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Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06233370
Acronym
PRIMERS
Enrollment
24
Registered
2024-01-31
Start date
2024-03-01
Completion date
2026-12-31
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

exercise, MRI, walking

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). .

Interventions

BEHAVIORALModerate intensity walking exercise

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)

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brain FunctionWeeks 2 and 3MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain
Brain Blood FlowWeeks 2 and 3MRI-measured cerebral blood flow perfusion in the left and right hemispheres

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026