Clinical Pilates Training for Persons With Multiple Sclerosis

NCT ID: NCT03502772

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2017-12-29

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilates exercises group

Group Type: EXPERIMENTAL

Pilates exercises

Intervention Type: OTHER

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 group

Group Type: ACTIVE_COMPARATOR

Home exercise program

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Turhan Kahraman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

3183-GOA

Identifier Type: -

Identifier Source: org_study_id