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Completed

NCT Number: NCT03502772

Clinical Pilates Training for Persons With Multiple Sclerosis

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, 35430, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. 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

  1. Six-Minute Walk Test

    Time frame: Change from Baseline at 8 weeks

  2. Timed 25-Foot Walk

    Time frame: Change from Baseline at 8 weeks

  3. Timed-Up and Go

    Time frame: Change from Baseline at 8 weeks

  4. Limits of Stability Test

    Time frame: Change from Baseline at 8 weeks

  5. Postural Stability Test

    Time frame: Change from Baseline at 8 weeks

  6. Fall Risk Index

    Time frame: Change from Baseline at 8 weeks

  7. Falls Efficacy Scale-International

    Time frame: Change from Baseline at 8 weeks

    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.

  8. Activities-Specific Balance Confidence Scale

    Time frame: Change from Baseline at 8 weeks

    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.

  9. Curl-up Test

    Time frame: Change from Baseline at 8 weeks

  10. Maximum Inspiratory Pressure

    Time frame: Change from Baseline at 8 weeks

  11. Maximum Expiratory Pressure

    Time frame: Change from Baseline at 8 weeks

  12. Symbol Digit Modalities Test

    Time frame: Change from Baseline at 8 weeks

  13. California Verbal Learning Test-II

    Time frame: Change from Baseline at 8 weeks

  14. Brief Visuospatial Memory Test Revised

    Time frame: Change from Baseline at 8 weeks

  15. Expanded Disability Status Scale

    Time frame: At Baseline

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Izmir Katip Celebi University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2018
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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