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

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Multiple Sclerosis; Restless Legs Syndrome

Treatments: Behavioral: Exercise Conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT03849001

IRB-300002951

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Exercise Conditions

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Conditions

Behavioral: Exercise Conditions

Behavioral: Exercise Conditions

Behavioral: Exercise Conditions