Multiple Sclerosis Clinical Trial
Tele-Exercise and Multiple Sclerosis
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.**
Full 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)
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There are 40 Locations for this study
Athens Alabama, 35613, United States
Bessemer Alabama, 35022, United States
Birmingham Alabama, 35209, United States
Calera Alabama, 35040, United States
Cullman Alabama, 35058, United States
Dothan Alabama, 36301, United States
Fairhope Alabama, 36532, United States
Foley Alabama, 36536, United States
Fort Payne Alabama, 35967, United States
Gadsden Alabama, 35906, United States
Huntsville Alabama, 35801, United States
Jacksonville Alabama, 36265, United States
Jasper Alabama, 35501, United States
Mobile Alabama, 36607, United States
Montgomery Alabama, 36117, United States
Muscle Shoals Alabama, 35674, United States
Phenix City Alabama, 36867, United States
Tuscaloosa Alabama, 35046, United States
Batesville Mississippi, 38668, United States
Byram Mississippi, 39272, United States
Canton Mississippi, 39046, United States
Columbus Mississippi, 39702, United States
Forest Mississippi, 39074, United States
Fulton Mississippi, 38843, United States
Greenville Mississippi, 38703, United States
Grenada Mississippi, 38901, United States
Hattiesburg Mississippi, 39402, United States
Jackson Mississippi, 39216, United States
Ocean Springs Mississippi, 39564, United States
Ruleville Mississippi, 38771, United States
Southaven Mississippi, 38671, United States
Starkville Mississippi, 39759, United States
Tupelo Mississippi, 38801, United States
Water Valley Mississippi, 38965, United States
Bristol Tennessee, 37620, United States
Cool Springs Tennessee, 37067, United States
Gordonsville Tennessee, 38563, United States
Knoxville Tennessee, 37931, United States
Newport Tennessee, 37821, United States
Winchester Tennessee, 37398, United States
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