Multiple Sclerosis Clinical Trial
— BIPAMS-CogOfficial title:
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | July 31, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Residing in the United States (residing in Alabama is not required) - English as primary language - Between 18+ years old - Diagnosis of MS - Relapse free in the past 30 days - Internet and email access - Currently physically inactive (GLTEQ) - Able to ambulate without assistance (self-report and PDDS) - Willingness to complete the questionnaires - Willingness to wear the accelerometer - Willingness to undergo random assignment (BIPAMS or WellMS) Exclusion Criteria: - Individuals not meeting above inclusion criteria - Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ) |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accelerometry | Device-based measure of physical activity and sedentary behavior (ActiGraph) | Changes in accelerometry data from Baseline, 6-Month, and 12-Month | |
Primary | Cognition | Symbol Digit Modalities Test (SDMT); scoring involves summing the correct number of substitutions within the 90 second interval (max = 110), higher score indicates better outcomes. | Changes in cognition scores from Baseline, 6-Month, and 12-Month | |
Secondary | Fatigue Severity | Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity. | Changes in fatigue from Baseline, 6-Months, and 12-Months | |
Secondary | Fatigue Impact | Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores indicate greater impact of fatigue on a patient's activities. | Changes in fatigue from Baseline, 6-Months, and 12-Months | |
Secondary | Depressive Symptoms | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in depressive symptoms from Baseline, 6-Month, and 12-Month | |
Secondary | Anxiety | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month | |
Secondary | Quality of Life (QOL) | Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes). | Changes in quality of life from Baseline, 6-Month, and 12-Month |
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