The Effects of Clinical Pilates Training on Walking, Balance, Fall Risk, Respiratory and Cognitive Functions in Persons With Multiple Sclerosis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- 12-Item MS Walking Scale
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pilates exercises group
Intervention: Pilates exercises (Other)
Home exercise program group
Intervention: Home exercise program (Other)
Outcomes
Primary Outcomes
12-Item MS Walking Scale
Time Frame: Change from Baseline at 8 weeks
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 Outcomes
- Six-Minute Walk Test(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)
- Maximum Inspiratory Pressure(Change from Baseline at 8 weeks)
- Timed-Up and Go(Change from Baseline at 8 weeks)
- Falls Efficacy Scale-International(Change from Baseline at 8 weeks)
- Curl-up Test(Change from Baseline at 8 weeks)
- Expanded Disability Status Scale(At Baseline)
- Fall Risk Index(Change from Baseline at 8 weeks)
- Activities-Specific Balance Confidence Scale(Change from Baseline at 8 weeks)
- Brief Visuospatial Memory Test Revised(Change from Baseline at 8 weeks)
- Timed 25-Foot Walk(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)
Investigators
Turhan Kahraman
Principal Investigator
Dokuz Eylul University