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Tele-Exercise and Multiple Sclerosis

NCT ID: NCT03117881

Last Updated: 2024-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

911 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2022-10-30

Brief Summary

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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.\*\*

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis Yoga Pilates Telerehabilitation Physical activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DirectCAM

The DirectCAM arm receives the intervention content via therapists at participating clinics.

Group Type EXPERIMENTAL

DirectCAM

Intervention Type BEHAVIORAL

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.

TeleCAM

The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.

Group Type EXPERIMENTAL

TeleCAM

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

rDirectCAM

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Alabama Neurology Associates, PC

OTHER

Sponsor Role collaborator

Lakeshore Foundation

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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James Rimmer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Upstream Rehabilitation Inc.

Athens, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Bessemer, Alabama, United States

Site Status

Tanner Foundation

Birmingham, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Calera, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Cullman, Alabama, United States

Site Status

Southeast Alabama Medical Center Rehabilitation Services

Dothan, Alabama, United States

Site Status

Gulf Coast Therapy

Fairhope, Alabama, United States

Site Status

Gulf Coast Therapy

Foley, Alabama, United States

Site Status

Encore Rehabilitation

Fort Payne, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Gadsden, Alabama, United States

Site Status

Therapy Achievements

Huntsville, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Jacksonville, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Jasper, Alabama, United States

Site Status

Gulf Coast Therapy

Mobile, Alabama, United States

Site Status

Montgomery East Physical Therapy

Montgomery, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Muscle Shoals, Alabama, United States

Site Status

Encore Rehabilitation

Phenix City, Alabama, United States

Site Status

Upstream Rehabilitation Inc.

Tuscaloosa, Alabama, United States

Site Status

Cornerstone Rehabilitation

Batesville, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Byram, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Canton, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Columbus, Mississippi, United States

Site Status

Upstrem Rehabilitation

Forest, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Fulton, Mississippi, United States

Site Status

River City Rehabilitation

Greenville, Mississippi, United States

Site Status

Encore Rehabilitation

Grenada, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Hattiesburg, Mississippi, United States

Site Status

Methodist Rehabilitation Center

Jackson, Mississippi, United States

Site Status

Encore Rehabilitation

Ocean Springs, Mississippi, United States

Site Status

North Sunflower Medical Center

Ruleville, Mississippi, United States

Site Status

Cornerstone Rehabilitation

Southaven, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Starkville, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Tupelo, Mississippi, United States

Site Status

Cornerstone Rehabilitation

Water Valley, Mississippi, United States

Site Status

Upstream Rehabilitation Inc.

Bristol, Tennessee, United States

Site Status

Upstream Rehabilitation Inc.

Cool Springs, Tennessee, United States

Site Status

Upstream Rehabilitation Inc.

Gordonsville, Tennessee, United States

Site Status

Upstream Rehabilitation Inc.

Knoxville, Tennessee, United States

Site Status

Upstream Rehabilitation Inc.

Newport, Tennessee, United States

Site Status

Upstream Rehabilitation Inc.

Winchester, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35906699 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32540838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29859267 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MS-1511-33653

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F161017003

Identifier Type: -

Identifier Source: org_study_id