- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849001
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
November 26, 2019 updated by: Robert W Motl, University of Alabama at Birmingham
Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
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.
Study Overview
Status
Withdrawn
Conditions
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).
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 54 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Conditions
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.
|
Light Exercise
Moderate Exercise
Vigorous Exercise
Seated Rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time Frame: 10 minutes pre-exercise condition
|
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)
Time Frame: 10 minutes post-exercise condition
|
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)
Time Frame: 10 minutes pre-exercise condition
|
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)
Time Frame: 10 minutes post-exercise condition
|
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)
Time Frame: 10 minutes pre-exercise condition
|
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)
Time Frame: 10 minutes post-exercise condition
|
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)
Time Frame: 10 minutes pre-rest (Control) condition
|
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)
Time Frame: 10 minutes post-rest (Control) condition
|
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)
Time Frame: Baseline through screening
|
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)
Time Frame: Baseline through week 1
|
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)
Time Frame: week 1 through week 2
|
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)
Time Frame: week 2 through week 3
|
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)
Time Frame: week 3 through week 4
|
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)
Time Frame: week 4 through week 5
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert W Motl, PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
February 19, 2019
First Submitted That Met QC Criteria
February 20, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 26, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Multiple Sclerosis
- Sclerosis
- Syndrome
- Psychomotor Agitation
- Restless Legs Syndrome
Other Study ID Numbers
- IRB-300002951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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