Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— PRIMERS  

Official title:

Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233370
• Other study ID #: R-1234-23
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Kessler Foundation
• Contact: Brian M Sandroff, PhD
• Phone: 973-965-6649
• Email: bsandroff[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Moderate 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)

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aerobic fitness	Cardiorespiratory fitness (i.e., peak oxygen consumption (VO2peak)) based on a maximal graded exercise test on a motor-driven treadmill	Week 1
Other	Average steps per day	Free-living physical activity based on average steps per day measured by an ActiGraph accelerometer for a 7-day period	Week 1
Other	Cognitive processing speed	Performance on the Symbol Digit Modalities Test (raw score). Higher scores are indicative of faster cognitive processing speed	Week 1
Other	Aerobic fitness	Cardiorespiratory fitness (i.e., time to exhaustion) based on a maximal graded exercise test on a motor-driven treadmill	Week 1
Other	Verbal learning and memory	Performance on the California Verbal Learning Test II (raw score). Higher scores are indicative of better learning and memory	Week 1
Other	Visuospatial learning and memory	Performance on the Brief Visuospatial Memory Test-Revised (raw score). Higher scores are indicative of better visuospatial learning and memory	Week 1
Other	Time spent in moderate-to-vigorous physical activity	Free-living physical activity based on time spent in moderate-to-vigorous activity measured by an ActiGraph accelerometer for a 7-day period	Week 1
Primary	Brain Function	MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain	Weeks 2 and 3
Primary	Brain Blood Flow	MRI-measured cerebral blood flow perfusion in the left and right hemispheres	Weeks 2 and 3