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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Aerobic exercise

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35430
    • Recruiting
    • Dokuz Eylul University Hospital, MS Outpatient Clinic
    • Sub-Investigator: Ozge Ertekin, PhD
    • Contact: Serkan Ozakbas, MD; Phone Number: 4064 +902324124064; Email: serkan.ozakbas@gmail.com
    • Principal Investigator: Turhan Kahraman, PhD
    • Sub-Investigator: Asiye Tuba Ozdogar, MSc
    • Sub-Investigator: Seda Dastan
    • Sub-Investigator: Buse Ozcan Kahraman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Aerobic exercise	Behavioral: Aerobic exercise; Moderate aerobic exercise training

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restless Legs Syndrome Diagnostic Criteria	Diagnostic Criteria for Restless Legs Syndrome was developed by the Restless Legs Syndrome Working Group in 1995 and revised in 2003 and 2014. These criteria include; the need to move the legs due to uncomfortable or unpleasant sensations in the legs, the need for movement or disturbing sensations start or worsen at rest, the need for movement or disturbing sensations can be partially or totally relieved by movements such as walking or stretching, the need for movement or disturbing sensations may worsen at night or only occur in the evening or night, The aforementioned features cannot be considered only in relation to primary symptoms or other medical or behavioral conditions (e.g., myalgia, venous stasis, leg edema, leg cramps, habitual foot swing). Patients meeting all of the criteria are diagnosed with restless legs syndrome. The restless legs syndrome diagnosis will be confirmed by a neurologist.	At Baseline
Expanded Disability Status Scale	The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability	At Baseline

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Multiple Sclerosis; Sclerosis; Restless Legs Syndrome
• Other Study ID Numbers: 2022/12-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No