Online Physical Activity Program for Multiple Sclerosis
(BIPAMS-Cog Trial)
Trial Summary
What is the purpose of this trial?
We propose a highly-informed, well-designed randomized controlled trial (RCT) that is critical for providing Class I evidence regarding an Internet-delivered physical activity (PA) intervention as a behavioral approach for managing slowed cognitive processing speed (CPS; the most common and perhaps most burdensome MS-related cognitive impairment) and its second learning and memory, symptomatic, and quality of life (QOL) correlates among fully-ambulatory persons with multiple sclerosis (MS) who present with CPS impairment. Such an approach will involve a single-blind, RCT that examines the effects of a remotely-delivered, Internet-based PA intervention compared with an active control condition for yielding immediate and sustained improvements in CPS, learning and memory, symptomatic, and QOL outcomes among persons with mild MS-related ambulatory impairment who demonstrate impaired CPS. The primary outcome is the raw (unadjusted), oral Symbol Digit Modalities Test (SDMT) score as a neuropsychological measure of CPS, and this will be collected remotely via screen-sharing technology. The secondary outcomes include an objective neuropsychological measure of learning and memory (California Verbal Learning Test-II) collected remotely via screen-sharing technology, self-report measures of fatigue (Fatigue Severity Scale), depressive symptoms and anxiety (Hospital Anxiety and Depression Scale), pain (Short-Form, McGill Pain Questionnaire) and QOL (Multiple Sclerosis Impact Scale-29) that will be captured remotely using Qualtrics. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day that will be delivered and returned via pre-paid, pre-addressed envelopes through the United States Postal Service for generating a minimal clinically important difference value that guides the prescription of free-living PA for managing CPS impairment in clinical practice.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity rather than medication changes.
What data supports the effectiveness of the treatment Behavioral Intervention for Physical Activity in MS (BIPAMS)?
Research shows that web-based and telephone-administered physical activity programs can help people with multiple sclerosis (MS) increase their physical activity levels, improve self-efficacy (belief in one's ability to succeed), and enhance quality of life. These programs have also been effective in reducing fatigue and depression in individuals with MS.12345
Is the online physical activity program for multiple sclerosis safe for humans?
The research articles reviewed do not provide specific safety data for the online physical activity program for multiple sclerosis. However, they suggest that physical activity is generally beneficial for people with MS, and web-based interventions are increasingly used to promote exercise safely.34678
How is the WellMS treatment different from other treatments for multiple sclerosis?
Research Team
Robert Motl, Ph.D
Principal Investigator
University of Illinois at Chicago
Eligibility Criteria
This trial is for adults in the U.S. with Multiple Sclerosis who are physically inactive, can walk without help, and have had no MS relapses in the last 30 days. Participants must speak English, have internet access, be willing to answer questionnaires, wear an accelerometer device, and accept random assignment to one of two intervention groups.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-month Internet-delivered physical activity intervention focusing on walking during ambulatory activities of daily living
Follow-up
Participants are monitored for sustained improvements in cognitive processing speed, learning and memory, and quality of life
Treatment Details
Interventions
- Behavioral Intervention for Physical Activity in MS (BIPAMS)
- Wellness for MS (WellMS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
University of Illinois at Chicago
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator