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

Study Overview
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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.

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).

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

Conditions
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Multiple Sclerosis, Restless Legs Syndrome

Intervention / Treatment
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* Behavioral: Exercise Conditions
* Behavioral: Exercise Conditions
* Behavioral: Exercise Conditions
* Behavioral: Exercise Conditions


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Conditions<br>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. | Behavioral: Exercise Conditions<br>* Light Exercise<br>Behavioral: Exercise Conditions<br>* Moderate Exercise<br>Behavioral: Exercise Conditions<br>* Vigorous Exercise<br>Behavioral: Exercise Conditions<br>* Seated Rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the light exercise condition to capture pre-exercise RLS severity. | 10 minutes pre-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the light exercise condition to capture post-exercise RLS severity. | 10 minutes post-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the moderate exercise condition to capture pre-exercise RLS severity. | 10 minutes pre-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the moderate exercise condition to capture post-exercise RLS severity. | 10 minutes post-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the vigorous exercise condition to capture pre-exercise RLS severity. | 10 minutes pre-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the vigorous exercise condition to capture post-exercise RLS severity. | 10 minutes post-exercise condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the seated, quiet rest condition to capture pre-rest RLS severity. | 10 minutes pre-rest (Control) condition | 
| Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) | Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the seated, quiet rest condition to capture post-rest RLS severity. | 10 minutes post-rest (Control) condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | Baseline through screening | 
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | Baseline through week 1 | 
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | week 1 through week 2 | 
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | week 2 through week 3 | 
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | week 3 through week 4 | 
| Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS) | In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms. | week 4 through week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise