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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03849001
• Other study ID #: IRB-300002951
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Psychomotor Agitation
• Restless Legs Syndrome
• Sclerosis
• Syndrome

Intervention

Behavioral:
• Exercise Conditions
Light Exercise
• Exercise Conditions
Moderate Exercise
• Exercise Conditions
Vigorous Exercise
• Exercise Conditions
Seated Rest

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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