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)

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.**

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: DirectCAM; Behavioral: TeleCAM; Behavioral: rDirectCAM

Detailed Description

There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and rehabilitation services for patients with MS, especially in mostly rural, low-income areas such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of rehabilitation services over the telephone and/or the Internet, can help fill service gaps for underserved MS patient populations in this region. The proposed study will determine if our evidence-based rehabilitation and exercise program produces similar health outcomes when delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi, and Tennessee.

**In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS into the rDirectCAM, where the 12-week program is delivered in real-time via videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation program can have a similar effect as when the program is offered in person.**

The outcomes that we hope to achieve through the proposed rehabilitation and exercise program, referred to as complementary alternative medicine, are improved physical activity, decreased pain and fatigue, and quality of life. We also seek to improve attitudes and behaviors related to physical activity, such as outcome expectations for physical activity, social support from family and friends for physical activity, self-efficacy (i.e., confidence in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will examine the variation in outcomes by patient characteristics such as age and severity of disability to determine for whom the intervention is effective.

This project is important to patients with MS because it seeks to reduce their barriers to receiving exercise treatment and increase the convenience and appeal of such programs through technology. Furthermore, findings and resources from this study will be quickly provided to MS patients and clinicians across the United States (e.g., via training webinars through our National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve the quality and reach of exercise treatment for patients with MS.

The patient and stakeholder partners include MS patients, caretakers, and clinicians, who have been actively guiding the development of this project. In stakeholder meetings, members have provided insight into exercise treatment needs and preferences (e.g., individually tailored approaches that account for varying levels of mobility); outcomes of interest to the patient population (e.g., pain, fatigue, quality of life); and strategies for engaging/motivating participants with MS who may be discouraged and experiencing fatigue and pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback will be important to our recruitment and retention success. Finally, the stakeholders will help make this project successful by continuing to emphasize the importance of long-term gains in health outcomes and promote (through NCHPAD) the sustainability of the program.

• Study Type: Interventional
• Enrollment (Actual): 911
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35613
      • Upstream Rehabilitation Inc.
    • Bessemer, Alabama, United States, 35022
      • Upstream Rehabilitation Inc.
    • Birmingham, Alabama, United States, 35209
      • Tanner Foundation
    • Calera, Alabama, United States, 35040
      • Upstream Rehabilitation Inc.
    • Cullman, Alabama, United States, 35058
      • Upstream Rehabilitation Inc.
    • Dothan, Alabama, United States, 36301
      • Southeast Alabama Medical Center Rehabilitation Services
    • Fairhope, Alabama, United States, 36532
      • Gulf Coast Therapy
    • Foley, Alabama, United States, 36536
      • Gulf Coast Therapy
    • Fort Payne, Alabama, United States, 35967
      • Encore Rehabilitation
    • Gadsden, Alabama, United States, 35906
      • Upstream Rehabilitation Inc.
    • Huntsville, Alabama, United States, 35801
      • Therapy Achievements
    • Jacksonville, Alabama, United States, 36265
      • Upstream Rehabilitation Inc.
    • Jasper, Alabama, United States, 35501
      • Upstream Rehabilitation Inc.
    • Mobile, Alabama, United States, 36607
      • Gulf Coast Therapy
    • Montgomery, Alabama, United States, 36117
      • Montgomery East Physical Therapy
    • Muscle Shoals, Alabama, United States, 35674
      • Upstream Rehabilitation Inc.
    • Phenix City, Alabama, United States, 36867
      • Encore Rehabilitation
    • Tuscaloosa, Alabama, United States, 35046
      • Upstream Rehabilitation Inc.
  • Mississippi
    • Batesville, Mississippi, United States, 38668
      • Cornerstone Rehabilitation
    • Byram, Mississippi, United States, 39272
      • Upstream Rehabilitation Inc.
    • Canton, Mississippi, United States, 39046
      • Upstream Rehabilitation Inc.
    • Columbus, Mississippi, United States, 39702
      • Upstream Rehabilitation Inc.
    • Forest, Mississippi, United States, 39074
      • Upstrem Rehabilitation
    • Fulton, Mississippi, United States, 38843
      • Upstream Rehabilitation Inc.
    • Greenville, Mississippi, United States, 38703
      • River City Rehabilitation
    • Grenada, Mississippi, United States, 38901
      • Encore Rehabilitation
    • Hattiesburg, Mississippi, United States, 39402
      • Upstream Rehabilitation Inc.
    • Jackson, Mississippi, United States, 39216
      • Methodist Rehabilitation Center
    • Ocean Springs, Mississippi, United States, 39564
      • Encore Rehabilitation
    • Ruleville, Mississippi, United States, 38771
      • North Sunflower Medical Center
    • Southaven, Mississippi, United States, 38671
      • Cornerstone Rehabilitation
    • Starkville, Mississippi, United States, 39759
      • Upstream Rehabilitation Inc.
    • Tupelo, Mississippi, United States, 38801
      • Upstream Rehabilitation Inc.
    • Water Valley, Mississippi, United States, 38965
      • Cornerstone Rehabilitation
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Upstream Rehabilitation Inc.
    • Cool Springs, Tennessee, United States, 37067
      • Upstream Rehabilitation Inc.
    • Gordonsville, Tennessee, United States, 38563
      • Upstream Rehabilitation Inc.
    • Knoxville, Tennessee, United States, 37931
      • Upstream Rehabilitation Inc.
    • Newport, Tennessee, United States, 37821
      • Upstream Rehabilitation Inc.
    • Winchester, Tennessee, United States, 37398
      • Upstream Rehabilitation Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DirectCAM; The DirectCAM arm receives the intervention content via therapists at participating clinics.	Behavioral: DirectCAM; 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.
Experimental: TeleCAM; The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.	Behavioral: TeleCAM; 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.
Experimental: rDirectCAM; The 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.	Behavioral: rDirectCAM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Balance (Berg Balance Scale)	Balance was measured using the Berg Balance Scale (BBS). The score ranges from 0 to 56, with a lower score indicating a higher risk of falling and a higher score indicating better functional mobility. 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 sizes for TeleCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.	48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Balance (Five Times Site to Stand)	Balance was measured by the Five Times Site to Stand (FTSTS) test. Less time (in seconds) used to complete the FTSTS test indicates better balance. 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 Endurance	Endurance was measured using the 6-Minute Walk Test (6MWT). More distance traveled (meters) within the 6 minutes indicates better walking endurance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. 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 sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.	48 weeks for DirectCAM and TeleCAM.
Change in Gait (Timed Up and Go)	Gait was measured by the Timed Up and Go (TUG) test. Less time (in seconds) taken to complete the TUG test indicates better gait. 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 Gait (Timed 25-Foot Walk)	Gait was measured using the Timed 25-Foot Walk (T25FW) test. Less time taken to complete the T25FW test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. 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 sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.	48 weeks for DirectCAM and TeleCAM.
Change in Grip Strength	Grip strength was measured using a hand-held dynamometer. The higher score measured in pounds (lbs) indicates better grip strength. 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Outcome Expectations for Exercise	Outcome expectations for exercise was measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES). The total score ranges from 15 to 75, with a higher score on the MOEES reflects greater positive expectations regarding the outcomes of exercise across the three domains (physical, social, and self-evaluative). 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 sizes for DirectCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.	48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Exercise Self-Efficacy	Exercise self-efficacy was measured by the Exercise Self-Efficacy Scale. The total score ranges from 0 to 100, with higher scores indicate better exercise self-efficacy. 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 Social Support for Exercise	Social support for exercise was measured by the Social Provisions Scale. The score ranges from 24 (1 point for each item) to 96 (4 points for each item), with higher scores indicate higher perceived social support and lower scores suggest lower perceived social support. 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 Exercise Self-Regulation	Exercise self-regulation was measured by the Exercise Goal-Setting Scale. The total score ranges from 10 to 50, with a higher score indicates better or more effective goal-setting behaviors in relation to exercise. 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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Patient-Centered Outcomes Research Institute; Lakeshore Foundation; Alabama Neurology Associates, PC

Publications and helpful links

General Publications

• 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.
• Lai 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.
• Rimmer 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Yoga; Physical activity; Telerehabilitation; Pilates
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: F161017003; MS-1511-33653 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No