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

• ClinicalTrials.gov Identifier: NCT03849001
• Recruitment Status: Withdrawn
• First Posted: February 21, 2019
• Last Update Posted: December 2, 2019
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Robert W Motl, University of Alabama at Birmingham

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis; Restless Legs Syndrome	Behavioral: Exercise Conditions	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
• Actual Study Start Date: September 1, 2019
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: September 1, 2019

Arms and Interventions

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.	Behavioral: Exercise Conditions; Light Exercise; Behavioral: Exercise Conditions; Moderate Exercise; Behavioral: Exercise Conditions; Vigorous Exercise; Behavioral: Exercise Conditions; Seated Rest

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 54 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Robert W Motl, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Robert W Motl, Primary Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03849001
• Other Study ID Numbers: IRB-300002951
• First Posted: February 21, 2019
• Last Update Posted: December 2, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert W Motl, University of Alabama at Birmingham:

Exercise

Additional relevant MeSH terms:

Multiple Sclerosis; Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Sclerosis; Disease; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders