Clinical Pilates Training for Persons With Multiple Sclerosis

NCT03502772 | Completed

• 1 other identifier: 3183-GOA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (2)

Pilates exercises group

EXPERIMENTAL

Other: Pilates exercises

Home exercise program group

ACTIVE COMPARATOR

Other: Home exercise program

Interventions

Pilates exercises 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.

Pilates exercises group

Home exercise program 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).

Home exercise program group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of definite MS
• an age over than 18 years
• walking independently 100 meters
• willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Izmir Katip Celebi University: collaborator

Study Sites (1)

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, 35430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: April 3, 2017
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

TU (1)