Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome
Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2022
CompletedStudy Start
First participant enrolled
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 6, 2022
June 1, 2022
1.3 years
May 30, 2022
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (2)
Restless Legs Syndrome Diagnostic Criteria
At Baseline
Expanded Disability Status Scale
At Baseline
Study Arms (2)
Aerobic exercise
EXPERIMENTALControl
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- A relapsing-remitting or secondary progressive type of multiple sclerosis,
- To be willing to participate in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, 35430, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single (Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 30, 2022
First Posted
June 2, 2022
Study Start
May 30, 2022
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
June 6, 2022
Record last verified: 2022-06