Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

NCT06233370 | Active Not Recruiting Early Phase 1

• 1 other identifier: R-1234-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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). .

Conditions

Multiple Sclerosis

Keywords

exercise; MRI; walking

Outcome Measures

Primary Outcomes (2)

• Brain Function

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

  Weeks 2 and 3

• Brain Blood Flow

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

  Weeks 2 and 3

Other Outcomes (7)

• Aerobic fitness

  Week 1

• Average steps per day

  Week 1

• Cognitive processing speed

  Week 1

Study Arms (2)

Over ground walking exercise

EXPERIMENTAL

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.

Behavioral: Moderate intensity walking exercise

Treadmill walking exercise

EXPERIMENTAL

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.

Behavioral: Moderate intensity walking exercise

Interventions

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)

Over ground walking exercise; Treadmill walking exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Participants will complete two single bouts of walking exercise. One bout of walking exercise involves walking at a moderate intensity over ground, and the other bout of walking exercise involves walking at a moderate intensity on a treadmill. The order of walking exercise bouts will be randomly determined and counterbalanced across participants. Before and after each bout of walking exercise, participants will complete an MRI scan to measure brain connectivity and brain blood flow.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 31, 2024
• Study Start: March 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)