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

NCT ID: NCT04061681

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-11-23

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Restless Legs Syndrome

Keywords

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of two conditions that will be occurring simultaneously.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral Intervention (BIPAMS)

Participants will complete a 16-week behavioral intervention to increase physical activity levels.

Group Type EXPERIMENTAL

Behavioral Intervention (BIPAMS)

Intervention Type BEHAVIORAL

This 16-week behavioral intervention teaches people the skills, techniques, and strategies based on Social Cognitive Theory of behavior change for modifying and self-regulating health behaviors, including physical activity. The behavioral intervention consists of two primary components, namely a dedicated Internet website and one-on-one video chats with a behavioral coach via SkypeTM.

Waitlist Control

Participants will have 16-weeks of no intervention or interaction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral Intervention (BIPAMS)

This 16-week behavioral intervention teaches people the skills, techniques, and strategies based on Social Cognitive Theory of behavior change for modifying and self-regulating health behaviors, including physical activity. The behavioral intervention consists of two primary components, namely a dedicated Internet website and one-on-one video chats with a behavioral coach via SkypeTM.

Intervention Type BEHAVIORAL

Other Intervention Names

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Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Robert W Motl

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert W Motl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33618120 (View on PubMed)

Other Identifiers

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IRB-300003877

Identifier Type: -

Identifier Source: org_study_id