Clinical trial NCT03502772: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2018-04-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 12-Item MS Walking Scale
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Six-Minute Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline at 8 weeks
measure: Timed-Up and Go
timeFrame: Change from Baseline at 8 weeks
measure: Limits of Stability Test
timeFrame: Change from Baseline at 8 weeks
measure: Postural Stability Test
timeFrame: Change from Baseline at 8 weeks
measure: Fall Risk Index
timeFrame: Change from Baseline at 8 weeks
measure: Falls Efficacy Scale-International
timeFrame: Change from Baseline at 8 weeks
measure: Activities-Specific Balance Confidence Scale
timeFrame: Change from Baseline at 8 weeks
measure: Curl-up Test
timeFrame: Change from Baseline at 8 weeks
measure: Maximum Inspiratory Pressure
timeFrame: Change from Baseline at 8 weeks
measure: Maximum Expiratory Pressure
timeFrame: Change from Baseline at 8 weeks
measure: Symbol Digit Modalities Test
timeFrame: Change from Baseline at 8 weeks
measure: California Verbal Learning Test-II
timeFrame: Change from Baseline at 8 weeks
measure: Brief Visuospatial Memory Test Revised
timeFrame: Change from Baseline at 8 weeks
measure: Expanded Disability Status Scale
timeFrame: At Baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
Study officials:
References: