Viewing Study NCT06233370



Ignite Creation Date: 2024-05-06 @ 8:03 PM
Last Modification Date: 2024-10-26 @ 3:19 PM
Study NCT ID: NCT06233370
Status: RECRUITING
Last Update Posted: 2024-04-04
First Post: 2023-12-18

Brief Title: Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
Sponsor: Kessler Foundation
Organization: Kessler Foundation

Study Overview

Official Title: Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRIMERS
Brief Summary: The project will involve a within-subjects repeated-measures research design Participants will initially be screened for relevant inclusionexclusion criteria for maximizing safety of participating in an exercise study If a participant meets those inclusionexclusion 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 ie 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 ie pre-treadmill post-treadmill pre-overground post-overground
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None