- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108950
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings (TExT-ME)
Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35209
- Lakeshore Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home-Based 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiorespiratory Fitness as measured by sub-maximal VO2
Time Frame: 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
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12 weeks
|
Strength as measured by Biodex System 3 Multijoint dynamometer
Time Frame: 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.
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12 weeks
|
Balance as measured by the Timed Up and Go
Time Frame: 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.
|
12 weeks
|
Balance as measured by Biodex Limits of Stability
Time Frame: 12 weeks
|
The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
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12 weeks
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Balance as measured by Repeated Chair Stands
Time Frame: 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.
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12 weeks
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Pain as measured by PROMIS Pain Interference Short Form 8a
Time Frame: 12 weeks
|
PROMIS Pain Interference Short Form 8a Questionnaire
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12 weeks
|
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time Frame: 12 weeks
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PROMIS Fatigue Short Form 8a Questionnaire
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12 weeks
|
Grip Strength as measured by hand grip dynamometer
Time Frame: 12 weeks
|
Participants exert as much force as possible using a Jamar hand grip dynamometer
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12 weeks
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Walking velocity as measured by the GaitRite
Time Frame: 12 weeks
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20 meter walk is completed on the GaitRite mat
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Biomarkers as measured by blood analysis (insulin)
Time Frame: 12 weeks
|
Participants undergo a fasted blood draw to assess insulin
|
12 weeks
|
Health Biomarkers as measured by blood analysis (lipids)
Time Frame: 12 weeks
|
Participants undergo a fasted blood draw to assess lipids
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12 weeks
|
Health Biomarkers as measured by blood analysis (fasting glucose)
Time Frame: 12 weeks
|
Participants undergo a fasted blood draw to assess glucose
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12 weeks
|
Anthropometric measurements (BMI)
Time Frame: 12 weeks
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height and weight are assessed to compute BMI
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12 weeks
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Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Time Frame: 12 weeks
|
circumference measures are completed at the neck, hip, and waist.
Waist to hip ratios are computed (A/G ratio)
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12 weeks
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Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Time Frame: 12 weeks
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PROMIS Physical Function with Mobility Aid 455b questionnaire
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12 weeks
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Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Time Frame: 12 weeks
|
PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire
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12 weeks
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Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Time Frame: 12 weeks
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PROMIS Emotional Distress-Depression Short Form 8a questionnaire
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12 weeks
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Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Time Frame: 12 weeks
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PROMIS Sleep Disturbance Short Form 8a questionnaire
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12 weeks
|
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Time Frame: 12 weeks
|
PROMIS Ability to Participate in Social Roles and Activities Short Form 8a questionnaire
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12 weeks
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Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Time Frame: 12 weeks
|
Nutrition Self-Efficacy Scale
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12 weeks
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Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Time Frame: 12 weeks
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Physical Exercise Self Efficacy Scale
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12 weeks
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Pain intensity is measured by the PROMIS Pain Intensity Short Form
Time Frame: 12 weeks
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PROMIS Pain Intensity Short Form questionnaire
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12 weeks
|
Body Composition as measured using a DEXA scan
Time Frame: 12 weeks
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GE Lunar Dual X-ray Absorptiometry is used to assess total body composition
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12 weeks
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Loneliness as measured by the Three-item loneliness scale
Time Frame: 12 weeks
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Three item loneliness scale
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12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James Rimmer, PhD, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F160404004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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