Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Pain as measured by PROMIS Pain Interference Short Form 8a
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Movement to Music (Behavioral)
Outcomes
Primary Outcomes
Pain as measured by PROMIS Pain Interference Short Form 8a
Time Frame: 12 weeks
PROMIS Pain Interference Short Form 8a Questionnaire
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.
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.
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.
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
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time Frame: 12 weeks
PROMIS Fatigue Short Form 8a Questionnaire
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
Walking velocity as measured by the GaitRite
Time Frame: 12 weeks
20 meter walk is completed on the GaitRite mat
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.
Secondary Outcomes
- Health Biomarkers as measured by blood analysis (lipids)(12 weeks)
- Anthropometric measurements (BMI)(12 weeks)
- Health Biomarkers as measured by blood analysis (insulin)(12 weeks)
- Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale(12 weeks)
- Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale(12 weeks)
- Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a(12 weeks)
- Health Biomarkers as measured by blood analysis (fasting glucose)(12 weeks)
- Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)(12 weeks)
- Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b(12 weeks)
- Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a(12 weeks)
- Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a(12 weeks)
- Loneliness as measured by the Three-item loneliness scale(12 weeks)
- Body Composition as measured using a DEXA scan(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(12 weeks)
- Pain intensity is measured by the PROMIS Pain Intensity Short Form(12 weeks)
Investigators
James Rimmer
Principal Investigator
University of Alabama at Birmingham