Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-09-01

Brief Summary

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The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.

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Detailed Description

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The aim of this study is to evaluate the impact of acute leg cycling conditions at three different intensities (i.e., light, moderate, and vigorous) versus a control condition (i.e., quiet rest) on symptoms of RLS in persons with MS. This study involves a within-subjects, repeated measures design that includes a proposed sample of 24 participants diagnosed with both MS and RLS. Participants will complete four sessions with supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks. The order of the three conditions will be randomized and counterbalanced and include: (1) leg cycling with no resistance (i.e., light), (2) leg cycling at moderate intensity, (3) leg cycling at vigorous intensity, and (4) seated, quiet rest (i.e., control condition). The primary study outcome includes the objective measure of RLS severity using the Suggested Immobilization Test (SIT) that will be administered immediately before and immediately after each condition (i.e., light, moderate, vigorous, and quiet rest).

Conditions

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Multiple Sclerosis Restless Legs Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Conditions

Participants will undergo four "Exercise Conditions" (i.e., light intensity leg cycling, moderate intensity leg cycling, vigorous intensity leg cycling, and a seated, quiet rest) in a randomized, counterbalanced order.

Group Type EXPERIMENTAL

Exercise Conditions

Intervention Type BEHAVIORAL

Light Exercise

Exercise Conditions

Intervention Type BEHAVIORAL

Moderate Exercise

Exercise Conditions

Intervention Type BEHAVIORAL

Vigorous Exercise

Exercise Conditions

Intervention Type BEHAVIORAL

Seated Rest

Interventions

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Exercise Conditions

Light Exercise

Intervention Type BEHAVIORAL

Exercise Conditions

Moderate Exercise

Intervention Type BEHAVIORAL

Exercise Conditions

Vigorous Exercise

Intervention Type BEHAVIORAL

Exercise Conditions

Seated Rest

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-54 years of age
* Diagnosis of multiple sclerosis
* Has not experienced a relapse in the last 30 days
* Positive screening for restless legs syndrome
* Restless legs syndrome severity of moderate or greater
* Ambulatory with or without an aide

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No