Multiple SclerosisTExT-MENCT03108950
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings
A study testing Movement to Music in people with Multiple Sclerosis and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Stroke
- What is being tested?
- Movement to Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Current tobacco user or quit within the last six months
- Current use of medications for psychosis
- Active pressure ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Stroke
- Being tested
- Movement to Music
- Medical subject headings
- Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement to MusicBehavioural
Also called M2M
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Movement to Music | Experimental | 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. Receives: Behavioral: Movement to Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Pain as measured by PROMIS Pain Interference Short Form 8a
PROMIS Pain Interference Short Form 8a Questionnaire
Measured: 12 weeks
Fatigue as measured by PROMIS Fatigue Short Form 8a
PROMIS Fatigue Short Form 8a Questionnaire
Measured: 12 weeks
Grip Strength as measured by hand grip dynamometer
Participants exert as much force as possible using a Jamar hand grip dynamometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Walking velocity as measured by the GaitRite
20 meter walk is completed on the GaitRite mat
Measured: 12 weeks
Secondary outcomes (15)
Health Biomarkers as measured by blood analysis (insulin)
Participants undergo a fasted blood draw to assess insulin
Measured: 12 weeks
Health Biomarkers as measured by blood analysis (lipids)
Participants undergo a fasted blood draw to assess lipids
Measured: 12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)
Participants undergo a fasted blood draw to assess glucose
Measured: 12 weeks
Anthropometric measurements (BMI)
height and weight are assessed to compute BMI
Measured: 12 weeks
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)
Measured: 12 weeks
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
PROMIS Physical Function with Mobility Aid 455b questionnaire
Measured: 12 weeks
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
PROMIS Emotional Distress-Anxiety Short Form 8a questionnaire
Measured: 12 weeks
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
PROMIS Emotional Distress-Depression Short Form 8a questionnaire
Measured: 12 weeks
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
PROMIS Sleep Disturbance Short Form 8a questionnaire
Measured: 12 weeks
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
Measured: 12 weeks
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Nutrition Self-Efficacy Scale
Measured: 12 weeks
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Physical Exercise Self Efficacy Scale
Measured: 12 weeks
Pain intensity is measured by the PROMIS Pain Intensity Short Form
PROMIS Pain Intensity Short Form questionnaire
Measured: 12 weeks
Body Composition as measured using a DEXA scan
GE Lunar Dual X-ray Absorptiometry is used to assess total body composition
Measured: 12 weeks
Loneliness as measured by the Three-item loneliness scale
Three item loneliness scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Feb 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
- Investigators
- James Rimmer, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108950
- Sponsor's protocol ID
- F160404004
- Acronym
- TExT-ME
- Status last verified
- Aug 2019
- First submitted
- 5 Apr 2017
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29540164
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03108950
- Acronym / sponsor ID
- TExT-ME / F160404004
- Conditions
- Multiple Sclerosis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-Based Movement to Music | Experimental | Behavioral: Movement to MusicThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement to MusicAlso: M2MThe 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. | Behavioural | Home-Based Movement to Music |
Primary outcome
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
Pain as measured by PROMIS Pain Interference Short Form 8a
Time frame: 12 weeks
PROMIS Pain Interference Short Form 8a Questionnaire
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time frame: 12 weeks
PROMIS Fatigue Short Form 8a Questionnaire
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
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.
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.
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.
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.
Walking velocity as measured by the GaitRite
Time frame: 12 weeks
20 meter walk is completed on the GaitRite mat
15 secondary outcomes
Health Biomarkers as measured by blood analysis (insulin)
Time frame: 12 weeks
Health Biomarkers as measured by blood analysis (lipids)
Time frame: 12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)
Time frame: 12 weeks
Anthropometric measurements (BMI)
Time frame: 12 weeks
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Time frame: 12 weeks
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Time frame: 12 weeks
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Time frame: 12 weeks
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Time frame: 12 weeks
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Time frame: 12 weeks
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
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Time frame: 12 weeks
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Time frame: 12 weeks
Pain intensity is measured by the PROMIS Pain Intensity Short Form
Time frame: 12 weeks
Body Composition as measured using a DEXA scan
Time frame: 12 weeks
Loneliness as measured by the Three-item loneliness scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 29540164Rimmer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Rimmer, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement to Music in people with Multiple Sclerosis and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness as measured by sub-maximal VO2 (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.