Clinical trial NCT03849001: Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
Official title: Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Restless Legs Syndrome
Keywords: Exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes pre-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes post-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes pre-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes post-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes pre-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes post-exercise condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes pre-rest (Control) condition
measure: Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
timeFrame: 10 minutes post-rest (Control) condition
Secondary outcomes:
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: Baseline through screening
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: Baseline through week 1
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: week 1 through week 2
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: week 2 through week 3
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: week 3 through week 4
measure: Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
timeFrame: week 4 through week 5
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Robert W Motl, PhD
role: PRINCIPAL_INVESTIGATOR
References: