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.

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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.

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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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

27

Study ID:

NCT03108950

Recruitment Status:

Completed

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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Lakeshore Foundation
Birmingham Alabama, 35209, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

27

Study ID:

NCT03108950

Recruitment Status:

Completed

Sponsor:


University of Alabama at Birmingham

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