Skip to main content
OpenTrials
Completed

NCT Number: NCT03108950

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Movement to Music

Behavioral

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 names: M2M

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Lakeshore Foundation

Registry information

Official study title

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

Acronym: TExT-ME

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.