NCT03797378Completed
Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study
The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested. \*\*In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.\*\*
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 13 Nov 2018
- Start date
- 9 Aug 2019
- Primary completion date
- 25 May 2023
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Stroke, Parkinson disease, Multiple sclerosis
- NCT number
- NCT03797378
What you commit to
- Study type: Interventional
- Participants enrolled: 108
- From 9 Aug 2019 to the primary completion date, 25 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current smoker or recently quit less than 6 months prior
Other illness
- Cognitive impairment (Folstein's Mini-Mental State Exam score \<24)
- Presence of active pressure ulcer
- Significant hearing impairment impeding ability to hear music to engage in exercise
Other
- Participate in an exercise intervention or a similar intervention in the last 6 months
- Any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines
- Visual acuity that prevents following a group exercise class
Who the study is looking for
- Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician
- Able to use upper limbs and/or lower limbs to exercise and follow instructions
- Physician clearance to participate
- Willing to participate in an exercise program three times per week
- Conversant in and reads English
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAB Research Collaborative Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.