US Patients Urged to Enroll in STEP for MS Trial Assessing 2 Exercise Programs
Adults with mild to moderate multiple sclerosis (MS) are being urged to participate in a new clinical trial — STEP for MS — that will assess the impact of two different exercise programs on patients’ mobility, walking abilities, and quality of life.
Funded by the Patient-Centered Outcomes Research Institute (PCORI), the STEP for MS trial expects to enroll around 400 MS patients, ages 18–65, who have difficulties walking and do not exercise regularly.
STEP for MS is recruiting participants at eight sites across seven U.S. states. More information can be found here.
The trial’s main goal is to compare the effectiveness of two exercise programs — one carried out at home and the other at a gym facility — at easing MS symptoms and improving patients’ mobility and quality of life. All exercises will be taught to study participants by a certified coach, who also will offer encouragement throughout the entire study period.
Enrollment is open to all individuals diagnosed with MS who are still able to walk but have some difficulties doing so. The study seeks both patients who need a cane or a walker and those who do not require such assistive devices to move around. Additionally, to be eligible to participate in STEP for MS, patients must have not experienced a relapse in the month prior to enrollment. Participants also must have reliable internet access.
Following enrollment, patients will be randomly assigned to one of three groups. One group will be able to choose which type of exercise program, home or gym-based, they wish to engage in during the study. Participants in the other two groups will either be assigned exercises to be carried out at home, or be directed to conduct their program in a gym or rehabilitation facility.
Regardless of the group to which they are assigned, all patients will be asked to practice the same exercises, twice weekly, over a period of 16 weeks (around four months). Each exercise session will include walking and resistance training, and lasting around 30-to-60 minutes.
A trained coach will offer in-person individual supervision to those practicing exercises in the gym, and through online video calls to those completing the exercises at home. In both cases, individual assistance and supervision will be offered as needed. Patients completing the exercise program from home also will have access to a manual and several videos through an online portal.
Travel to the nearest study site will be required for the completion of certain tests and questionnaires. Study questionnaires will be completed five times in total: before starting the program; after completing two months (roughly half) of the program; after completing the entire program; and six and 12 months after finishing the trial.
Notably, participants will have to comply with safety procedures imposed by the COVID-19 pandemic, which includes having their body temperature measured, wearing a mask, and remaining at a safe distance from other people on the site.
In addition to assessing the effectiveness of the two exercise programs on patients’ walking abilities, mobility, and self-confidence to exercise, investigators also aim to determine whether people with MS have a better quality of life and are willing to exercise more often when they have the option to choose where these activities take place.
Patients wishing to learn more about the study, or their eligibility to participate, may reach out by phone or email to the nearest study site.