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Clinical Trials/NCT05402956
NCT05402956
Unknown
Not Applicable

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

Dokuz Eylul University1 site in 1 country30 target enrollmentMay 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Dokuz Eylul University
Enrollment
30
Locations
1
Primary Endpoint
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
May 30, 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Turhan Kahraman

PhD

Dokuz Eylul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

International Restless Legs Syndrome Study Group rating scale for restless legs syndrome

Time Frame: Change from Baseline at 12 weeks

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.

Secondary Outcomes

  • Timed 25-Foot Walk(Change from Baseline at 12 weeks)
  • 12-Item Multiple sclerosis walking scale(Change from Baseline at 12 weeks)
  • Epworth Sleepiness Scale(Change from Baseline at 12 weeks)
  • Multiple Sclerosis International Quality of Life questionnaire(Change from Baseline at 12 weeks)
  • Pittsburgh Sleep Quality Index(Change from Baseline at 12 weeks)
  • Time Up and Go Test(Change from Baseline at 12 weeks)
  • Six-Minute Walk Test(Change from Baseline at 12 weeks)
  • Two-Minute Walk Test(Change from Baseline at 12 weeks)
  • Estimated VO2 Max(Change from Baseline at 12 weeks)

Study Sites (1)

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