Walking Exercise for Multiple Sclerosis
(PRIMERS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different types of walking exercises can benefit people with multiple sclerosis (MS) by examining changes in brain function and blood flow. Participants will walk at a moderate pace, either on a treadmill or around a hallway, while researchers use MRI scans to assess the effects on the brain. The trial suits those with a confirmed MS diagnosis, who have not experienced a relapse in the last month, and who were either very physically active or inactive before their diagnosis. As an Early Phase 1 trial, this research aims to understand how walking exercises affect brain function in people with MS, offering participants the opportunity to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
If you are taking medications that can affect cognition, like antipsychotics or benzodiazepines, you may not be eligible to participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both treadmill walking and walking on the ground are generally safe for people with multiple sclerosis (MS). Studies on ground walking have found that it helps individuals walk more safely and cover longer distances. Participants increased their walking endurance by 56% and improved their safety while walking.
For treadmill walking, studies have demonstrated that people with MS handle it well. Treadmill training helps individuals walk faster and for longer periods. The training is also considered safe, and participants tend to adhere to it.
This trial is in an early stage, focusing primarily on safety. However, evidence from past studies on similar exercises suggests these activities are usually well-tolerated and safe.12345Why are researchers excited about this trial?
Researchers are excited about these walking exercise treatments for multiple sclerosis (MS) because they focus on a simple yet effective approach to improving mobility and fitness. Unlike conventional MS treatments, which often involve medication to manage symptoms, these exercises offer a non-pharmacological option that encourages physical activity. The trial compares two methods: over-ground walking and treadmill walking, both at a moderate intensity of about 100 steps per minute. This approach could empower people with MS to integrate manageable exercise routines into their daily lives, potentially enhancing their quality of life without the side effects associated with many medications.
What evidence suggests that this trial's walking exercises could be effective for multiple sclerosis?
Research has shown that exercise benefits people with multiple sclerosis (MS) in many ways. In this trial, participants will engage in either over-ground walking exercise or treadmill walking exercise. For walking on regular ground, studies have found improvements in distance and safety, with one study reporting a 56% increase in walking endurance after exercise. Treadmill walking also increases walking distance and makes walking feel easier. Both types of walking exercises in this trial aim to improve walking ability and reduce tiredness for those with MS. These findings suggest that moderate-intensity walking exercises can effectively manage MS symptoms.12367
Are You a Good Fit for This Trial?
This trial is for individuals with Multiple Sclerosis who can safely participate in exercise studies. They'll need to visit the Kessler Foundation three times, be able to walk at a set pace with a FitBit, and pass cognitive tests and fitness assessments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Training
Participants complete cognitive tests, receive a FitBit, and are trained to walk at 100 steps per minute. A maximal graded exercise test is conducted to determine cardiorespiratory fitness.
Experimental Sessions
Participants complete two experimental sessions involving MRI scans and walking exercises (treadmill and overground) at 100 steps per minute.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Moderate intensity walking exercise
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor