Clinical trial NCT06233370: Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
Official title: Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Multiple Sclerosis
Keywords: exercise
MRI
walking
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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). .


Eligibility criteria: 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

Primary outcomes:
measure: Brain Function
timeFrame: Weeks 2 and 3
measure: Brain Blood Flow
timeFrame: Weeks 2 and 3
Secondary outcomes:
Other outcomes:
measure: Aerobic fitness
timeFrame: Week 1
measure: Average steps per day
timeFrame: Week 1
measure: Cognitive processing speed
timeFrame: Week 1
measure: Aerobic fitness
timeFrame: Week 1
measure: Verbal learning and memory
timeFrame: Week 1
measure: Visuospatial learning and memory
timeFrame: Week 1
measure: Time spent in moderate-to-vigorous physical activity
timeFrame: Week 1
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: