Walking Exercise for Multiple Sclerosis

(PRIMERS Trial)

Overseen By Grace Wells, BS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Kessler Foundation

Must not be taking: Antipsychotics, Benzodiazepines

Disqualifiers: Major depressive disorder, Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. If a participant meets those inclusion/exclusion criteria, they will visit Kessler Foundation three times. The first visit will involve a baseline session where participants will complete several cognitive tests. This will be followed by a training session, where participants will be provided with a FitBit, and will be trained by research staff to walk at a rate of 100 steps per minute. Once participants demonstrate proficiency at walking at this rate using the FitBit, participants will complete several questionnaires, followed by a maximal, graded exercise test to determine cardiorespiratory fitness. One week later, participants will return to Kessler Foundation to complete 1 of 2 experimental sessions that will be delivered in a random order that further will be counterbalanced across participants (to minimize the potential effects of session order on brain function and blood flow, respectively). Both experimental sessions will follow the same structure. First, participants will undertake a 30-minute MRI scan at Kessler Foundation to measure brain function and brain blood flow. Immediately following the MRI scan, participants will engage in either 20 minutes of treadmill walking exercise or 20 minutes of overground walking exercise at a rate of 100 steps per minute. Immediately following the 20-minute exercise bouts, participants will undertake another MRI scan for measuring brain function and brain blood flow. Participants will return to Kessler Foundation a third time to complete the opposite experimental session that was not completed during the second visit (i.e., overground walking exercise if treadmill walking exercise was completed during the second visit). In total, each participant will undergo four MRI scans over the course of the study (i.e., pre-treadmill, post-treadmill, pre-overground, post-overground). .

Eligibility Criteria

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

I am at low risk for complications from an MRI.

I am at low risk for complications from exercise testing.

I have been free from cancer relapse for at least 30 days.

Exclusion Criteria

I have been diagnosed with a major mental health condition that is not well-controlled.

I am taking medication that could affect my thinking.

I was moderately active before my MS diagnosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

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.

1 week

1 visit (in-person)

Experimental Sessions

Participants complete two experimental sessions involving MRI scans and walking exercises (treadmill and overground) at 100 steps per minute.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Moderate intensity walking exercise

Trial Overview The study examines how moderate intensity walking affects brain function in people with Multiple Sclerosis. Participants will have MRI scans before and after treadmill or overground walking exercises to measure changes in brain activity and blood flow.

Participant Groups

Group I: Treadmill walking exercise Experimental Treatment 1 Intervention

Participants will walk on a motor-driven treadmill at a step rate of \~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps.

Group II: Over ground walking exercise Experimental Treatment 1 Intervention

Participants will walk around a square hallway at a step rate of \~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+