RecruitingNot ApplicableNCT04518657

Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis


Sponsor

University of Illinois at Chicago

Enrollment

280 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an internet-delivered physical activity program to see if increasing lifestyle exercise can improve thinking speed and mental processing in people with multiple sclerosis (MS). **You may be eligible if...** - You live in the United States - You are 18 or older and have a diagnosis of MS - English is your primary language - You have not had a relapse in the past 30 days - You are currently not physically active - You are able to walk without assistance - You have internet and email access **You may NOT be eligible if...** - You are already regularly physically active - You recently had an MS relapse - You cannot walk independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBehavioral Intervention for Physical Activity in MS (BIPAMS)

A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.

BEHAVIORALWellness for MS (WellMS)

A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing wellness in people with MS.


Locations(1)

University of Illinois at Chicago

Chicago, Illinois, United States

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NCT04518657


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