Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04518657

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

Led by University of Illinois at Chicago · Updated on 2026-01-06

280

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Residing in the United States
  • English is the primary language
  • Aged 18 years or older
  • Diagnosis of multiple sclerosis (MS)
  • No MS relapse in the past 30 days
  • Access to internet and email
  • Currently physically inactive
  • Able to walk without assistance
  • Willing to complete questionnaires
  • Willing to wear an accelerometer
  • Willing to be randomly assigned to either BIPAMS or WellMS intervention
Not Eligible

You will not qualify if you...

  • Not meeting all inclusion criteria
  • Moderate to high risk for injury or death from strenuous or maximal exercise according to PARQ

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

R

Robert W Motl, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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