Impact of Acute Leg Cycling at Various Intensities on RLS Severity in
Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Study halted prematurely, prior to enrollment of first participant
What was tested
Treatment tested
- Exercise Conditions
What it measured
Main measures
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
10 minutes pre-exercise condition
Physical functionBladder, bowel and sexual functionRestless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
10 minutes post-exercise condition
Physical functionBladder, bowel and sexual functionRestless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
10 minutes pre-rest (Control) condition
Bladder, bowel and sexual functionRestless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
10 minutes post-rest (Control) condition
Bladder, bowel and sexual function
Other measures (6)
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Baseline through screening
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Baseline through week 1
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
week 1 through week 2
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
week 2 through week 3
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
week 3 through week 4
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
week 4 through week 5
Who could take part
MS (type not specified) · 18 to 54
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Sept 2019
Main results due
Sept 2019
Finished
Sept 2019