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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Stroke
• Interventions: Behavioral: Movement to Music

• Registration Number: NCT03108950
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-Based Movement to Music	Movement to Music	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.

Primary Outcome Measures

Name	Time	Method
Pain as measured by PROMIS Pain Interference Short Form 8a	12 weeks	PROMIS Pain Interference Short Form 8a Questionnaire
Balance as measured by the Timed Up and Go	12 weeks	The Timed to Up and Go test is performed using a chair with arms. The participants stand up from the chair, walk to a mark measured three meters from the chair then return back to the seat. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
Balance as measured by Biodex Limits of Stability	12 weeks	The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
Balance as measured by Repeated Chair Stands	12 weeks	The repeated chair stands test is performed by asking participants to stand up and sit down 5 times as fast as possible. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
Cardiorespiratory Fitness as measured by sub-maximal VO2	12 weeks	Submax VO2 is assessed by the six minute walk test or the six minute push test. Participants wear a portable metabolic cart while walking or pushing
Fatigue as measured by PROMIS Fatigue Short Form 8a	12 weeks	PROMIS Fatigue Short Form 8a Questionnaire
Grip Strength as measured by hand grip dynamometer	12 weeks	Participants exert as much force as possible using a Jamar hand grip dynamometer
Walking velocity as measured by the GaitRite	12 weeks	20 meter walk is completed on the GaitRite mat
Strength as measured by Biodex System 3 Multijoint dynamometer	12 weeks	Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.

Secondary Outcome Measures

Name	Time	Method
Health Biomarkers as measured by blood analysis (lipids)	12 weeks	Participants undergo a fasted blood draw to assess lipids
Anthropometric measurements (BMI)	12 weeks	height and weight are assessed to compute BMI
Health Biomarkers as measured by blood analysis (insulin)	12 weeks	Participants undergo a fasted blood draw to assess insulin
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale	12 weeks	Nutrition Self-Efficacy Scale
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale	12 weeks	Physical Exercise Self Efficacy Scale
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a	12 weeks	PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire
Health Biomarkers as measured by blood analysis (fasting glucose)	12 weeks	Participants undergo a fasted blood draw to assess glucose
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)	12 weeks	circumference measures are completed at the neck, hip, and waist. Waist to hip ratios are computed (A/G ratio)
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b	12 weeks	PROMIS Physical Function with Mobility Aid 455b questionnaire
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a	12 weeks	PROMIS Sleep Disturbance Short Form 8a questionnaire
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a	12 weeks	PROMIS Emotional Distress-Depression Short Form 8a questionnaire
Loneliness as measured by the Three-item loneliness scale	12 weeks	Three item loneliness scale
Body Composition as measured using a DEXA scan	12 weeks	GE Lunar Dual X-ray Absorptiometry is used to assess total body composition
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a	12 weeks	PROMIS Ability to Participate in Social Roles and Activities Short Form 8a questionnaire
Pain intensity is measured by the PROMIS Pain Intensity Short Form	12 weeks	PROMIS Pain Intensity Short Form questionnaire

Trial Locations

Locations (1)

Lakeshore Foundation; 🇺🇸 Birmingham, Alabama, United States