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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)

Primary Purpose

Multiple Sclerosis, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement to Music
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lakeshore Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-Based Movement to Music

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Pain as measured by PROMIS Pain Interference Short Form 8a
PROMIS Pain Interference Short Form 8a Questionnaire
Fatigue as measured by PROMIS Fatigue Short Form 8a
PROMIS Fatigue Short Form 8a Questionnaire
Grip Strength as measured by hand grip dynamometer
Participants exert as much force as possible using a Jamar hand grip dynamometer
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.
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.
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.
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.
Walking velocity as measured by the GaitRite
20 meter walk is completed on the GaitRite mat

Secondary Outcome Measures

Health Biomarkers as measured by blood analysis (insulin)
Participants undergo a fasted blood draw to assess insulin
Health Biomarkers as measured by blood analysis (lipids)
Participants undergo a fasted blood draw to assess lipids
Health Biomarkers as measured by blood analysis (fasting glucose)
Participants undergo a fasted blood draw to assess glucose
Anthropometric measurements (BMI)
height and weight are assessed to compute BMI
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)
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
PROMIS Physical Function with Mobility Aid 455b questionnaire
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
PROMIS Emotional Distress-Depression Short Form 8a questionnaire
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
PROMIS Sleep Disturbance Short Form 8a questionnaire
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
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Nutrition Self-Efficacy Scale
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Physical Exercise Self Efficacy Scale
Pain intensity is measured by the PROMIS Pain Intensity Short Form
PROMIS Pain Intensity Short Form questionnaire
Body Composition as measured using a DEXA scan
GE Lunar Dual X-ray Absorptiometry is used to assess total body composition
Loneliness as measured by the Three-item loneliness scale
Three item loneliness scale

Full Information

First Posted
April 5, 2017
Last Updated
August 1, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03108950
Brief Title
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
Acronym
TExT-ME
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-Based Movement to Music
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Movement to Music
Other Intervention Name(s)
M2M
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness as measured by sub-maximal VO2
Description
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
Time Frame
12 weeks
Title
Pain as measured by PROMIS Pain Interference Short Form 8a
Description
PROMIS Pain Interference Short Form 8a Questionnaire
Time Frame
12 weeks
Title
Fatigue as measured by PROMIS Fatigue Short Form 8a
Description
PROMIS Fatigue Short Form 8a Questionnaire
Time Frame
12 weeks
Title
Grip Strength as measured by hand grip dynamometer
Description
Participants exert as much force as possible using a Jamar hand grip dynamometer
Time Frame
12 weeks
Title
Strength as measured by Biodex System 3 Multijoint dynamometer
Description
Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.
Time Frame
12 weeks
Title
Balance as measured by the Timed Up and Go
Description
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.
Time Frame
12 weeks
Title
Balance as measured by Biodex Limits of Stability
Description
The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
Time Frame
12 weeks
Title
Balance as measured by Repeated Chair Stands
Description
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.
Time Frame
12 weeks
Title
Walking velocity as measured by the GaitRite
Description
20 meter walk is completed on the GaitRite mat
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health Biomarkers as measured by blood analysis (insulin)
Description
Participants undergo a fasted blood draw to assess insulin
Time Frame
12 weeks
Title
Health Biomarkers as measured by blood analysis (lipids)
Description
Participants undergo a fasted blood draw to assess lipids
Time Frame
12 weeks
Title
Health Biomarkers as measured by blood analysis (fasting glucose)
Description
Participants undergo a fasted blood draw to assess glucose
Time Frame
12 weeks
Title
Anthropometric measurements (BMI)
Description
height and weight are assessed to compute BMI
Time Frame
12 weeks
Title
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Description
circumference measures are completed at the neck, hip, and waist. Waist to hip ratios are computed (A/G ratio)
Time Frame
12 weeks
Title
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Description
PROMIS Physical Function with Mobility Aid 455b questionnaire
Time Frame
12 weeks
Title
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Description
PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire
Time Frame
12 weeks
Title
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Description
PROMIS Emotional Distress-Depression Short Form 8a questionnaire
Time Frame
12 weeks
Title
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Description
PROMIS Sleep Disturbance Short Form 8a questionnaire
Time Frame
12 weeks
Title
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Description
PROMIS Ability to Participate in Social Roles and Activities Short Form 8a questionnaire
Time Frame
12 weeks
Title
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Description
Nutrition Self-Efficacy Scale
Time Frame
12 weeks
Title
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Description
Physical Exercise Self Efficacy Scale
Time Frame
12 weeks
Title
Pain intensity is measured by the PROMIS Pain Intensity Short Form
Description
PROMIS Pain Intensity Short Form questionnaire
Time Frame
12 weeks
Title
Body Composition as measured using a DEXA scan
Description
GE Lunar Dual X-ray Absorptiometry is used to assess total body composition
Time Frame
12 weeks
Title
Loneliness as measured by the Three-item loneliness scale
Description
Three item loneliness scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Rimmer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeshore Foundation
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29540164
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.
Results Reference
derived

Learn more about this trial

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

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