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Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University Hospital, MS Outpatient ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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'.
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.
Pittsburgh Sleep Quality Index
Detect sleep disturbances or deficits.
Time Up and Go Test
Assessments will be performed with APDM Opals.
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.
Two-Minute Walk Test
Assessments will be performed with APDM Opals.
Estimated VO2 Max
Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.

Full Information

First Posted
May 30, 2022
Last Updated
June 2, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05402956
Brief Title
Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome
Official Title
Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Moderate aerobic exercise training
Primary Outcome Measure Information:
Title
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Description
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.
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Timed 25-Foot Walk
Description
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.
Time Frame
Change from Baseline at 12 weeks
Title
12-Item Multiple sclerosis walking scale
Description
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.
Time Frame
Change from Baseline at 12 weeks
Title
Epworth Sleepiness Scale
Description
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'.
Time Frame
Change from Baseline at 12 weeks
Title
Multiple Sclerosis International Quality of Life questionnaire
Description
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.
Time Frame
Change from Baseline at 12 weeks
Title
Pittsburgh Sleep Quality Index
Description
Detect sleep disturbances or deficits.
Time Frame
Change from Baseline at 12 weeks
Title
Time Up and Go Test
Description
Assessments will be performed with APDM Opals.
Time Frame
Change from Baseline at 12 weeks
Title
Six-Minute Walk Test
Description
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.
Time Frame
Change from Baseline at 12 weeks
Title
Two-Minute Walk Test
Description
Assessments will be performed with APDM Opals.
Time Frame
Change from Baseline at 12 weeks
Title
Estimated VO2 Max
Description
Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.
Time Frame
Change from Baseline at 12 weeks
Other Pre-specified Outcome Measures:
Title
Restless Legs Syndrome Diagnostic Criteria
Description
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.
Time Frame
At Baseline
Title
Expanded Disability Status Scale
Description
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
Time Frame
At Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dokuz Eylul University Hospital, MS Outpatient Clinic
City
Izmir
ZIP/Postal Code
35430
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Ozakbas, MD
Phone
+902324124064
Ext
4064
Email
serkan.ozakbas@gmail.com
First Name & Middle Initial & Last Name & Degree
Turhan Kahraman, PhD
First Name & Middle Initial & Last Name & Degree
Asiye Tuba Ozdogar, MSc
First Name & Middle Initial & Last Name & Degree
Ozge Ertekin, PhD
First Name & Middle Initial & Last Name & Degree
Seda Dastan
First Name & Middle Initial & Last Name & Degree
Buse Ozcan Kahraman, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome

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