From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
TExT-ME
Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Feb 2017
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedAugust 5, 2019
August 1, 2019
2.3 years
April 5, 2017
August 1, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
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 Outcomes (15)
Health Biomarkers as measured by blood analysis (insulin)
12 weeks
Health Biomarkers as measured by blood analysis (lipids)
12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)
12 weeks
Anthropometric measurements (BMI)
12 weeks
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
12 weeks
- +10 more secondary outcomes
Study Arms (1)
Home-Based Movement to Music
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Lakeshore Foundationcollaborator
Study Sites (1)
Lakeshore Foundation
Birmingham, Alabama, 35209, United States
Related Publications (1)
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.
PMID: 29540164DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Rimmer, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 11, 2017
Study Start
February 1, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
August 5, 2019
Record last verified: 2019-08