SUMMARY: Investigators at eight sites nationwide are enrolling 400 people with MS who have walking impairment for a study comparing a home-based exercise program to a facility-based program. The study, called “STEP for MS,” is funded by the Patient-Centered Outcomes Research Institute (PCORI). Sites are enrolling in Alabama, Colorado, Georgia, Massachusetts, North Carolina, Ohio and Wisconsin.
DETAILS
Rationale: Research shows that exercise is good for people with MS and may decrease symptoms and improve health and walking ability. An exercise study called STEP for MS will compare the outcomes of a 16-week exercise program conducted at home to a program conducted in a gym facility. A trained “coach” will help participants learn how to do the exercises and will provide encouragement throughout the program.
Eligibility and Details: The trial is recruiting participants between the ages of 18 and 65 years, who are diagnosed with MS, and can commit to driving to the study site for assessments and to exercise two times per week. Participants can walk but have some difficulty, with or without the use of an assistive device such as a cane or walker, do not exercise regularly, have not had a relapse in the past month, and have reliable internet access.
Participants are randomly (by chance) assigned either to a group that can choose where to exercise (in a gym or at home), or to a group that is assigned to either a gym (facility) or home exercise. All participants complete the same exercises for 16 weeks. Participants do aerobic exercise (walking) and resistance training for about 30 to 60 minutes, two times a week.
Participants in the facility group exercise at a gym or rehab center. A coach supervises participants in this program in person as needed. The other group exercises at home or in their community. Participants in the home group exercise using a manual or videos provided through an online portal. A coach supervises participants as needed through online video calls.
Participants will come to the study site for testing and/or complete online questionnaires before starting the program, two months into the program, when the program ends, and 6 and 12 months after completing the program. The research team is evaluating whether the program has improved their walking, mobility, quality of life, and self-confidence to exercise, and to assess how often people exercise. In addition, the team is looking at whether people exercise more and have better quality of life when they can choose where their exercise program takes place compared with those who don’t choose.
Please note: COVID-19 safety procedures will vary slightly at each site but may include: temperature checks, wearing a mask, distancing from other people, and cleaning equipment in between participants.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you:
Atlanta, Georgia
Shepherd Center
Erica Sutton
Research Coordinator
404-367-1305
Erica.sutton@shepherd.org
Athens, Georgia
University of Georgia, Athens
Megan Ware
Research Coordinator
423-260-5045
megan.ware20@uga.edu
Birmingham, Alabama
University of Alabama, Birmingham
Petra Silic
Research Coordinator
205-975-1336
petra09@uab.edu
Boston, Massachusetts
Massachusetts General Hospital
Dr. Plummer
617-724-3103
PPlummer@mghihp.edu
Chapel Hill, North Carolina
University of North Carolina, Chapel Hill
Rachel Keen
Research coordinator
704-877-5636
rayray@live.unc.edu
Cleveland, Ohio
Cleveland Clinic
Darlene Stough
Research Coordinator
216-445-5877
stoughd@ccf.org
Denver, Colorado
University of Colorado, Denver
Holly Borland
Research recruitment specialist
303-724-4644
neurologyresearchpartners@cuanschutz.edu
Milwaukee, Wisconsin
Marquette University, Wisconsin
Heidi Feuling
Research Coordinator
414-801-2819
heidi.feuling@marquette.edu
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill.
Read more here.