Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05755061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-02-23
Brief Title:
WEBCAMS Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This study is a randomized controlled trial RCT that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed CPS brain MRI and other functional outcomes in 32 adults with multiple sclerosis MS who are able to walk without an assistive device but demonstrate slowed CPS Participants N32 will initially undergo screening via telephone and after satisfying relevant inclusionexclusion criteria will provide informed consent followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform ie Zoom for Healthcare This assessment will also serve as a screen for ensuring impaired CPS Following this virtual session participants will come into Kessler Foundation KF and complete a 3-hour baseline assessment T0 that includes a relatively short battery of neuropsychological tests a 40-minute MRI scan tests of walking function a short questionnaire packet followed by cardiopulmonary exercise testing on a motor-driven treadmill Following T0 participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants As the conditions are delivered and supported remotely by KF personnel the exercise itself takes place in the homecommunity setting Both conditions involve behavior coaching via Zoom for Healthcare The experimental condition involves high-frequency high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS GEMS GEMS initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12 The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines GEMS GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week Both conditions further will be monitored based on Fitbit-measured steps per exercise session Of note the sample size will be enrolled using 2 overlapping waves Wave 1 14 participants Wave 2 18 participants 3 months apart Participants will return to KF at the mid-point ie T6 and end-point ie T12 of the 12-month intervention period to complete the same assessments as T0 The T6 and T12 outcomes will be administered by treatment-blinded research assistants
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