Multiple Sclerosis Clinical Trial

Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

Summary

The purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (RLS) severity in persons with multiple sclerosis (MS) and RLS. The study includes a proposed sample of 20 persons with MS and RLS that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.

View Full Description

Full Description

The primary aim of the proposed pilot RCT involves examining the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing RLS severity in persons with MS and RLS. Secondarily, the investigators will be assessing changes in sleep quality and daytime sleepiness following the behavioral intervention. The study includes a proposed sample of 20 persons with MS and RLS that will complete a baseline testing session for measures of physical activity, restless legs syndrome severity, sleep quality, and daytime sleepiness. Participants will then be randomized into one of two study arms: (1) a 16-week Social Cognitive Theory-based behavioral intervention aimed at increasing physical activity; or (2) 16-week waitlist control with the option of completing the intervention upon completion of the study. All participants will complete a follow-up testing session at the conclusion of each 16-week arm.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple sclerosis
Relapse free in the past 30 days
Positive screen for restless legs syndrome
Non-active (not engaging in 30 minutes of activity per day on more than 2 days per week in the previous six months)
Ambulatory without assistance
Internet and email access

Exclusion Criteria:

Diagnosis of radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia) renal disease, or diabetes
Screen at moderate or high risk for undertaking strenuous or maximal exercise

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT04061681

Recruitment Status:

Completed

Sponsor:

University of Alabama at Birmingham

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT04061681

Recruitment Status:

Completed

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider