Recruiting

Movement-to-Music

Sponsor:

University of Alabama at Birmingham

Code:

NCT05606432

Conditions

Cardiometabolic Risk Factors in Adult Wheelchair Users

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Instructor-led, one-on-one M2M exercise group

Self-guided control with pre-recorded standard exercise videos

Study Details

Brief 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. 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.

Conditions

Cardiometabolic Risk Factors in Adult Wheelchair Users

Study ID

NCT05606432

Start date

Sep 11, 2023

Status verified date

May, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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. ≥ 2 cardiometabolic risk factor(s),
3. no contraindication to exercise as approved by a physician's medical clearance to exercise
4. age ≥18 years
5. able to use arms to exercise
6. obtaining < 90 minutes of moderate-intensity aerobic exercise per week in the last month
7. not enrolled in a structured exercise program in the past 6 months
8. able to converse and read in English.

Exclusion Criteria:

1. medically unstable to perform home exercise as determined by their physician
2. high-level tetraplegia and unable to use arms to exercise
3. no internet access was determined via self-report and internet speed test.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Instructor-led, one-on-one M2M exercise group

active comparator: Group 2

Self-guided control with pre-recorded standard exercise videos

Interventions

Instructor-led, one-on-one M2M exercise group

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 videos

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.

Primary outcome measure

  • Cardiometabolic indicators - hsCRP [ Time Frame: Baseline ]
  • Cardiometabolic indicators - HbA1C [ Time Frame: Baseline ]
  • Cardiometabolic indicators - fasting insulin [ Time Frame: Baseline ]
  • Cardiometabolic indicators - triglycerides [ Time Frame: Baseline ]
  • Cardiometabolic indicators - cholesterol [ Time Frame: Baseline ]
  • Cardiometabolic indicators - glucose [ Time Frame: Baseline ]
  • Cardiometabolic indicators - hsCRP [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - HbA1C [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - fasting insulin [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - triglycerides [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - cholesterol [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - glucose [ Time Frame: 12 Weeks ]
  • Cardiometabolic indicators - hsCRP [ Time Frame: 24 Weeks ]
  • Cardiometabolic indicators - HbA1C [ Time Frame: 24 Weeks ]
  • Cardiometabolic indicators - fasting insulin [ Time Frame: 24 Weeks ]
  • Cardiometabolic indicators - triglycerides [ Time Frame: 24 Weeks ]
  • Cardiometabolic indicators - cholesterol [ Time Frame: 24 Weeks ]
  • Body composition - DEXA [ Time Frame: Baseline ]
  • Body composition - DEXA [ Time Frame: 12 Weeks ]
  • Body composition - DEXA [ Time Frame: 24 Weeks ]
  • Body composition - Waist Circumference [ Time Frame: Baseline ]
  • Body composition - Waist Circumference [ Time Frame: 12 Weeks ]
  • Body composition - Waist Circumference [ Time Frame: 24 Weeks ]
  • Body composition - Weight [ Time Frame: baseline ]
  • Body composition - Weight [ Time Frame: 12 weeks ]
  • Body composition - Weight [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

The University of Alabama at Birmingahm

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Jereme Wilroy, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Cardiometabolic Risk Factors
  • Adult Wheelchair Users

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-08.