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

Stroke Clinical Trial

— TExT-ME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108950
• Other study ID #: F160404004
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain as measured by PROMIS Pain Interference Short Form 8a	PROMIS Pain Interference Short Form 8a Questionnaire	12 weeks
Primary	Fatigue as measured by PROMIS Fatigue Short Form 8a	PROMIS Fatigue Short Form 8a Questionnaire	12 weeks
Primary	Grip Strength as measured by hand grip dynamometer	Participants exert as much force as possible using a Jamar hand grip dynamometer	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Walking velocity as measured by the GaitRite	20 meter walk is completed on the GaitRite mat	12 weeks
Secondary	Health Biomarkers as measured by blood analysis (insulin)	Participants undergo a fasted blood draw to assess insulin	12 weeks
Secondary	Health Biomarkers as measured by blood analysis (lipids)	Participants undergo a fasted blood draw to assess lipids	12 weeks
Secondary	Health Biomarkers as measured by blood analysis (fasting glucose)	Participants undergo a fasted blood draw to assess glucose	12 weeks
Secondary	Anthropometric measurements (BMI)	height and weight are assessed to compute BMI	12 weeks
Secondary	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
Secondary	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
Secondary	Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a	PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire	12 weeks
Secondary	Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a	PROMIS Emotional Distress-Depression Short Form 8a questionnaire	12 weeks
Secondary	Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a	PROMIS Sleep Disturbance Short Form 8a questionnaire	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	PROMIS Ability to Participate in Social Roles and Activities Short Form 8a questionnaire	12 weeks
Secondary	Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale	Nutrition Self-Efficacy Scale	12 weeks
Secondary	Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale	Physical Exercise Self Efficacy Scale	12 weeks
Secondary	Pain intensity is measured by the PROMIS Pain Intensity Short Form	PROMIS Pain Intensity Short Form questionnaire	12 weeks
Secondary	Body Composition as measured using a DEXA scan	GE Lunar Dual X-ray Absorptiometry is used to assess total body composition	12 weeks
Secondary	Loneliness as measured by the Three-item loneliness scale	Three item loneliness scale	12 weeks