Clinical Pilates Training for Persons With Multiple Sclerosis

The Effects of Clinical Pilates Training on Walking, Balance, Fall Risk, Respiratory and Cognitive Functions in Persons With Multiple Sclerosis: A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Pilates exercises; Other: Home exercise program

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35430
    • Dokuz Eylul University Hospital, MS Outpatient Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates exercises group	Other: Pilates exercises; 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.
Active Comparator: Home exercise program group	Other: Home exercise program; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walk Test		Change from Baseline at 8 weeks
Timed 25-Foot Walk		Change from Baseline at 8 weeks
Timed-Up and Go		Change from Baseline at 8 weeks
Limits of Stability Test		Change from Baseline at 8 weeks
Postural Stability Test		Change from Baseline at 8 weeks
Fall Risk Index		Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
Curl-up Test		Change from Baseline at 8 weeks
Maximum Inspiratory Pressure		Change from Baseline at 8 weeks
Maximum Expiratory Pressure		Change from Baseline at 8 weeks
Symbol Digit Modalities Test		Change from Baseline at 8 weeks
California Verbal Learning Test-II		Change from Baseline at 8 weeks
Brief Visuospatial Memory Test Revised		Change from Baseline at 8 weeks
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.	At Baseline

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): December 29, 2017

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 3183-GOA

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