Clinical Pilates Training for Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502772
• Other study ID #: 3183-GOA
• Status: Completed
• Phase: N/A
• First received: April 11, 2018
• Last updated: April 18, 2018
• Start date: April 3, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: April 2018
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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).

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University Hospital, MS Outpatient Clinic	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

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