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Active, Not Recruiting

NCT Number: NCT06233370

Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

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). .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically-definite MS diagnosis
  • Relapse-free for at least 30 days
  • Low risk for contraindications for exercise testing
  • Low risk for contraindications for MRI
  • Historically physically inactive prior to MS diagnosis
  • Historically highly physically active prior to MS diagnosis

Exclusion criteria

  • 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)
  • Historically moderately physically active prior to MS diagnosis

Treatment and study plan

Moderate intensity walking exercise

Behavioral

For each intervention arm, participants will be walking at a moderate intensity, determined based on a step rate of approximately 100 steps per minute (measured by a Fitbit)

Primary outcomes

  1. Brain Function

    Time frame: Weeks 2 and 3

    MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain

  2. Brain Blood Flow

    Time frame: Weeks 2 and 3

    MRI-measured cerebral blood flow perfusion in the left and right hemispheres

Other outcomes

  1. Aerobic fitness

    Time frame: Week 1

    Cardiorespiratory fitness (i.e., peak oxygen consumption (VO2peak)) based on a maximal graded exercise test on a motor-driven treadmill

  2. Average steps per day

    Time frame: Week 1

    Free-living physical activity based on average steps per day measured by an ActiGraph accelerometer for a 7-day period

  3. Cognitive processing speed

    Time frame: Week 1

    Performance on the Symbol Digit Modalities Test (raw score). Higher scores are indicative of faster cognitive processing speed

  4. Aerobic fitness

    Time frame: Week 1

    Cardiorespiratory fitness (i.e., time to exhaustion) based on a maximal graded exercise test on a motor-driven treadmill

  5. Verbal learning and memory

    Time frame: Week 1

    Performance on the California Verbal Learning Test II (raw score). Higher scores are indicative of better learning and memory

  6. Visuospatial learning and memory

    Time frame: Week 1

    Performance on the Brief Visuospatial Memory Test-Revised (raw score). Higher scores are indicative of better visuospatial learning and memory

  7. Time spent in moderate-to-vigorous physical activity

    Time frame: Week 1

    Free-living physical activity based on time spent in moderate-to-vigorous activity measured by an ActiGraph accelerometer for a 7-day period

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Acronym: PRIMERS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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