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Behavioural Intervention

Walking Exercise for Multiple Sclerosis (PRIMERS Trial)

Phase < 1

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapse-free for at least 30 days

Clinically-definite MS diagnosis

Must not have

Diagnosis of uncontrolled major depressive disorder, schizophrenia, bipolar disorder I or II, or substance use disorders

Taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2 and 3

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve participants who will be screened to make sure they can safely participate in an exercise study. If they meet the criteria, they will visit the Kessler Foundation three times. During the first

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves moderate walking exercise, potential side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. The risk of falls could also be considered for those with mobility issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been officially diagnosed with multiple sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am taking medication that could affect my thinking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2 and 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2 and 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2 and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Blood Flow

Brain Function

Other study objectives

Aerobic fitness

Average steps per day

Cognitive processing speed

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treadmill walking exerciseExperimental Treatment1 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 exerciseExperimental Treatment1 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.

0 / 4Eligibility criteria met