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Clinical Pilates Training for Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates exercises
Home exercise program
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a diagnosis of definite MS
  • an age over than 18 years
  • walking independently 100 meters
  • willingness to participate in the study

Exclusion Criteria:

  • any neurological disease other than multiple sclerosis
  • relapse within 3 months
  • having orthopaedic disorders that could negatively affect gait and balance
  • having cardiopulmonary disorders
  • diagnosed cognitive and psychiatric problems
  • current and recent (within the last 6 months) participation in a core stability based exercise program

Sites / Locations

  • Dokuz Eylul University Hospital, MS Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates exercises group

Home exercise program group

Arm Description

Outcomes

Primary Outcome Measures

12-Item MS Walking Scale
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of multiple sclerosis on the individual's walking ability. The first 3 items are scored 1 - 3, and the other 9 items are scored 1 - 5. Scores on the 12 items are summed. The minimum score is 12 and the maximum score is 54. Higher the score, greater the impacted walking quality.

Secondary Outcome Measures

Six-Minute Walk Test
Timed 25-Foot Walk
Timed-Up and Go
Limits of Stability Test
Postural Stability Test
Fall Risk Index
Falls Efficacy Scale-International
Falls Efficacy Scale-International is a 16-item self-administered questionnaire designed to assess fear of falling. Items are scored a 1 if they are not at all concerned about falling going up to 4 if they are very concerned during each activity: 1 = Not at all concerned, 2 = Somewhat concerned, 3 = Fairly concerned, 4 = Very concerned. Item scores are summed to calculate a range of total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Activities-Specific Balance Confidence Scale
The Activities-Specific Balance Confidence Scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.
Curl-up Test
Maximum Inspiratory Pressure
Maximum Expiratory Pressure
Symbol Digit Modalities Test
California Verbal Learning Test-II
Brief Visuospatial Memory Test Revised
Expanded Disability Status Scale
The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Expanded Disability Status Scale steps 1.0 to 4.5 refer to people with multiple sclerosis who are able to walk without any aid. Expanded Disability Status Scale steps 5.0 to 9.5 are defined by the impairment to walking. Persons with multiple sclerosis with Expanded Disability Status Scale steps 6 and below will be participated in the study.

Full Information

First Posted
April 11, 2018
Last Updated
April 18, 2018
Sponsor
Dokuz Eylul University
Collaborators
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT03502772
Brief Title
Clinical Pilates Training for Persons With Multiple Sclerosis
Official Title
The Effects of Clinical Pilates Training on Walking, Balance, Fall Risk, Respiratory and Cognitive Functions in Persons With Multiple Sclerosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Izmir Katip Celebi University

4. Oversight

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

5. Study Description

Brief Summary
Multiple sclerosis (MS) is a chronic-progressive and neurodegenerative disease. Thus, exercise programs are needed to maintain and increase functional status of persons with MS (pwMS). Pilates exercises designed by physiotherapist can enhance participation and functionality in pwMS. The aim is to investigate the effects of a clinical Pilates training on balance, walking, fall risk, respiratory and cognitive functions in pwMS. Forty-two pwMS will be included in this randomized controlled trial. Participants will be divided into two groups with stratified randomization. Pilates exercises group (n=21) will receive therapy once a week for 8 weeks plus home exercise programme. The home exercise program group (n = 21) will be given written exercises that matched the aims of the Pilates exercises and the program compliance will be monitored by telephone calls once a week. The assessments will be done twice at the beginning and at the end of the treatment. The outcome measures include the Timed 25-Foot Walk (T25FW), Six-Minute Walk Test (6MWT), Timed Up and Go (TUG), TUG cognitive and manual forms, 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Curl-Up Test (CUT), Falls Efficacy Scale-International (FES-I), Activities-specific Balance Confidence (ABC) Scale, respiratory muscle strength assessment, Brief International Cognitive Assessment for MS (BICAMS).

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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates exercises group
Arm Type
Experimental
Arm Title
Home exercise program group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Intervention Description
Clinical Pilates training program will be given one session in a week for 8 weeks plus two days home exercise program. Group exercise sessions will be performed. The sessions will be supervised by a physiotherapist who is certified.
Intervention Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
written exercises that matched the aims of the Pilates exercises, 3 times per week for 8 weeks. These exercises reflect routine clinical practice (flexibility, strength, and balance exercises).
Primary Outcome Measure Information:
Title
12-Item MS Walking Scale
Description
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of multiple sclerosis on the individual's walking ability. The first 3 items are scored 1 - 3, and the other 9 items are scored 1 - 5. Scores on the 12 items are summed. The minimum score is 12 and the maximum score is 54. Higher the score, greater the impacted walking quality.
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Six-Minute Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Timed 25-Foot Walk
Time Frame
Change from Baseline at 8 weeks
Title
Timed-Up and Go
Time Frame
Change from Baseline at 8 weeks
Title
Limits of Stability Test
Time Frame
Change from Baseline at 8 weeks
Title
Postural Stability Test
Time Frame
Change from Baseline at 8 weeks
Title
Fall Risk Index
Time Frame
Change from Baseline at 8 weeks
Title
Falls Efficacy Scale-International
Description
Falls Efficacy Scale-International is a 16-item self-administered questionnaire designed to assess fear of falling. Items are scored a 1 if they are not at all concerned about falling going up to 4 if they are very concerned during each activity: 1 = Not at all concerned, 2 = Somewhat concerned, 3 = Fairly concerned, 4 = Very concerned. Item scores are summed to calculate a range of total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Time Frame
Change from Baseline at 8 weeks
Title
Activities-Specific Balance Confidence Scale
Description
The Activities-Specific Balance Confidence Scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.
Time Frame
Change from Baseline at 8 weeks
Title
Curl-up Test
Time Frame
Change from Baseline at 8 weeks
Title
Maximum Inspiratory Pressure
Time Frame
Change from Baseline at 8 weeks
Title
Maximum Expiratory Pressure
Time Frame
Change from Baseline at 8 weeks
Title
Symbol Digit Modalities Test
Time Frame
Change from Baseline at 8 weeks
Title
California Verbal Learning Test-II
Time Frame
Change from Baseline at 8 weeks
Title
Brief Visuospatial Memory Test Revised
Time Frame
Change from Baseline at 8 weeks
Title
Expanded Disability Status Scale
Description
The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Expanded Disability Status Scale steps 1.0 to 4.5 refer to people with multiple sclerosis who are able to walk without any aid. Expanded Disability Status Scale steps 5.0 to 9.5 are defined by the impairment to walking. Persons with multiple sclerosis with Expanded Disability Status Scale steps 6 and below will be participated in the study.
Time Frame
At Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of definite MS an age over than 18 years walking independently 100 meters willingness to participate in the study Exclusion Criteria: any neurological disease other than multiple sclerosis relapse within 3 months having orthopaedic disorders that could negatively affect gait and balance having cardiopulmonary disorders diagnosed cognitive and psychiatric problems current and recent (within the last 6 months) participation in a core stability based exercise program
Facility Information:
Facility Name
Dokuz Eylul University Hospital, MS Outpatient Clinic
City
İzmir
ZIP/Postal Code
35430
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Pilates Training for Persons With Multiple Sclerosis

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