Multiple SclerosisNCT03502772
Clinical Pilates Training for Persons With Multiple Sclerosis
A study testing Pilates exercises and Home exercise program in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Pilates exercises and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2017to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of definite MS
- an age over than 18 years
- walking independently 100 meters
- willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, 35430
About this study
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
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
- Being tested
- Pilates exercises, Home exercise program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
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 programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises group | Experimental | Not described Receives: Other: Pilates exercises |
| Home exercise program group | Active comparator | Not described Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (15)
Six-Minute Walk Test
Measured: Change from Baseline at 8 weeks
Timed 25-Foot Walk
Measured: Change from Baseline at 8 weeks
Timed-Up and Go
Measured: Change from Baseline at 8 weeks
Limits of Stability Test
Measured: Change from Baseline at 8 weeks
Postural Stability Test
Measured: Change from Baseline at 8 weeks
Fall Risk Index
Measured: Change from Baseline at 8 weeks
Falls Efficacy Scale-International
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.
Measured: Change from Baseline at 8 weeks
Activities-Specific Balance Confidence Scale
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.
Measured: Change from Baseline at 8 weeks
Curl-up Test
Measured: Change from Baseline at 8 weeks
Maximum Inspiratory Pressure
Measured: Change from Baseline at 8 weeks
Maximum Expiratory Pressure
Measured: Change from Baseline at 8 weeks
Symbol Digit Modalities Test
Measured: Change from Baseline at 8 weeks
California Verbal Learning Test-II
Measured: Change from Baseline at 8 weeks
Brief Visuospatial Memory Test Revised
Measured: Change from Baseline at 8 weeks
Expanded Disability Status Scale
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.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start3 Apr 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Responsible party
- Principal investigator, Turhan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502772
- Sponsor's protocol ID
- 3183-GOA
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03502772
- Acronym / sponsor ID
- 3183-GOA
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises group | Experimental | Other: Pilates exercises |
| Home exercise program group | Active comparator | Other: Home exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of definite MS
- an age over than 18 years
- walking independently 100 meters
- willingness to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesClinical 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. | Other | Pilates exercises group |
| Home exercise programwritten 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). | Other | Home exercise program group |
Primary outcome
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.
15 secondary outcomes
Six-Minute Walk Test
Time frame: Change from Baseline at 8 weeks
Timed 25-Foot Walk
Time frame: Change from Baseline at 8 weeks
Timed-Up and Go
Time frame: Change from Baseline at 8 weeks
Limits of Stability Test
Time frame: Change from Baseline at 8 weeks
Postural Stability Test
Time frame: Change from Baseline at 8 weeks
Fall Risk Index
Time frame: Change from Baseline at 8 weeks
Falls Efficacy Scale-International
Time frame: Change from Baseline at 8 weeks
Activities-Specific Balance Confidence Scale
Time frame: Change from Baseline at 8 weeks
Curl-up Test
Time frame: Change from Baseline at 8 weeks
Maximum Inspiratory Pressure
Time frame: Change from Baseline at 8 weeks
Maximum Expiratory Pressure
Time frame: Change from Baseline at 8 weeks
Symbol Digit Modalities Test
Time frame: Change from Baseline at 8 weeks
California Verbal Learning Test-II
Time frame: Change from Baseline at 8 weeks
Brief Visuospatial Memory Test Revised
Time frame: Change from Baseline at 8 weeks
Expanded Disability Status Scale
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
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A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
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RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
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RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Home exercise program in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Item MS Walking Scale (time frame: Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.