Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03849001

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

Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
18 Years – 54 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise ConditionsLight Exercise
BEHAVIORALExercise ConditionsModerate Exercise
BEHAVIORALExercise ConditionsVigorous Exercise
BEHAVIORALExercise ConditionsSeated Rest

Timeline

Start date
2019-09-01
Primary completion
2019-09-01
Completion
2019-09-01
First posted
2019-02-21
Last updated
2019-12-02

Source: ClinicalTrials.gov record NCT03849001. Inclusion in this directory is not an endorsement.

Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS (NCT03849001) · Clinical Trials Directory