Multiple SclerosisNCT04252053
The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis
A study testing Pilates Based Core Stabilization Training and Home based exercise in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Pilates Based Core Stabilization Training and Home based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2020to 3 Jan 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with MS according to McDonald's criteria
- Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
- No attacks during the last 3 months
- Being an ambulatory
- Volunteering to participate in the study
Who cannot join
- Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
- Doing regular sports
- Being involved in another physiotherapy and rehabilitation program related to MS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34147
About this study
Official title: The Effects of Pilates-Based Core Stabilization Training on Isokinetic Knee Strength and Postural Sway in People With Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's level of physical activity, mobility and quality of life, leading to further deterioration of the disorder. One of the most important problems that cause these problems in individuals with MS is reduced core stabilization. Decrease in core stabilization affects the quality of limb movements as well as trunk stability when considering the kinetic chain in the body. Pilates-based core stabilization training (PBCST) are a controlled exercise form used to improve the stabilization of trunk muscles. There are no studies on the effect of this training on lower extremity isokinetic muscle strength in individuals with MS. The aim of this study is to determine the effect of PBCST on lower extremity muscle strength, postural sway and kinetic chain in individuals with MS.
Read the detailed description
The study was planned as randomized controlled. Individuals included in the study wiil randomly allocate to the group receiving the supervised PBCST and the home exercise group. While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the home exercise group will perform the same exercises at home for the same time as the brochures prepared for them. The exercise program will show progression at 2-week intervals. A session will be held for both groups to teach the basic principles of pilates and will not be counted in the 8-week program. At the beginning and end of treatment, individuals will be evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality of life and functional capacity parameters. PBCST is thought to reduce postural sways and increase lower extremity muscle strength by increasing core stability with the effect of kinetic chain and increased stabilization.
- Conditions
- Multiple Sclerosis
- Being tested
- Pilates Based Core Stabilization Training, Home based exercise
- Keywords
- Multiple sclerosis, Pilates, Core stability, Isokinetic strength, Postural sway
- 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 Based Core Stabilization TrainingOther
Pilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles.
Home based exerciseOther
Home exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Pilates-Based Core Stability Training Group | Experimental | In order to detect the effects of pilates-based core stabilization training (PBCST) on isokinetic knee strength and postural sways, individuals with MS will receive pilates-based core stabilization training for 8 weeks and 2 days a week. One educational session will perform to teach basic principles of pilates based training. Individuals in this group will receive treatment at the clinic by physiotherapist supervision. All sessions will be individualized (not group training). Receives: Other: Pilates Based Core Stabilization Training |
| Home exercise group | Active comparator | The home exercise group will perform the same PBCST exercises at home during the same period (8 weeks, 2 days a week) as the brochures prepared for them. Individuals in this group will receive one educational session which includes basic principles of pilates and one session which includes two-week exercise program. Participants will be invited to the clinic every two weeks to ensure the progression of the exercises and the exercise program will be updated. Receives: Other: Home based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength
Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated at angular velocities of 30,60 and 90°/s.
Measured: 8 weeks
Postural sways
Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, tandem stance on firm and foam surface,
Measured: 8 weeks
Secondary outcomes (7)
Core strength
Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.
Measured: 8 weeks
Core endurance
Core endurance will be evaluated within the scope of core assessment. Trunk Flexor Endurance Test, Trunk Extensor Endurance Test, Trunk Lateral Endurance Test and Plank Test will be used in the evaluation of core endurance.
Measured: 8 weeks
Balance
Berg Balance Scale (BBS) will be used to evaluate balance. BBS is a test developed for functional evaluation of balance in adults. BBS consists of 14 general equilibrium activities that change the orientation of the body center of gravity relative to the support surface and the ability to maintain the static position during the reduction of the support surface. The highest score is 56. The decrease in the score indicates poorer balance.
Measured: 8 weeks
Mobility
Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.
Measured: 8 weeks
Fatigue
Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity.
Measured: 8 weeks
Quality of life
Multiple Sclerosis Quality of Life -54 (MSQOL-54) will be used to evaluate the effectiveness of the treatment on quality of life. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Measured: 8 weeks
Fall risk
Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start6 Feb 2020
- Primary completion3 Jan 2021
- Study completion3 Jan 2021
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Güngör, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252053
- Sponsor's protocol ID
- 59491012-604.01.02-
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pilates-Based Core Stabilization Training on Isokinetic Knee Strength and Postural Sway in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04252053
- Acronym / sponsor ID
- 59491012-604.01.02-
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Pilates, Core stability, Isokinetic strength, Postural sway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 5 Feb 2020 (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, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's level of physical activity, mobility and quality of life, leading to further deterioration of the disorder. One of the most important problems that cause these problems in individuals with MS is reduced core stabilization. Decrease in core stabilization affects the quality of limb movements as well as trunk stability when considering the kinetic chain in the body. Pilates-based core stabilization training (PBCST) are a controlled exercise form used to improve the stabilization of trunk muscles. There are no studies on the effect of this training on lower extremity isokinetic muscle strength in individuals with MS. The aim of this study is to determine the effect of PBCST on lower extremity muscle strength, postural sway and kinetic chain in individuals with MS.
Detailed description
The study was planned as randomized controlled. Individuals included in the study wiil randomly allocate to the group receiving the supervised PBCST and the home exercise group. While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the home exercise group will perform the same exercises at home for the same time as the brochures prepared for them. The exercise program will show progression at 2-week intervals. A session will be held for both groups to teach the basic principles of pilates and will not be counted in the 8-week program. At the beginning and end of treatment, individuals will be evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality of life and functional capacity parameters. PBCST is thought to reduce postural sways and increase lower extremity muscle strength by increasing core stability with the effect of kinetic chain and increased stabilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Pilates-Based Core Stability Training Group | Experimental | Other: Pilates Based Core Stabilization TrainingIn order to detect the effects of pilates-based core stabilization training (PBCST) on isokinetic knee strength and postural sways, individuals with MS will receive pilates-based core stabilization training for 8 weeks and 2 days a week. One educational session will perform to teach basic principles of pilates based training. Individuals in this group will receive treatment at the clinic by physiotherapist supervision. All sessions will be individualized (not group training). |
| Home exercise group | Active comparator | Other: Home based exerciseThe home exercise group will perform the same PBCST exercises at home during the same period (8 weeks, 2 days a week) as the brochures prepared for them. Individuals in this group will receive one educational session which includes basic principles of pilates and one session which includes two-week exercise program. Participants will be invited to the clinic every two weeks to ensure the progression of the exercises and the exercise program will be updated. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with MS according to McDonald's criteria
- Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
- No attacks during the last 3 months
- Being an ambulatory
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
- Doing regular sports
- Being involved in another physiotherapy and rehabilitation program related to MS
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 Based Core Stabilization TrainingPilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles. | Other | Supervised Pilates-Based Core Stability Training Group |
| Home based exerciseHome exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them. | Other | Home exercise group |
Primary outcome
Isokinetic strength
Time frame: 8 weeks
Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated at angular velocities of 30,60 and 90°/s.
Postural sways
Time frame: 8 weeks
Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, tandem stance on firm and foam surface,
7 secondary outcomes
Core strength
Time frame: 8 weeks
Core endurance
Time frame: 8 weeks
Balance
Time frame: 8 weeks
Mobility
Time frame: 8 weeks
Fatigue
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Fall risk
Time frame: 8 weeks
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 7 Jan 2021.
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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 Based Core Stabilization Training and Home based exercise in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa 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 5 inclusion and 3 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 7 Jan 2021. 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?
Isokinetic strength (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 7 Jan 2021.