Internet-Delivered Lifestyle Physical Activity Intervention for Cognit
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Behavioral Intervention for Physical Activity in MS (BIPAMS)
Placebo
- Wellness for MS (WellMS)
What it measured
Main measures
Cognition
Changes in cognition scores from Baseline, 6-Month, and 12-Month
Thinking and memory
Other measures (5)
Fatigue Severity
Changes in fatigue from Baseline, 6-Months, and 12-Months
FatigueFatigue Impact
Changes in fatigue from Baseline, 6-Months, and 12-Months
FatigueDepressive Symptoms
Changes in depressive symptoms from Baseline, 6-Month, and 12-Month
Mood and sleepAnxiety
Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month
Mood and sleepQuality of Life (QOL)
Changes in quality of life from Baseline, 6-Month, and 12-Month
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Mar 2023
Main results due
Oct 2026
Finished
Oct 2026