Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome

Study Overview
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Brief Summary
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In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated.

Official Title
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Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A relapsing-remitting or secondary progressive type of multiple sclerosis, To be willing to participate in the study. Exclusion Criteria: Another neurological disorder, Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance, Diagnosed severe cognitive and/or psychiatric impairment, Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD Having cardiac disease such as hypertension that would be a contraindication to exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br> | Behavioral: Aerobic exercise<br>* Moderate aerobic exercise training<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Restless Legs Syndrome Study Group rating scale for restless legs syndrome | The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity. | Change from Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25-Foot Walk | The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average of the two completed trials. Higher time represents slower walking speed and more walking impairment. | Change from Baseline at 12 weeks | 
| 12-Item Multiple sclerosis walking scale | The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking. | Change from Baseline at 12 weeks | 
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. | Change from Baseline at 12 weeks | 
| Multiple Sclerosis International Quality of Life questionnaire | The Multiple Sclerosis International Quality of Life questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level. | Change from Baseline at 12 weeks | 
| Pittsburgh Sleep Quality Index | Detect sleep disturbances or deficits. | Change from Baseline at 12 weeks | 
| Time Up and Go Test | Assessments will be performed with APDM Opals. | Change from Baseline at 12 weeks | 
| Six-Minute Walk Test | The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity. | Change from Baseline at 12 weeks | 
| Two-Minute Walk Test | Assessments will be performed with APDM Opals. | Change from Baseline at 12 weeks | 
| Estimated VO2 Max | Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test. | Change from Baseline at 12 weeks |