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

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.

Official Title
-----------------
Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis

Conditions
-----------------
Stroke, Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Movement to Music


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-Based Movement to Music<br>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. | Behavioral: Movement to Music<br>* 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.<br>* Other names: M2M;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory Fitness as measured by sub-maximal VO2 | 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 | 12 weeks | 
| Pain as measured by PROMIS Pain Interference Short Form 8a | PROMIS Pain Interference Short Form 8a Questionnaire | 12 weeks | 
| Fatigue as measured by PROMIS Fatigue Short Form 8a | PROMIS Fatigue Short Form 8a Questionnaire | 12 weeks | 
| Grip Strength as measured by hand grip dynamometer | Participants exert as much force as possible using a Jamar hand grip dynamometer | 12 weeks | 
| Strength as measured by Biodex System 3 Multijoint dynamometer | Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol. | 12 weeks | 
| Balance as measured by the Timed Up and Go | 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 | The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex. | 12 weeks | 
| Balance as measured by Repeated Chair Stands | 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. | 12 weeks | 
| Walking velocity as measured by the GaitRite | 20 meter walk is completed on the GaitRite mat | 12 weeks | 

Secondary Outcome Measures

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