TEAMS: Tele-Exercise and Multiple Sclerosis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03117881

Collaborator

Patient-Centered Outcomes Research Institute (Other), Alabama Neurology Associates, PC (Other), Lakeshore Foundation (Other)

912

Enrollment

Locations

Arms

60.7

Anticipated Duration (Months)

22.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: DirectCAM Behavioral: TeleCAM Behavioral: rDirectCAM	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

912 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)

Actual Study Start Date :

Jan 8, 2018

Actual Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Baseline Pain at Month 3 and Month 12 [48 weeks]
Measured by 36-Item Short Form Survey (SF-36).
Change in Baseline Fatigue at Month 3 and Month 12 [48 weeks]
Measured by Modified Fatigue Impact Scale (MFIS).
Change in Baseline Quality of Life at Month 3 and Month 12 [48 weeks]
Measured by 36-Item Short Form Survey (SF-36).
Change in Baseline Physical Activity at Month 3 and Month 12 [48 weeks]
Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ).

Secondary Outcome Measures

Change in Baseline Balance at Month 3 and Month 12 [48 weeks]
Measured using the Berg Balance Scale (BBS).
Change in Baseline Endurance at Month 3 and Month 12 [48 weeks]
Measured using the 6-minute Walk Test (6MWT).
Change in Baseline Gait at Month 3 and Month 12 [48 weeks]
Measured using the Timed 25-Foot Walk (T25-FW).
Change in Baseline Strength at Month 3 and Month 12 [48 weeks]
Measured using a hand-held dynamometer.

Other Outcome Measures

Outcome expectations for exercise [48 weeks]
Measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES).
Exercise self-efficacy [48 weeks]
Measured by the Exercise Self-efficacy Scale.
Social support for exercise [48 weeks]
Measured by the Social Provisions Scale.
Exercise self-regulation [48 weeks]
Measured by the Exercise Goal-setting Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Upstream Rehabilitation Inc.	Athens	Alabama	United States	35613
2	Upstream Rehabilitation Inc.	Bessemer	Alabama	United States	35022
3	Tanner Foundation	Birmingham	Alabama	United States	35209
4	Upstream Rehabilitation Inc.	Calera	Alabama	United States	35040
5	Upstream Rehabilitation Inc.	Cullman	Alabama	United States	35058
6	Southeast Alabama Medical Center Rehabilitation Services	Dothan	Alabama	United States	36301
7	Gulf Coast Therapy	Fairhope	Alabama	United States	36532
8	Gulf Coast Therapy	Foley	Alabama	United States	36536
9	Encore Rehabilitation	Fort Payne	Alabama	United States	35967
10	Upstream Rehabilitation Inc.	Gadsden	Alabama	United States	35906
11	Therapy Achievements	Huntsville	Alabama	United States	35801
12	Upstream Rehabilitation Inc.	Jacksonville	Alabama	United States	36265
13	Upstream Rehabilitation Inc.	Jasper	Alabama	United States	35501
14	Gulf Coast Therapy	Mobile	Alabama	United States	36607
15	Montgomery East Physical Therapy	Montgomery	Alabama	United States	36117
16	Upstream Rehabilitation Inc.	Muscle Shoals	Alabama	United States	35674
17	Encore Rehabilitation	Phenix City	Alabama	United States	36867
18	Upstream Rehabilitation Inc.	Tuscaloosa	Alabama	United States	35046
19	Cornerstone Rehabilitation	Batesville	Mississippi	United States	38668
20	Upstream Rehabilitation Inc.	Byram	Mississippi	United States	39272
21	Upstream Rehabilitation Inc.	Canton	Mississippi	United States	39046
22	Upstream Rehabilitation Inc.	Columbus	Mississippi	United States	39702
23	Upstrem Rehabilitation	Forest	Mississippi	United States	39074
24	Upstream Rehabilitation Inc.	Fulton	Mississippi	United States	38843
25	River City Rehabilitation	Greenville	Mississippi	United States	38703
26	Encore Rehabilitation	Grenada	Mississippi	United States	38901
27	Upstream Rehabilitation Inc.	Hattiesburg	Mississippi	United States	39402
28	Methodist Rehabilitation Center	Jackson	Mississippi	United States	39216
29	Encore Rehabilitation	Ocean Springs	Mississippi	United States	39564
30	North Sunflower Medical Center	Ruleville	Mississippi	United States	38771
31	Cornerstone Rehabilitation	Southaven	Mississippi	United States	38671
32	Upstream Rehabilitation Inc.	Starkville	Mississippi	United States	39759
33	Upstream Rehabilitation Inc.	Tupelo	Mississippi	United States	38801
34	Cornerstone Rehabilitation	Water Valley	Mississippi	United States	38965
35	Upstream Rehabilitation Inc.	Bristol	Tennessee	United States	37620
36	Upstream Rehabilitation Inc.	Cool Springs	Tennessee	United States	37067
37	Upstream Rehabilitation Inc.	Gordonsville	Tennessee	United States	38563
38	Upstream Rehabilitation Inc.	Knoxville	Tennessee	United States	37931
39	Upstream Rehabilitation Inc.	Newport	Tennessee	United States	37821
40	Upstream Rehabilitation Inc.	Winchester	Tennessee	United States	37398