The University of Alabama at Birmingahm
Birmingham, Alabama, 35294, United States
Location status: Recruiting
Location contact
Jereme Wilroy, PhD
CONTACT
Jereme Wilroy, PhD
PRINCIPAL_INVESTIGATOR
Yumi Kim, PhD
CONTACT
NCT Number: NCT05606432
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.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
Location status: Recruiting
Jereme Wilroy, PhD
CONTACT
Jereme Wilroy, PhD
PRINCIPAL_INVESTIGATOR
Yumi Kim, PhD
CONTACT
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline
Blood test Sphygmomanometer
Time frame: Baseline
Blood test Sphygmomanometer
Time frame: Baseline
Blood test SphygmomanometerSphygmomanometer
Time frame: Baseline
Blood test Sphygmomanometer
Time frame: Baseline
Blood test Sphygmomanometer
Time frame: Baseline
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 12 Weeks
Blood test Sphygmomanometer
Time frame: 24 Weeks
Blood test Sphygmomanometer
Time frame: 24 Weeks
Blood test Sphygmomanometer
Time frame: 24 Weeks
Blood test Sphygmomanometer
Time frame: 24 Weeks
Blood test Sphygmomanometer
Time frame: 24 Weeks
Blood test Sphygmomanometer
Time frame: Baseline
Dual energy X-ray absorptiometry
Time frame: 12 Weeks
Dual energy X-ray absorptiometry
Time frame: 24 Weeks
Dual energy X-ray absorptiometry
Time frame: Baseline
Measurement of waist size
Time frame: 12 Weeks
Measurement of waist size
Time frame: 24 Weeks
Measurement of waist size
Time frame: baseline
participants weight
Time frame: 12 weeks
participants weight
Time frame: 24 weeks
participants weight
Time frame: Baseline
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: 12 Weeks
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: 24 Weeks
Open-circuit spirometry system (ParvoMedics TrueOne 2400)
Time frame: Baseline
Polar heart rate monitor
Time frame: 12 Weeks
Polar heart rate monitor
Time frame: 24 Weeks
Polar heart rate monitor
Time frame: Baseline
Borg RPE Scale
Time frame: 12 Weeks
Borg RPE Scale
Time frame: 24 Weeks
Borg RPE Scale
Time frame: Baseline
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Time frame: 12 Weeks
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Time frame: 24 Weeks
Spirometry (forced expiratory volume over 1 second; forced vital capacity)
Time frame: Baseline
Hand-held grip strength (kg)
Time frame: 12 Weeks
Hand-held grip strength (kg)
Time frame: 24 Weeks
Hand-held grip strength (kg)
Time frame: Baseline
Complete NIH PROMIS online surveys
Time frame: 12 Weeks
Complete NIH PROMIS online surveys
Time frame: 24 Weeks
Complete NIH PROMIS online surveys
Time frame: 36 Weeks
Complete NIH PROMIS online surveys
Time frame: Baseline
Complete LTPAQ-SCI online survey
Time frame: 12 Weeks
Complete LTPAQ-SCI online survey
Time frame: 24 Weeks
Complete LTPAQ-SCI online survey
Time frame: 36 Weeks
Complete LTPAQ-SCI online survey
Contact information is provided by the study sponsor or research team.
Jereme Wilroy, PhD
CONTACT
Yumi Kim, PhD
CONTACT
University of Alabama at Birmingham
Other
Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users
Acronym: CHIME
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.