Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Exercise Conditions | Light Exercise |
| BEHAVIORAL | Exercise Conditions | Moderate Exercise |
| BEHAVIORAL | Exercise Conditions | Vigorous Exercise |
| BEHAVIORAL | Exercise Conditions | Seated 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.