Clinical trial NCT04061681: Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
Official title: Efficacy of Project BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Restless Legs Syndrome
Keywords: Physical Activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two conditions that will be occurring simultaneously.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
timeFrame: Baseline
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
timeFrame: Follow-Up
measure: Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
timeFrame: Baseline
measure: Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
timeFrame: Follow-Up
Secondary outcomes:
measure: Sleep Quality as measured by the Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Sleep Quality as measured by the Pittsburgh Sleep Quality Index
timeFrame: Follow-up
measure: Sleep Quality as measured by accelerometry
timeFrame: Baseline
measure: Sleep Quality as measured by accelerometry
timeFrame: Follow-up
measure: Daytime Sleepiness as measured by the Epworth Sleepiness Scale
timeFrame: Baseline
measure: Daytime Sleepiness as measured by the Epworth Sleepiness Scale
timeFrame: Follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Robert W Motl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cederberg KLJ, Motl RW. Feasibility and efficacy of a physical activity intervention for managing restless legs syndrome in multiple sclerosis: Results of a pilot randomized controlled trial. Mult Scler Relat Disord. 2021 May;50:102836. doi: 10.1016/j.msard.2021.102836. Epub 2021 Feb 10.