Tele-Exercise and Multiple Sclerosis
TEAMS
Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)
2 other identifiers
interventional
911
1 country
40
Brief Summary
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups. \*\*On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.\*\*
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jan 2018
Longer than P75 for not_applicable multiple-sclerosis
40 active sites
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
First Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedResults Posted
Study results publicly available
December 11, 2024
CompletedDecember 11, 2024
December 1, 2024
3.8 years
April 5, 2017
April 1, 2024
December 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Pain
Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Fatigue
Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Quality of Life (Physical Component)
The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Quality of Life (Mental Component)
The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Physical Activity
Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Secondary Outcomes (6)
Change in Balance (Berg Balance Scale)
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Balance (Five Times Site to Stand)
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Endurance
48 weeks for DirectCAM and TeleCAM.
Change in Gait (Timed Up and Go)
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Gait (Timed 25-Foot Walk)
48 weeks for DirectCAM and TeleCAM.
- +1 more secondary outcomes
Other Outcomes (4)
Change in Outcome Expectations for Exercise
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Exercise Self-Efficacy
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Social Support for Exercise
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
- +1 more other outcomes
Study Arms (3)
DirectCAM
EXPERIMENTALThe DirectCAM arm receives the intervention content via therapists at participating clinics.
TeleCAM
EXPERIMENTALThe TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
rDirectCAM
EXPERIMENTALThe rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
Interventions
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
Eligibility Criteria
You may qualify if:
- Physician permission to participate in the study
- Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps \[PDDS\] 0 - 7
- Able to use arms/legs for exercise
You may not qualify if:
- Significant visual acuity that prevents seeing a tablet screen to follow home exercise program
- Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure
- Active pressure ulcers
- Currently pregnant
- Within 30 days of receiving a rehabilitation program
- Already meeting physical activity guidelines (GLTEQ \> 24)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Patient-Centered Outcomes Research Institutecollaborator
- Alabama Neurology Associates, PCcollaborator
- Lakeshore Foundationcollaborator
Study Sites (40)
Upstream Rehabilitation Inc.
Athens, Alabama, 35613, United States
Upstream Rehabilitation Inc.
Bessemer, Alabama, 35022, United States
Tanner Foundation
Birmingham, Alabama, 35209, United States
Upstream Rehabilitation Inc.
Calera, Alabama, 35040, United States
Upstream Rehabilitation Inc.
Cullman, Alabama, 35058, United States
Southeast Alabama Medical Center Rehabilitation Services
Dothan, Alabama, 36301, United States
Gulf Coast Therapy
Fairhope, Alabama, 36532, United States
Gulf Coast Therapy
Foley, Alabama, 36536, United States
Encore Rehabilitation
Fort Payne, Alabama, 35967, United States
Upstream Rehabilitation Inc.
Gadsden, Alabama, 35906, United States
Therapy Achievements
Huntsville, Alabama, 35801, United States
Upstream Rehabilitation Inc.
Jacksonville, Alabama, 36265, United States
Upstream Rehabilitation Inc.
Jasper, Alabama, 35501, United States
Gulf Coast Therapy
Mobile, Alabama, 36607, United States
Montgomery East Physical Therapy
Montgomery, Alabama, 36117, United States
Upstream Rehabilitation Inc.
Muscle Shoals, Alabama, 35674, United States
Encore Rehabilitation
Phenix City, Alabama, 36867, United States
Upstream Rehabilitation Inc.
Tuscaloosa, Alabama, 35046, United States
Cornerstone Rehabilitation
Batesville, Mississippi, 38668, United States
Upstream Rehabilitation Inc.
Byram, Mississippi, 39272, United States
Upstream Rehabilitation Inc.
Canton, Mississippi, 39046, United States
Upstream Rehabilitation Inc.
Columbus, Mississippi, 39702, United States
Upstrem Rehabilitation
Forest, Mississippi, 39074, United States
Upstream Rehabilitation Inc.
Fulton, Mississippi, 38843, United States
River City Rehabilitation
Greenville, Mississippi, 38703, United States
Encore Rehabilitation
Grenada, Mississippi, 38901, United States
Upstream Rehabilitation Inc.
Hattiesburg, Mississippi, 39402, United States
Methodist Rehabilitation Center
Jackson, Mississippi, 39216, United States
Encore Rehabilitation
Ocean Springs, Mississippi, 39564, United States
North Sunflower Medical Center
Ruleville, Mississippi, 38771, United States
Cornerstone Rehabilitation
Southaven, Mississippi, 38671, United States
Upstream Rehabilitation Inc.
Starkville, Mississippi, 39759, United States
Upstream Rehabilitation Inc.
Tupelo, Mississippi, 38801, United States
Cornerstone Rehabilitation
Water Valley, Mississippi, 38965, United States
Upstream Rehabilitation Inc.
Bristol, Tennessee, 37620, United States
Upstream Rehabilitation Inc.
Cool Springs, Tennessee, 37067, United States
Upstream Rehabilitation Inc.
Gordonsville, Tennessee, 38563, United States
Upstream Rehabilitation Inc.
Knoxville, Tennessee, 37931, United States
Upstream Rehabilitation Inc.
Newport, Tennessee, 37821, United States
Upstream Rehabilitation Inc.
Winchester, Tennessee, 37398, United States
Related Publications (3)
Tracy TF, Young HJ, Lai B, Layton B, Stokes D, Fry M, Mehta T, Riser ES, Rimmer J. Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis. Res Involv Engagem. 2022 Jul 29;8(1):35. doi: 10.1186/s40900-022-00366-6.
PMID: 35906699DERIVEDLai B, Chiu CY, Pounds E, Tracy T, Mehta T, Young HJ, Riser E, Rimmer J. COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 3;9(7):e18415. doi: 10.2196/18415.
PMID: 32540838DERIVEDRimmer JH, Thirumalai M, Young HJ, Pekmezi D, Tracy T, Riser E, Mehta T. Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. Contemp Clin Trials. 2018 Aug;71:186-193. doi: 10.1016/j.cct.2018.05.016. Epub 2018 May 30.
PMID: 29859267DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Our study had some limitations, which include: 1) limitations in reimbursement for onsite clinic services; 2) apprehension and competency in using technology; 3) difficulty in following participants residing in low resource communities over time; 4) challenge in identifying rural clinic sites, resulting in less than 10% of our participants from rural areas; 5) much higher percentage of female participants.
Results Point of Contact
- Title
- Dr. Tapan Mehta
- Organization
- University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 18, 2017
Study Start
January 8, 2018
Primary Completion
October 30, 2021
Study Completion
October 30, 2022
Last Updated
December 11, 2024
Results First Posted
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share