Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Aerobic exercise

• Registration Number: NCT05402956
• Lead Sponsor: Dokuz Eylul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-05-30
• Status Verified: 2022-06
• Study First Posted: 2022-06-02
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise	Aerobic exercise	-

Primary Outcome Measures

Name	Time	Method
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome	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 Outcome Measures

Name	Time	Method
Time Up and Go Test	Change from Baseline at 12 weeks	Assessments will be performed with APDM Opals.
Timed 25-Foot Walk	Change from Baseline at 12 weeks	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.
12-Item Multiple sclerosis walking scale	Change from Baseline at 12 weeks	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.
Epworth Sleepiness Scale	Change from Baseline at 12 weeks	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'.
Multiple Sclerosis International Quality of Life questionnaire	Change from Baseline at 12 weeks	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.
Pittsburgh Sleep Quality Index	Change from Baseline at 12 weeks	Detect sleep disturbances or deficits.
Six-Minute Walk Test	Change from Baseline at 12 weeks	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.
Two-Minute Walk Test	Change from Baseline at 12 weeks	Assessments will be performed with APDM Opals.
Estimated VO2 Max	Change from Baseline at 12 weeks	Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.

Trial Locations

Locations (1)

Dokuz Eylul University Hospital, MS Outpatient Clinic; 🇹🇷 Izmir, Turkey