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

NCT04061681 | Completed

• 1 other identifier: IRB-300003877
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Restless Legs Syndrome

Keywords

Physical Activity

Outcome Measures

Primary Outcomes (4)

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale

  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.

  Baseline

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale

  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.

  Follow-Up

• Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire

  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.

  Baseline

• Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire

  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.

  Follow-Up

Secondary Outcomes (6)

• Sleep Quality as measured by the Pittsburgh Sleep Quality Index

  Baseline

• Sleep Quality as measured by the Pittsburgh Sleep Quality Index

  Follow-up

• Sleep Quality as measured by accelerometry

  Baseline

• Sleep Quality as measured by accelerometry

  Follow-up

• Daytime Sleepiness as measured by the Epworth Sleepiness Scale

  Baseline

Study Arms (2)

Behavioral Intervention (BIPAMS)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention (BIPAMS)

Waitlist Control

NO INTERVENTION

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

Interventions

Behavioral Intervention (BIPAMS) 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.

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

Behavioral Intervention (BIPAMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 33618120 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Restless Legs Syndrome; Motor Activity

Interventions

Behavior Therapy; Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robert W Motl, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to one of two conditions that will be occurring simultaneously.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: January 1, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)