- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05755061
WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis
March 4, 2024 updated by: Brian Sandroff, Kessler Foundation
Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
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 (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., 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 home/community 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 (i.e., T6) and end-point (i.e., 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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
-
West Orange, New Jersey, United States, 07052
- Kessler Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Definite MS diagnosis
- Relapse-free for at least 30 days
- Have Internet access on a device larger than a smartphone
- Willingness and ability to travel to Kessler Foundation 3 times over a 12-month period
- Be insufficiently physically active
- Demonstrate low fall risk based on Activities Specific Balance Confidence scores
- Demonstrate low contraindications for exercise
- Right handedness
- English as a primary language
- Demonstrate low cognitive processing speed based on a Zoom-administered Symbol Digit Modalities Test
Exclusion Criteria:
- Acutely taken corticosteroids within 30 days of enrollment
- Use an assistive device (i.e., cane, crutch, walker, rollator) for ambulation
- Experienced a fall in the past 6 months
- Have uncontrolled major depressive disorder or history of bipolar disorder or schizophrenia
- Regularly taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
- Demonstrate contraindications for 3T MRI (i.e., having metal/shrapnel in the body, non-MRI compatible aneurysm clips)
- Have severe cognitive impairment causing an inability to follow directions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GEMS Plus
Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS
|
12-months of home-based walking exercise that occurs 3-5 days per week.
The program will progress up to intensities that exceed the published physical activity guidelines for adults with MS
|
Active Comparator: GEMS
Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS
|
12-months of home-based walking exercise that occurs 3-5 days per week.
The program will progress up to intensities that meet the published physical activity guidelines for adults with MS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive processing speed
Time Frame: Baseline; 6-months; 12-months
|
Participants will undertake the Symbol Digit Modalities Test as a cognitive test of cognitive processing speed as one of the primary study outcomes
|
Baseline; 6-months; 12-months
|
Change in resting-state functional connectivity
Time Frame: Baseline; 6-months; 12-months
|
Participants will undertake an fMRI scan to measure resting-state functional connectivity between the thalamus and other brain regions as one of the primary study outcomes
|
Baseline; 6-months; 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in thalamic volume
Time Frame: Baseline; 6-months; 12-months
|
Participants will undertake an MRI scan to measure volume of the thalamus as a secondary study outcome
|
Baseline; 6-months; 12-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in aerobic fitness
Time Frame: Baseline; 6-months; 12-months
|
Participants will undertake a maximal, graded exercise test on a treadmill to measure aerobic fitness
|
Baseline; 6-months; 12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
March 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-1194-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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