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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Jereme Wilroy, PhD contact

(205) 934-0355

jdwilroy@uab.edu

Yumi Kim, PhD contact

205-944-9008

yumikim@uab.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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).

  1. Blood draw
  2. Anthropometrics (weight, height, waist circumference)
  3. 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.
  4. Hand grip strength: Hand-held dynamometer will be used to measure any changes in grip strength.
  5. 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.
  6. 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:

  1. Leisure Time Physical Activity Questionnaire for Spinal Cord Injury
  2. NIH PROMIS Pain Intensity Short Form
  3. NIH PROMIS Pain Interference Short Form
  4. NIH PROMIS Fatigue Short Form
  5. NIH PROMIS Sleep Disturbance Short Form
  6. NIH PROMIS 10 Global Health Items
  7. NIH PROMIS Ability to Participate in Social Roles and Activities
  8. NIH PROMIS Depression Short Form
  9. NIH PROMIS Anxiety Short Form
  10. NIH PROMIS Physical Function Form
  11. Exercise Self-efficacy Scale
  12. Exercise Goal-setting and Planning Scale
  13. Demographics and Health History Questionnaire
  14. 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:

  1. 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 groups in NCT05606432
Study groupRoleWhat they receive
Group 1ExperimentalInstructor-led, one-on-one M2M exercise group
Receives: Other: Instructor-led, one-on-one M2M exercise group
Group 2Active comparatorSelf-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.

  1. Cardiometabolic indicators - hsCRP

    Blood test Sphygmomanometer

    Measured: Baseline

  2. Cardiometabolic indicators - HbA1C

    Blood test Sphygmomanometer

    Measured: Baseline

  3. Cardiometabolic indicators - fasting insulin

    Blood test SphygmomanometerSphygmomanometer

    Measured: Baseline

  4. Cardiometabolic indicators - triglycerides

    Blood test Sphygmomanometer

    Measured: Baseline

  5. Cardiometabolic indicators - cholesterol

    Blood test Sphygmomanometer

    Measured: Baseline

  6. Cardiometabolic indicators - glucose

    Blood test Sphygmomanometer

    Measured: Baseline

  7. Cardiometabolic indicators - hsCRP

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  8. Cardiometabolic indicators - HbA1C

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  9. Cardiometabolic indicators - fasting insulin

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  10. Cardiometabolic indicators - triglycerides

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  11. Cardiometabolic indicators - cholesterol

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  12. Cardiometabolic indicators - glucose

    Blood test Sphygmomanometer

    Measured: 12 Weeks

  13. Cardiometabolic indicators - hsCRP

    Blood test Sphygmomanometer

    Measured: 24 Weeks

  14. Cardiometabolic indicators - HbA1C

    Blood test Sphygmomanometer

    Measured: 24 Weeks

  15. Cardiometabolic indicators - fasting insulin

    Blood test Sphygmomanometer

    Measured: 24 Weeks

  16. Cardiometabolic indicators - triglycerides

    Blood test Sphygmomanometer

    Measured: 24 Weeks

  17. Cardiometabolic indicators - cholesterol

    Blood test Sphygmomanometer

    Measured: 24 Weeks

  18. Body composition - DEXA

    Dual energy X-ray absorptiometry

    Measured: Baseline

  19. Body composition - DEXA

    Dual energy X-ray absorptiometry

    Measured: 12 Weeks

  20. Body composition - DEXA

    Dual energy X-ray absorptiometry

    Measured: 24 Weeks

  21. Body composition - Waist Circumference

    Measurement of waist size

    Measured: Baseline

  22. Body composition - Waist Circumference

    Measurement of waist size

    Measured: 12 Weeks

  23. Body composition - Waist Circumference

    Measurement of waist size

    Measured: 24 Weeks

  24. Body composition - Weight

    participants weight

    Measured: baseline

  25. Body composition - Weight

    participants weight

    Measured: 12 weeks

  26. Body composition - Weight

    participants weight

    Measured: 24 weeks

Secondary outcomes (23)
  1. Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Measured: Baseline

  2. Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Measured: 12 Weeks

  3. Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Open-circuit spirometry system (ParvoMedics TrueOne 2400)

    Measured: 24 Weeks

  4. Cardiovascular capacity - Polar heart rate monitor

    Polar heart rate monitor

    Measured: Baseline

  5. Cardiovascular capacity - Polar heart rate monitor

    Polar heart rate monitor

    Measured: 12 Weeks

  6. Cardiovascular capacity - Polar heart rate monitor

    Polar heart rate monitor

    Measured: 24 Weeks

  7. Cardiovascular capacity - Borg CR10 RPE Scale

    Borg RPE Scale

    Measured: Baseline

  8. Cardiovascular capacity - Borg CR10 RPE Scale

    Borg RPE Scale

    Measured: 12 Weeks

  9. Cardiovascular capacity - Borg CR10 RPE Scale

    Borg RPE Scale

    Measured: 24 Weeks

  10. Pulmonary function

    Spirometry (forced expiratory volume over 1 second; forced vital capacity)

    Measured: Baseline

  11. Pulmonary function

    Spirometry (forced expiratory volume over 1 second; forced vital capacity)

    Measured: 12 Weeks

  12. Pulmonary function

    Spirometry (forced expiratory volume over 1 second; forced vital capacity)

    Measured: 24 Weeks

  13. Muscle strength

    Hand-held grip strength (kg)

    Measured: Baseline

  14. Muscle strength

    Hand-held grip strength (kg)

    Measured: 12 Weeks

  15. Muscle strength

    Hand-held grip strength (kg)

    Measured: 24 Weeks

  16. Physical health

    Complete NIH PROMIS online surveys

    Measured: Baseline

  17. Physical health

    Complete NIH PROMIS online surveys

    Measured: 12 Weeks

  18. Physical health

    Complete NIH PROMIS online surveys

    Measured: 24 Weeks

  19. Physical health

    Complete NIH PROMIS online surveys

    Measured: 36 Weeks

  20. Physical activity

    Complete LTPAQ-SCI online survey

    Measured: Baseline

  21. Physical activity

    Complete LTPAQ-SCI online survey

    Measured: 12 Weeks

  22. Physical activity

    Complete LTPAQ-SCI online survey

    Measured: 24 Weeks

  23. 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.

  1. First posted4 Nov 2022
  2. Study start11 Sep 2023
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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)
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

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.

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