coaches. For the second 8 weeks (weeks 9-16), participants will exercise 2 sessions with M2M instructors or assistant health coaches and 1 session by himself/herself. The first sessions of each week you attend with M2M instructors will be video-recorded and later uploaded to a private cloud. The video-recorded sessions will be used when exercising with and without assistant health coaches. For the third 8 weeks (weeks 17-24), participants will exercise 1 session with assistant health coaches and 2 sessions by himself/herself.
Upon completing the 24-week program, you will receive the recorded exercise sessions between you and the M2M instructors to continue to exercise for the remaining 12 weeks (weeks 25-36).
Group 2: For self-guided control group, you will receive a tablet, tablet stand, and a series of pre-recorded exercise videos for 36 weeks. The videos include warm-up, flexibility, muscular strength, aerobic endurance, balance, and cool-down. Participants will receive a computer tablet and tablet stand.
12-week \& 24-week Follow-up Assessments: At the end of the 12- and 24-week, participants will be asked to complete the same set of physical tests and questionnaires you completed at the beginning of the study. At the end of the 36-week, participants will also be asked to complete the same questionnaires with 2 additional surveys regarding the intervention quality, which are listed below.
QUESTIONNAIRES:
- Physical Activity Enjoyment Scale 16) 5-star rating scale about M2M Instructors (M2M group only) or pre-recorded videos (Control group only)
At the end of the 12- and 24-week study period, participants will be contacted by phone for a brief interview. This interview is to gain information about participation in the program, such as positive and negative experiences. This call will be recorded for data analysis purposes. This interview process will be conducted for only 25% of participants (n=33) for the continuous program content and delivery process improvements.
- Being tested
- Instructor-led, one-on-one M2M exercise group, Self-guided control with pre-recorded standard exercise videos
- Keywords
- Cardiometabolic Risk Factors, Adult Wheelchair Users
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructor-led, one-on-one M2M exercise groupOther
Participants will attend 3 exercise sessions per week for 24 weeks. Each session will last 15 - 40 minutes. Increasing by 5 - 10 minutes each week. Each session will last from 25 to 50 minutes by increasing 5 to 10 minutes each week. The exercise program will focus on improving cardiorespiratory fitness using a series of movement patterns accompanied by music. The program will be tailored to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathing rate). For the follow-up phase (weeks 25-36), participants will receive the recorded M2M exercise sessions between the M2M instructors and themselves to continue to exercise for the remaining 12 weeks.
Self-guided control with pre-recorded standard exercise videosOther
Participants will exercise for 36 weeks using pre-recorded exercise videos. The videos include warm-up, flexibility, muscular strength, aerobic endurance, balance, and cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Instructor-led, one-on-one M2M exercise group Receives: Other: Instructor-led, one-on-one M2M exercise group |
| Group 2 | Active comparator | Self-guided control with pre-recorded standard exercise videos Receives: Other: Self-guided control with pre-recorded standard exercise videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic indicators - hsCRP
Blood test Sphygmomanometer
Measured: Baseline
Cardiometabolic indicators - HbA1C
Blood test Sphygmomanometer
Measured: Baseline
Cardiometabolic indicators - fasting insulin
Blood test SphygmomanometerSphygmomanometer
Measured: Baseline
Cardiometabolic indicators - triglycerides
Blood test Sphygmomanometer
Measured: Baseline
Cardiometabolic indicators - cholesterol
Blood test Sphygmomanometer
Measured: Baseline
Cardiometabolic indicators - glucose
Blood test Sphygmomanometer
Measured: Baseline
Cardiometabolic indicators - hsCRP
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - HbA1C
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - fasting insulin
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - triglycerides
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - cholesterol
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - glucose
Blood test Sphygmomanometer
Measured: 12 Weeks
Cardiometabolic indicators - hsCRP
Blood test Sphygmomanometer
Measured: 24 Weeks
Cardiometabolic indicators - HbA1C
Blood test Sphygmomanometer
Measured: 24 Weeks
Cardiometabolic indicators - fasting insulin
Blood test Sphygmomanometer
Measured: 24 Weeks
Cardiometabolic indicators - triglycerides
Blood test Sphygmomanometer
Measured: 24 Weeks
Cardiometabolic indicators - cholesterol
Blood test Sphygmomanometer
Measured: 24 Weeks
Body composition - DEXA
Dual energy X-ray absorptiometry
Measured: Baseline
Body composition - DEXA
Dual energy X-ray absorptiometry
Measured: 12 Weeks
Body composition - DEXA
Dual energy X-ray absorptiometry
Measured: 24 Weeks
Body composition - Waist Circumference
Measurement of waist size
Measured: Baseline
Body composition - Waist Circumference
Measurement of waist size
Measured: 12 Weeks
Body composition - Waist Circumference
Measurement of waist size
Measured: 24 Weeks
Body composition - Weight
participants weight
Measured: baseline
Body composition - Weight
participants weight
Measured: 12 weeks
Body composition - Weight
participants weight
Measured: 24 weeks
Secondary outcomes (23)
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Measured: Baseline
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Measured: 12 Weeks
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Measured: 24 Weeks
Cardiovascular capacity - Polar heart rate monitor
Polar heart rate monitor
Measured: Baseline
Cardiovascular capacity - Polar heart rate monitor
Polar heart rate monitor
Measured: 12 Weeks
Cardiovascular capacity - Polar heart rate monitor
Polar heart rate monitor
Measured: 24 Weeks
Cardiovascular capacity - Borg CR10 RPE Scale
Borg RPE Scale
Measured: Baseline
Cardiovascular capacity - Borg CR10 RPE Scale
Borg RPE Scale
Measured: 12 Weeks
Cardiovascular capacity - Borg CR10 RPE Scale
Borg RPE Scale
Measured: 24 Weeks
Pulmonary function
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Measured: Baseline
Pulmonary function
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Measured: 12 Weeks
Pulmonary function
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Measured: 24 Weeks
Muscle strength
Hand-held grip strength (kg)
Measured: Baseline
Muscle strength
Hand-held grip strength (kg)
Measured: 12 Weeks
Muscle strength
Hand-held grip strength (kg)
Measured: 24 Weeks
Physical health
Complete NIH PROMIS online surveys
Measured: Baseline
Physical health
Complete NIH PROMIS online surveys
Measured: 12 Weeks
Physical health
Complete NIH PROMIS online surveys
Measured: 24 Weeks
Physical health
Complete NIH PROMIS online surveys
Measured: 36 Weeks
Physical activity
Complete LTPAQ-SCI online survey
Measured: Baseline
Physical activity
Complete LTPAQ-SCI online survey
Measured: 12 Weeks
Physical activity
Complete LTPAQ-SCI online survey
Measured: 24 Weeks
Physical activity
Complete LTPAQ-SCI online survey
Measured: 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start11 Sep 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic Risk Factors in Adult Wheelchair UsersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jereme Wilroy, University of Alabama at Birmingham
- Investigators
- Jereme Wilroy, PhD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606432
- Sponsor's protocol ID
- IRB-300009718
- Other IDs
- 5R01HD111059
- Acronym
- CHIME
- Status last verified
- May 2026
- First submitted
- 31 Oct 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim Y, Rimmer JH, Lai B, Oster R, Cowan R, Young HJ, Fisher G, Kim Y, Giannone J, Wilroy JD. Cardiometabolic Health Intervention Using Music and Exercise (CHIME) Delivered via Telehealth to Wheelchair Users: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 15;14:e57423. doi: 10.2196/57423.
PubMed 39814364
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users
- ClinicalTrials.gov ID
- NCT05606432
- Acronym / sponsor ID
- CHIME / IRB-300009718
- Keywords
- Cardiometabolic Risk Factors, Adult Wheelchair Users
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music exercise program for reversing cardiometabolic health risk factors compared to asynchronous, standard exercise programs among 132 adult wheelchair users. The targeted cardiometabolic health factors are waist circumference, triglycerides, "good" cholesterol, glucose, and blood pressure. Additionally, a 12-week follow-up phase (weeks 25-36) is included to see whether the gains are maintained.
Detailed description
Baseline Assessment: Participants will be asked to complete a baseline assessment. This measures physical health (e.g., cardiometabolic health factors, fat/muscle mass) and functions (e.g., muscular strength, aerobic endurance) and a series of self-reported questionnaires that are related to participant's demographics, psychosocial health (depression, sleep, fatigue), quality of life, and physical activity behaviors (volume of activity). The onsite physical tests will take approximately 2 hours to complete. The questionnaires will be completed electronically and may take up to an hour. The assessments are listed below.
PHYSICAL TEST: The physical tests will take place (1) at the UAB Research Collaborative Center (3810 Ridgeway Dr. Birmingham, AL 35209) and (2) at Lakeshore Foundation's human performance lab (4000 Ridgeway Dr. Birmingham, AL 35209).
- Blood draw
- Anthropometrics (weight, height, waist circumference)
- Body composition (amount of fat mass and fat free mass) by dual x-ray absorptiometry (DXA): DXA scans will be performed to measure any changes in fat-mass and fat-free mass. X-ray scans will be performed on 3 occasions using an iDXA whole-body scanner (GE-Lunar Radiation Corporation, Madison, WI). The radiation dose is less than 1 mrem. Scans will be analyzed using CoreScan software, and muscle mass will be estimated using published equations. Trained lab staff will be available to assist with transitioning from the wheelchair to the scan platform and back again.
- Hand grip strength: Hand-held dynamometer will be used to measure any changes in grip strength.
- Aerobic endurance by an arm-crank ergometer and open-circuit spirometry system: Open-circuit spirometry system will be used to measure any changes in heart rate, rate of perceived exertion (i.e., how much effort you feel you are giving), and amount of air you can breathe out while performing a 20-minute, continuous arm-crank ergometer.
- Lung strength by spirometer: Spirometer will be used to measure how much air you exhale and how quickly you exhale. You will take a deep breath and breathe out as hard as you can for several seconds into the tube.
QUESTIONNAIRES:
- Leisure Time Physical Activity Questionnaire for Spinal Cord Injury
- NIH PROMIS Pain Intensity Short Form
- NIH PROMIS Pain Interference Short Form
- NIH PROMIS Fatigue Short Form
- NIH PROMIS Sleep Disturbance Short Form
- NIH PROMIS 10 Global Health Items
- NIH PROMIS Ability to Participate in Social Roles and Activities
- NIH PROMIS Depression Short Form
- NIH PROMIS Anxiety Short Form
- NIH PROMIS Physical Function Form
- Exercise Self-efficacy Scale
- Exercise Goal-setting and Planning Scale
- Demographics and Health History Questionnaire
- Rapid Eating Assessment for Participants Shortened Version
Upon completing a baseline assessment, participants will be randomly assigned to one of two groups using a computer-generated code.
Group 1: Instructor-led, one-on-one exercise group (Movement-to-Music [M2M] group) Group 2: Self-guided control with pre-recorded exercise videos
Group 1: For Instructor-led, one-on-one M2M exercise group, participants will be asked to participate in 3 exercise sessions per week for 24 weeks. Each session will last from 25 minutes up to 50 minutes. Increasing by 5 to 10 minutes each week. The exercise program will focus on improving cardiorespiratory fitness using a series of movement patterns accompanied by music. The program will be tailored to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathing rate), which will be monitored through a wearable heart rate monitor and a custom-designed, secured online application with a personal username and password. All study equipment will be provided, including a computer tablet, tablet stand, and heart rate monitor.
Data collected by the application includes exercise minutes and heart rate. For the first 8 weeks (weeks 1-8), participants will exercise 3 sessions with M2M instructors or assistant health coaches. For the second 8 weeks (weeks 9-16), participants will exercise 2 sessions with M2M instructors or assistant health coaches and 1 session by himself/herself. The first sessions of each week you attend with M2M instructors will be video-recorded and later uploaded to a private cloud. The video-recorded sessions will be used when exercising with and without assistant health coaches. For the third 8 weeks (weeks 17-24), participants will exercise 1 session with assistant health coaches and 2 sessions by himself/herself.
Upon completing the 24-week program, you will receive the recorded exercise sessions between you and the M2M instructors to continue to exercise for the remaining 12 weeks (weeks 25-36).
Group 2: For self-guided control group, you will receive a tablet, tablet stand, and a series of pre-recorded exercise videos for 36 weeks. The videos include warm-up, flexibility, muscular strength, aerobic endurance, balance, and cool-down. Participants will receive a computer tablet and tablet stand.
12-week \& 24-week Follow-up Assessments: At the end of the 12- and 24-week, participants will be asked to complete the same set of physical tests and questionnaires you completed at the beginning of the study. At the end of the 36-week, participants will also be asked to complete the same questionnaires with 2 additional surveys regarding the intervention quality, which are listed below.
QUESTIONNAIRES:
- Physical Activity Enjoyment Scale 16) 5-star rating scale about M2M Instructors (M2M group only) or pre-recorded videos (Control group only)
At the end of the 12- and 24-week study period, participants will be contacted by phone for a brief interview. This interview is to gain information about participation in the program, such as positive and negative experiences. This call will be recorded for data analysis purposes. This interview process will be conducted for only 25% of participants (n=33) for the continuous program content and delivery process improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Instructor-led, one-on-one M2M exercise groupInstructor-led, one-on-one M2M exercise group |
| Group 2 | Active comparator | Other: Self-guided control with pre-recorded standard exercise videosSelf-guided control with pre-recorded standard exercise videos |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- full-time or part-time use of a wheelchair device (manual wheelchair, power wheelchair, electric scooter) self-reported as the primary means of mobility
- ≥ 2 cardiometabolic risk factor(s),
- no contraindication to exercise as approved by a physician's medical clearance to exercise
- age ≥18 years
- able to use arms to exercise
Key exclusion criteria (3 listed)
- medically unstable to perform home exercise as determined by their physician
- high-level tetraplegia and unable to use arms to exercise
- no internet access was determined via self-report and internet speed test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructor-led, one-on-one M2M exercise groupParticipants will attend 3 exercise sessions per week for 24 weeks. Each session will last 15 - 40 minutes. Increasing by 5 - 10 minutes each week. Each session will last from 25 to 50 minutes by increasing 5 to 10 minutes each week. The exercise program will focus on improving cardiorespiratory fitness using a series of movement patterns accompanied by music. The program will be tailored to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathing rate). For the follow-up phase (weeks 25-36), participants will receive the recorded M2M exercise sessions between the M2M instructors and themselves to continue to exercise for the remaining 12 weeks. | Other | Group 1 |
| Self-guided control with pre-recorded standard exercise videosParticipants will exercise for 36 weeks using pre-recorded exercise videos. The videos include warm-up, flexibility, muscular strength, aerobic endurance, balance, and cool-down. | Other | Group 2 |
Primary outcome
Cardiometabolic indicators - hsCRP
Time frame: Baseline
Blood test Sphygmomanometer
Cardiometabolic indicators - HbA1C
Time frame: Baseline
Blood test Sphygmomanometer
Cardiometabolic indicators - fasting insulin
Time frame: Baseline
Blood test SphygmomanometerSphygmomanometer
Cardiometabolic indicators - triglycerides
Time frame: Baseline
Blood test Sphygmomanometer
Cardiometabolic indicators - cholesterol
Time frame: Baseline
Blood test Sphygmomanometer
Cardiometabolic indicators - glucose
Time frame: Baseline
Blood test Sphygmomanometer
Cardiometabolic indicators - hsCRP
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - HbA1C
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - fasting insulin
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - triglycerides
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - cholesterol
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - glucose
Time frame: 12 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - hsCRP
Time frame: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - HbA1C
Time frame: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - fasting insulin
Time frame: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - triglycerides
Time frame: 24 Weeks
Blood test Sphygmomanometer
Cardiometabolic indicators - cholesterol
Time frame: 24 Weeks
Blood test Sphygmomanometer
Body composition - DEXA
Time frame: Baseline
Dual energy X-ray absorptiometry
Body composition - DEXA
Time frame: 12 Weeks
Dual energy X-ray absorptiometry
Body composition - DEXA
Time frame: 24 Weeks
Dual energy X-ray absorptiometry
Body composition - Waist Circumference
Time frame: Baseline
Measurement of waist size
Body composition - Waist Circumference
Time frame: 12 Weeks
Measurement of waist size
Body composition - Waist Circumference
Time frame: 24 Weeks
Measurement of waist size
Body composition - Weight
Time frame: baseline
participants weight
Body composition - Weight
Time frame: 12 weeks
participants weight
Body composition - Weight
Time frame: 24 weeks
participants weight
23 secondary outcomes
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: Baseline
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: 12 Weeks
Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: 24 Weeks
Cardiovascular capacity - Polar heart rate monitor
Time frame: Baseline
Cardiovascular capacity - Polar heart rate monitor
Time frame: 12 Weeks
Cardiovascular capacity - Polar heart rate monitor
Time frame: 24 Weeks
Cardiovascular capacity - Borg CR10 RPE Scale
Time frame: Baseline
Cardiovascular capacity - Borg CR10 RPE Scale
Time frame: 12 Weeks
Cardiovascular capacity - Borg CR10 RPE Scale
Time frame: 24 Weeks
Pulmonary function
Time frame: Baseline
Pulmonary function
Time frame: 12 Weeks
Pulmonary function
Time frame: 24 Weeks
Muscle strength
Time frame: Baseline
Muscle strength
Time frame: 12 Weeks
Muscle strength
Time frame: 24 Weeks
Physical health
Time frame: Baseline
Physical health
Time frame: 12 Weeks
Physical health
Time frame: 24 Weeks
Physical health
Time frame: 36 Weeks
Physical activity
Time frame: Baseline
Physical activity
Time frame: 12 Weeks
Physical activity
Time frame: 24 Weeks
Physical activity
Time frame: 36 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 39814364Kim Y, Rimmer JH, Lai B, Oster R, Cowan R, Young HJ, Fisher G, Kim Y, Giannone J, Wilroy JD. Cardiometabolic Health Intervention Using Music and Exercise (CHIME) Delivered via Telehealth to Wheelchair Users: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 15;14:e57423. doi: 10.2196/57423.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jereme Wilroy, PhD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructor-led, one-on-one M2M exercise group in people with Cardiometabolic Risk Factors in Adult Wheelchair Users, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jereme Wilroy, PhD ((205) 934-0355, jdwilroy@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiometabolic indicators - hsCRP (time frame: Baseline). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.