WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05755061
• Other study ID #: R-1194-22
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• GEMS Plus
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
• GEMS
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

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	Change in aerobic fitness	Participants will undertake a maximal, graded exercise test on a treadmill to measure aerobic fitness	Baseline; 6-months; 12-months
Primary	Change in cognitive processing speed	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
Primary	Change in resting-state functional connectivity	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	Change in thalamic volume	Participants will undertake an MRI scan to measure volume of the thalamus as a secondary study outcome	Baseline; 6-months; 12-months