The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)

CompletedNot a drug-phase studyMS (type not specified)NCT03797378

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • eM2M

What it measured

Main measures

  • Change from baseline cardiorespiratory fitness at 3 months

    Baseline and post 12-week intervention

    Physical function
  • Change from baseline muscle strength at 3 months

    Baseline and post 12-week intervention

    Arm and hand functionPhysical function

Other measures (4)

  • Change from baseline lower extremity function at 3 months

    Baseline and post 12-week intervention

    Walking and mobility
  • Change from baseline health-related quality of life at 3 months

    Baseline and post 12-week intervention

    Quality of life (reported by participants)
  • Change from baseline social participation at 3 months

    Baseline and post 12-week intervention

    Quality of life (reported by participants)
  • Change from baseline physical activity at 3 months

    Baseline and post 12-week intervention

    Physical function

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* 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

Exclusion criteria

* Participate in an exercise intervention or a similar intervention in the last 6 months * Current smoker or recently quit less than 6 months prior * Cognitive impairment (Folstein's Mini-Mental State Exam score \<24) * Presence of active pressure ulcer * Any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines * Visual acuity that prevents following a group exercise class * Significant hearing impairment impeding ability to hear music to engage in exercise

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.**

Papers

Loading reviews and guidelines…

History

    1. Started

      Aug 2019

    2. Main results due

      May 2023

    3. Finished

      Sept 2025

    Assembled by software from public sources.