Stroke Clinical Trial
Official title:
Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
The specific aim of the study in our example is to conduct a feasibility translational home-based exercise trial established in the LEADERS (R2) project with the TExt-ME tele-exercise training system for participants with neurologic disability. We hypothesize that participants in this home-based tele-exercise training program will achieve similar gains in health and function outcomes as the onsite exercise training program. Further, there will be no difference in adverse side effects (safety) between the home-based and onsite exercise treatment groups.
TExT-ME is a home-based tele-exercise study providing a novel exercise program to
participants with neurologic disabilities. The exercise curriculum is a Movement 2 Music
(M2M) program developed during phase 2 of the grant (clinicaltrials.gov identifier
NCT02533882). The exercise exercise classes are taught by trained dance instructors and are
composed of a set of exercises tailored to the specific needs and capabilities of adults with
neurologic disability. Each set of exercises is performed to high and low tempo music based
on the individual's baseline level of function, with adjustments made to increase or decrease
intensity if needed. The class consists of several training components: a) warmup (10 min.)
to increase range of motion; strength/balance (15-20 min), aerobics (25-30 min. with rest
periods as necessary); cool down (5 min).
The TExT-ME training and monitoring system is a user-centered design (UCD) involving a
tele-exercise coach (e.g., a trained research staff person) interacting remotely with a
participant in their home using video conferencing programs. Participants wear monitors to
maintain safe levels of exercise and provide feedback regarding exercise intensity to the
instructors. Self-reported indicators of exercise intensity are also collected using rating
of perceived exertion.
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