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.
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.
- Movement to Music Behavioral
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Home-Based Movement to Music 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.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Cardiorespiratory Fitness as measured by sub-maximal VO2||12 weeks|
|Primary||Pain as measured by PROMIS Pain Interference Short Form 8a||12 weeks|
|Primary||Fatigue as measured by PROMIS Fatigue Short Form 8a||12 weeks|
|Primary||Grip Strength as measured by hand grip dynamometer||12 weeks|
|Primary||Strength as measured by Biodex System 3 Multijoint dynamometer||12 weeks|
|Primary||Balance as measured by the Timed Up and Go||12 weeks|
|Primary||Balance as measured by Biodex Limits of Stability||12 weeks|
|Primary||Balance as measured by Repeated Chair Stands||12 weeks|
|Primary||Walking velocity as measured by the GaitRite||12 weeks|
|Secondary||Health Biomarkers as measured by blood analysis (insulin)||12 weeks|
|Secondary||Health Biomarkers as measured by blood analysis (lipids)||12 weeks|
|Secondary||Health Biomarkers as measured by blood analysis (fasting glucose)||12 weeks|
|Secondary||Anthropometric measurements (BMI)||12 weeks|
|Secondary||Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)||12 weeks|
|Secondary||Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b||12 weeks|
|Secondary||Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a||12 weeks|
|Secondary||Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a||12 weeks|
|Secondary||Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a||12 weeks|
|Secondary||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|
|Secondary||Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale||12 weeks|
|Secondary||Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale||12 weeks|
|Secondary||Pain intensity is measured by the PROMIS Pain Intensity Short Form||12 weeks|
|Secondary||Body Composition as measured using a DEXA scan||12 weeks|
|Secondary||Loneliness as measured by the Three-item loneliness scale||12 weeks|