Multiple Sclerosis Clinical Trial
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Diagnosed with stroke
MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
Able to use arms or arm/legs for exercise
Ambulatory or use manual wheelchair
Exclusion Criteria:
Cognitive impairment (Mini-Mental State Exam score < 24)
Recent weight change (+/- 25 pounds in 1 year)
Poorly controlled blood pressure
Cardiovascular disease event within the past six months
Severe pulmonary disease
Renal failure
Current tobacco user or quit within the last six months
Current use of medications for psychosis
Active pressure ulcers
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Birmingham Alabama, 35209, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.