Clinical trial NCT03117881: Tele-Exercise and Multiple Sclerosis
Official title: Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Yoga
Pilates
Telerehabilitation
Physical activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Alabama Neurology Associates, PC
name: Lakeshore Foundation
First posted: 2017-04-18
Enrollment: 911
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.\*\*

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pain
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Fatigue
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Quality of Life (Physical Component)
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Quality of Life (Mental Component)
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Physical Activity
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Secondary outcomes:
measure: Change in Balance (Berg Balance Scale)
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Balance (Five Times Site to Stand)
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Endurance
timeFrame: 48 weeks for DirectCAM and TeleCAM.
measure: Change in Gait (Timed Up and Go)
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Gait (Timed 25-Foot Walk)
timeFrame: 48 weeks for DirectCAM and TeleCAM.
measure: Change in Grip Strength
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Other outcomes:
measure: Change in Outcome Expectations for Exercise
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Exercise Self-Efficacy
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Social Support for Exercise
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
measure: Change in Exercise Self-Regulation
timeFrame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Locations:
city: Athens
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Bessemer
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Birmingham
country: United States
facility: Tanner Foundation
state: Alabama
city: Calera
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Cullman
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Dothan
country: United States
facility: Southeast Alabama Medical Center Rehabilitation Services
state: Alabama
city: Fairhope
country: United States
facility: Gulf Coast Therapy
state: Alabama
city: Foley
country: United States
facility: Gulf Coast Therapy
state: Alabama
city: Fort Payne
country: United States
facility: Encore Rehabilitation
state: Alabama
city: Gadsden
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Huntsville
country: United States
facility: Therapy Achievements
state: Alabama
city: Jacksonville
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Jasper
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Mobile
country: United States
facility: Gulf Coast Therapy
state: Alabama
city: Montgomery
country: United States
facility: Montgomery East Physical Therapy
state: Alabama
city: Muscle Shoals
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Phenix City
country: United States
facility: Encore Rehabilitation
state: Alabama
city: Tuscaloosa
country: United States
facility: Upstream Rehabilitation Inc.
state: Alabama
city: Batesville
country: United States
facility: Cornerstone Rehabilitation
state: Mississippi
city: Byram
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Canton
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Columbus
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Forest
country: United States
facility: Upstrem Rehabilitation
state: Mississippi
city: Fulton
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Greenville
country: United States
facility: River City Rehabilitation
state: Mississippi
city: Grenada
country: United States
facility: Encore Rehabilitation
state: Mississippi
city: Hattiesburg
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Jackson
country: United States
facility: Methodist Rehabilitation Center
state: Mississippi
city: Ocean Springs
country: United States
facility: Encore Rehabilitation
state: Mississippi
city: Ruleville
country: United States
facility: North Sunflower Medical Center
state: Mississippi
city: Southaven
country: United States
facility: Cornerstone Rehabilitation
state: Mississippi
city: Starkville
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Tupelo
country: United States
facility: Upstream Rehabilitation Inc.
state: Mississippi
city: Water Valley
country: United States
facility: Cornerstone Rehabilitation
state: Mississippi
city: Bristol
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
city: Cool Springs
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
city: Gordonsville
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
city: Knoxville
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
city: Newport
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
city: Winchester
country: United States
facility: Upstream Rehabilitation Inc.
state: Tennessee
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.