Clinical trial NCT03108950: From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
Official title: Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Stroke
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
First posted: 2017-04-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cardiorespiratory Fitness as measured by sub-maximal VO2
timeFrame: 12 weeks
measure: Pain as measured by PROMIS Pain Interference Short Form 8a
timeFrame: 12 weeks
measure: Fatigue as measured by PROMIS Fatigue Short Form 8a
timeFrame: 12 weeks
measure: Grip Strength as measured by hand grip dynamometer
timeFrame: 12 weeks
measure: Strength as measured by Biodex System 3 Multijoint dynamometer
timeFrame: 12 weeks
measure: Balance as measured by the Timed Up and Go
timeFrame: 12 weeks
measure: Balance as measured by Biodex Limits of Stability
timeFrame: 12 weeks
measure: Balance as measured by Repeated Chair Stands
timeFrame: 12 weeks
measure: Walking velocity as measured by the GaitRite
timeFrame: 12 weeks
Secondary outcomes:
measure: Health Biomarkers as measured by blood analysis (insulin)
timeFrame: 12 weeks
measure: Health Biomarkers as measured by blood analysis (lipids)
timeFrame: 12 weeks
measure: Health Biomarkers as measured by blood analysis (fasting glucose)
timeFrame: 12 weeks
measure: Anthropometric measurements (BMI)
timeFrame: 12 weeks
measure: Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
timeFrame: 12 weeks
measure: Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
timeFrame: 12 weeks
measure: Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
timeFrame: 12 weeks
measure: Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
timeFrame: 12 weeks
measure: Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
timeFrame: 12 weeks
measure: Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
timeFrame: 12 weeks
measure: Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
timeFrame: 12 weeks
measure: Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
timeFrame: 12 weeks
measure: Pain intensity is measured by the PROMIS Pain Intensity Short Form
timeFrame: 12 weeks
measure: Body Composition as measured using a DEXA scan
timeFrame: 12 weeks
measure: Loneliness as measured by the Three-item loneliness scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James Rimmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rimmer JH, Herman C, Wingo B, Fontaine K, Mehta T. Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability. BMC Med Res Methodol. 2018 Mar 14;18(1):28. doi: 10.1186/s12874-018-0480-3.