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

Primary Purpose

Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GEMS Plus
GEMS
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Exercise, Cognition, Brain, Rehabilitation, Remote

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GEMS Plus

GEMS

Arm Description

Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS

Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in thalamic volume
Participants will undertake an MRI scan to measure volume of the thalamus as a secondary study outcome

Full Information

First Posted
February 23, 2023
Last Updated
February 23, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05755061
Brief Title
WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis
Official Title
Long-Term Aerobic Walking Exercise for Restoring Cognition and Brain in People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
Keywords
Exercise, Cognition, Brain, Rehabilitation, Remote

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GEMS Plus
Arm Type
Experimental
Arm Description
Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS
Arm Title
GEMS
Arm Type
Active Comparator
Arm Description
Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS
Intervention Type
Behavioral
Intervention Name(s)
GEMS Plus
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
GEMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in cognitive processing speed
Description
Participants will undertake the Symbol Digit Modalities Test as a cognitive test of cognitive processing speed as one of the primary study outcomes
Time Frame
Baseline; 6-months; 12-months
Title
Change in resting-state functional connectivity
Description
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
Time Frame
Baseline; 6-months; 12-months
Secondary Outcome Measure Information:
Title
Change in thalamic volume
Description
Participants will undertake an MRI scan to measure volume of the thalamus as a secondary study outcome
Time Frame
Baseline; 6-months; 12-months
Other Pre-specified Outcome Measures:
Title
Change in aerobic fitness
Description
Participants will undertake a maximal, graded exercise test on a treadmill to measure aerobic fitness
Time Frame
Baseline; 6-months; 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian M Sandroff, PhD
Phone
973.965.6649
Email
bsandroff@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Wells, BS
Phone
973.356.6458
Email
gwells@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian M Sandroff, PhD
Phone
973-965-6649
Email
bsandroff@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Grace Wells, BS
Phone
973.356.6458
Email
gwells@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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