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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD111059 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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).
QUESTIONNAIRES:
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:
15) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Instructor-led, one-on-one M2M exercise group |
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| Group 2 | Active Comparator | Self-guided control with pre-recorded standard exercise videos |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instructor-led, one-on-one M2M exercise group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | Baseline |
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | Baseline |
| Cardiometabolic indicators - fasting insulin | Blood test SphygmomanometerSphygmomanometer | Baseline |
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | Baseline |
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | Baseline |
| Cardiometabolic indicators - glucose | Blood test Sphygmomanometer | Baseline |
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | 12 Weeks |
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | 12 Weeks |
| Cardiometabolic indicators - fasting insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Baseline |
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jereme Wilroy, PhD | Contact | (205) 934-0355 | jdwilroy@uab.edu | |
| Yumi Kim, PhD | Contact | 205-944-9008 | yumikim@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jereme Wilroy, PhD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingahm | Recruiting | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39814364 | Derived | 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. |
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This is a single-blinded study that conceals the group allocation from physical outcome assessors.
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| Self-guided control with pre-recorded standard exercise videos | Other | 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. |
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Blood test Sphygmomanometer
| 12 Weeks |
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | 12 Weeks |
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | 12 Weeks |
| Cardiometabolic indicators - glucose | Blood test Sphygmomanometer | 12 Weeks |
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | 24 Weeks |
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | 24 Weeks |
| Cardiometabolic indicators - fasting insulin | Blood test Sphygmomanometer | 24 Weeks |
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | 24 Weeks |
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | 24 Weeks |
| Body composition - DEXA | Dual energy X-ray absorptiometry | Baseline |
| Body composition - DEXA | Dual energy X-ray absorptiometry | 12 Weeks |
| Body composition - DEXA | Dual energy X-ray absorptiometry | 24 Weeks |
| Body composition - Waist Circumference | Measurement of waist size | Baseline |
| Body composition - Waist Circumference | Measurement of waist size | 12 Weeks |
| Body composition - Waist Circumference | Measurement of waist size | 24 Weeks |
| Body composition - Weight | participants weight | baseline |
| Body composition - Weight | participants weight | 12 weeks |
| Body composition - Weight | participants weight | 24 weeks |
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
| 12 Weeks |
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Open-circuit spirometry system (ParvoMedics TrueOne 2400) | 24 Weeks |
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | Baseline |
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | 12 Weeks |
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | 24 Weeks |
| Cardiovascular capacity - Borg CR10 RPE Scale | Borg RPE Scale | Baseline |
| Cardiovascular capacity - Borg CR10 RPE Scale | Borg RPE Scale | 12 Weeks |
| Cardiovascular capacity - Borg CR10 RPE Scale | Borg RPE Scale | 24 Weeks |
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | Baseline |
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | 12 Weeks |
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | 24 Weeks |
| Muscle strength | Hand-held grip strength (kg) | Baseline |
| Muscle strength | Hand-held grip strength (kg) | 12 Weeks |
| Muscle strength | Hand-held grip strength (kg) | 24 Weeks |
| Physical health | Complete NIH PROMIS online surveys | Baseline |
| Physical health | Complete NIH PROMIS online surveys | 12 Weeks |
| Physical health | Complete NIH PROMIS online surveys | 24 Weeks |
| Physical health | Complete NIH PROMIS online surveys | 36 Weeks |
| Physical activity | Complete LTPAQ-SCI online survey | Baseline |
| Physical activity | Complete LTPAQ-SCI online survey | 12 Weeks |
| Physical activity | Complete LTPAQ-SCI online survey | 24 Weeks |
| Physical activity | Complete LTPAQ-SCI online survey | 36 Weeks |