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

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ClinicalTrials.gov Identifier: NCT03108950
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Lakeshore Foundation
Information provided by (Responsible Party):
James Rimmer, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Stroke Behavioral: Movement to Music Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-Based 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.
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.
Other Name: M2M




Primary Outcome Measures :
  1. Cardiorespiratory Fitness as measured by sub-maximal VO2 [ Time Frame: 12 weeks ]
    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

  2. Pain as measured by PROMIS Pain Interference Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Pain Interference Short Form 8a Questionnaire

  3. Fatigue as measured by PROMIS Fatigue Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Fatigue Short Form 8a Questionnaire

  4. Grip Strength as measured by hand grip dynamometer [ Time Frame: 12 weeks ]
    Participants exert as much force as possible using a Jamar hand grip dynamometer

  5. Strength as measured by Biodex System 3 Multijoint dynamometer [ Time Frame: 12 weeks ]
    Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.

  6. Balance as measured by the Timed Up and Go [ Time Frame: 12 weeks ]
    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.

  7. Balance as measured by Biodex Limits of Stability [ Time Frame: 12 weeks ]
    The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.

  8. Balance as measured by Repeated Chair Stands [ Time Frame: 12 weeks ]
    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.

  9. Walking velocity as measured by the GaitRite [ Time Frame: 12 weeks ]
    20 meter walk is completed on the GaitRite mat


Secondary Outcome Measures :
  1. Health Biomarkers as measured by blood analysis (insulin) [ Time Frame: 12 weeks ]
    Participants undergo a fasted blood draw to assess insulin

  2. Health Biomarkers as measured by blood analysis (lipids) [ Time Frame: 12 weeks ]
    Participants undergo a fasted blood draw to assess lipids

  3. Health Biomarkers as measured by blood analysis (fasting glucose) [ Time Frame: 12 weeks ]
    Participants undergo a fasted blood draw to assess glucose

  4. Anthropometric measurements (BMI) [ Time Frame: 12 weeks ]
    height and weight are assessed to compute BMI

  5. Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference) [ Time Frame: 12 weeks ]
    circumference measures are completed at the neck, hip, and waist. Waist to hip ratios are computed (A/G ratio)

  6. Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b [ Time Frame: 12 weeks ]
    PROMIS Physical Function with Mobility Aid 455b questionnaire

  7. Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire

  8. Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Emotional Distress-Depression Short Form 8a questionnaire

  9. Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Sleep Disturbance Short Form 8a questionnaire

  10. Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a [ Time Frame: 12 weeks ]
    PROMIS Ability to Participate in Social Roles and Activities Short Form 8a questionnaire

  11. Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale [ Time Frame: 12 weeks ]
    Nutrition Self-Efficacy Scale

  12. Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale [ Time Frame: 12 weeks ]
    Physical Exercise Self Efficacy Scale

  13. Pain intensity is measured by the PROMIS Pain Intensity Short Form [ Time Frame: 12 weeks ]
    PROMIS Pain Intensity Short Form questionnaire

  14. Body Composition as measured using a DEXA scan [ Time Frame: 12 weeks ]
    GE Lunar Dual X-ray Absorptiometry is used to assess total body composition

  15. Loneliness as measured by the Three-item loneliness scale [ Time Frame: 12 weeks ]
    Three item loneliness scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108950


Contacts
Contact: Cassandra Herman, MS 2054035504 caseyh@lakeshore.org
Contact: Ellie Moore, MS 2054035522 elliem@lakeshore.org

Locations
United States, Alabama
Lakeshore Foundation Recruiting
Birmingham, Alabama, United States, 35209
Contact: Casey L Herman    205-403-5504    caseyh@lakeshore.org   
Sponsors and Collaborators
University of Alabama at Birmingham
Lakeshore Foundation
Investigators
Principal Investigator: James Rimmer, PhD University of Alabama at Birmingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Rimmer, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03108950     History of Changes
Other Study ID Numbers: F160404004
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases