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.\*\*
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
911
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.
Upstream Rehabilitation Inc.
Athens, Alabama, United States
Upstream Rehabilitation Inc.
Bessemer, Alabama, United States
Tanner Foundation
Birmingham, Alabama, United States
Upstream Rehabilitation Inc.
Calera, Alabama, United States
Upstream Rehabilitation Inc.
Cullman, Alabama, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
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.
Time frame: 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.
Time frame: 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.
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Southeast Alabama Medical Center Rehabilitation Services
Dothan, Alabama, United States
Gulf Coast Therapy
Fairhope, Alabama, United States
Gulf Coast Therapy
Foley, Alabama, United States
Encore Rehabilitation
Fort Payne, Alabama, United States
Upstream Rehabilitation Inc.
Gadsden, Alabama, United States
...and 30 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.