Efficacy of Project BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Behavioral Intervention (BIPAMS)
Participants will complete a 16-week behavioral intervention to increase physical activity levels.
Intervention: Behavioral Intervention (BIPAMS) (Behavioral)
Waitlist Control
Participants will have 16-weeks of no intervention or interaction.
Outcomes
Primary Outcomes
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Time Frame: Follow-Up
Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life over the previous week.Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms. This will be completed at the follow-up testing session.
Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Time Frame: Follow-Up
Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week. Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity. This will be completed at follow-up testing.
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Time Frame: Baseline
Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life over the previous week.Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms.This will be completed at the baseline testing session.
Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Time Frame: Baseline
Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week. Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity. This will be completed at baseline testing.
Secondary Outcomes
- Daytime Sleepiness as measured by the Epworth Sleepiness Scale(Follow-up)
- Sleep Quality as measured by accelerometry(Follow-up)
- Sleep Quality as measured by the Pittsburgh Sleep Quality Index(Follow-up)
- Sleep Quality as measured by the Pittsburgh Sleep Quality Index(Baseline)
- Sleep Quality as measured by accelerometry(Baseline)
- Daytime Sleepiness as measured by the Epworth Sleepiness Scale(Baseline)
Investigators
Robert W Motl
Professor
University of Alabama at Birmingham