From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings (TExT-ME)

The University of Alabama at Birmingham

Status: Completed

Conditions: Stroke; Multiple Sclerosis

Treatments: Behavioral: Movement to Music

Study type: Interventional

Funder types: Other

Identifiers

NCT03108950

F160404004

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Home-Based Movement to Music

Experimental group

Description:

The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.

Treatment:

Behavioral: Movement to Music