Sedentary LifestyleNCT03536273
The Effect of Pilates Group Exercise Program
A study testing Pilates Group Exercises in people with Sedentary Lifestyle, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
INTRODUCTION AND AIM: The Pilates exercises were introduced by Joseph Pilates in the 1920s, originally called 'centering'. These exercises work on 6 simple principles with or without special equipment. These principles are; centering, concentration, tenderness, flow and respiration. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Pilates Group Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2018to 30 Jul 2018
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have not had a surgical operation involving the musculoskeletal system in the past six months.
- Not to have a systemic disease leading preventing from exercise.
- Not having had any exercise in the last 3 months.
Who cannot join
- Do not want to continue exercises.
- To feel pain, discomfort during tests.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emre Serdar Atalay
Istanbul, 34815
Guler Atalay
About this study
Official title: The Effect of Pilates Group Exercise Program on Functional Movement Scores, Posture, Depression and Quality of Life in Sedentary Women
INTRODUCTION AND AIM: The Pilates exercises were introduced by Joseph Pilates in the 1920s, originally called 'centering'. These exercises work on 6 simple principles with or without special equipment. These principles are; centering, concentration, tenderness, flow and respiration. (Yamato et al., 2016) Functional movement analysis is a screening system developed by physiotherapist Gray Cook. Functional deficits of the person are detected by 7 different movements (Cook, Burton and Hoogenboom 2006a, Cook, Burton and Hoogenboom 2006b). In a single study they compared in the literature that assessed the effect of Pilates exercises on functional movement, this activity was explored on recreational runners (Laws, Williams and Wilson 2017). The aim of this study was to investigate the effect of 12-week pilates group exercise training on functional movement scores in sedentary women. Secondarily; posture, depression level and quality of life will be evaluated.
MATERIAL-METHODS: This study has been reviewed by Ethics Committee of Non-Interventional Researches of the University of Medipol in Istanbul and its ethical conformity has been approved. (10840098-604.01.01-E.45484). Participants were informed of the voluntary consent form and signed the consent form.
Read more
Participants 20 sedentary women were included in the study between 30-50 years of age.
Evaluations
Demographic information (Age, Occupation, Height, Weight) of the persons will be recorded.Functional Movement Analysis; Postural Analysis, Depression level; Health Related Life quality will be recorded.
Application Pilates exercises will be applied by a qualified physiotherapist with an internationally recognized certificate on the subject. Participants will be asked to come up with suitable outfits. the exercise room will be set at the ideal temperature and well ventilated. The exercises to be done in the form of group exercises will be started with an entry level, and the level of the exercises will be increased appropriately in the following weeks. Each group will consist of no more than 10 people and the exercises will continue for three sessions per week for 12 weeks. The evaluations will be repeated before exercise, at the end of 12 weeks of exercise and after 3 months from finish of the exercise period.
- Conditions
- Sedentary Lifestyle
- Being tested
- Pilates Group Exercises
- Keywords
- sedentary, pilates exercises, functional movement screen, posture, quality of life
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Group ExercisesOther
For 12 weeks, 3 repetitions per week
| Study group | Role | What they receive |
|---|---|---|
| Functional Movement Screen | Experimental | Not described Receives: Other: Pilates Group Exercises |
| Posture Analysis | Experimental | Not described Receives: Other: Pilates Group Exercises |
| Depression Level | Experimental | Not described Receives: Other: Pilates Group Exercises |
| Quality of Life | Experimental | Not described Receives: Other: Pilates Group Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Movement Screen Total Score
7 subtests
Measured: 20 minutes
Secondary outcomes (3)
New York Posture Analysis Score
Observational scale filled by physiotherapist
Measured: 10 min
Beck Depression Scale
Scale to be marked by the participant
Measured: 5 min
Short Form 36 Quality of Life Assessment
Scale to be marked by the participant
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start3 Jan 2018
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Serdar Vayvay, Medipol University
- Investigators
- Emre S Atalay, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536273
- Sponsor's protocol ID
- 10840098-604.01.01-E.45484
- Status last verified
- May 2018
- First submitted
- 14 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates Group Exercise Program on Functional Movement Scores, Posture, Depression and Quality of Life in Sedentary Women
- ClinicalTrials.gov ID
- NCT03536273
- Acronym / sponsor ID
- 10840098-604.01.01-E.45484
- Conditions
- Sedentary Lifestyle
- Keywords
- sedentary, pilates exercises, functional movement screen, posture, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 24 May 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.
INTRODUCTION AND AIM: The Pilates exercises were introduced by Joseph Pilates in the 1920s, originally called 'centering'. These exercises work on 6 simple principles with or without special equipment. These principles are; centering, concentration, tenderness, flow and respiration. (Yamato et al., 2016) Functional movement analysis is a screening system developed by physiotherapist Gray Cook. Functional deficits of the person are detected by 7 different movements (Cook, Burton and Hoogenboom 2006a, Cook, Burton and Hoogenboom 2006b). In a single study they compared in the literature that assessed the effect of Pilates exercises on functional movement, this activity was explored on recreational runners (Laws, Williams and Wilson 2017). The aim of this study was to investigate the effect of 12-week pilates group exercise training on functional movement scores in sedentary women. Secondarily; posture, depression level and quality of life will be evaluated.
MATERIAL-METHODS: This study has been reviewed by Ethics Committee of Non-Interventional Researches of the University of Medipol in Istanbul and its ethical conformity has been approved. (10840098-604.01.01-E.45484). Participants were informed of the voluntary consent form and signed the consent form.
Participants 20 sedentary women were included in the study between 30-50 years of age.
Evaluations
Demographic information (Age, Occupation, Height, Weight) of the persons will be recorded.Functional Movement Analysis; Postural Analysis, Depression level; Health Related Life quality will be recorded.
Application Pilates exercises will be applied by a qualified physiotherapist with an internationally recognized certificate on the subject. Participants will be asked to come up with suitable outfits. the exercise room will be set at the ideal temperature and well ventilated. The exercises to be done in the form of group exercises will be started with an entry level, and the level of the exercises will be increased appropriately in the following weeks. Each group will consist of no more than 10 people and the exercises will continue for three sessions per week for 12 weeks. The evaluations will be repeated before exercise, at the end of 12 weeks of exercise and after 3 months from finish of the exercise period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functional Movement Screen | Experimental | Other: Pilates Group Exercises |
| Posture Analysis | Experimental | Other: Pilates Group Exercises |
| Depression Level | Experimental | Other: Pilates Group Exercises |
| Quality of Life | Experimental | Other: Pilates Group Exercises |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have not had a surgical operation involving the musculoskeletal system in the past six months.
- Not to have a systemic disease leading preventing from exercise.
- Not having had any exercise in the last 3 months.
Key exclusion criteria (2 listed)
- Do not want to continue exercises.
- To feel pain, discomfort during tests.
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 Group ExercisesFor 12 weeks, 3 repetitions per week | Other | Depression Level, Functional Movement Screen, Posture Analysis, Quality of Life |
Primary outcome
Functional Movement Screen Total Score
Time frame: 20 minutes
7 subtests
3 secondary outcomes
New York Posture Analysis Score
Time frame: 10 min
Beck Depression Scale
Time frame: 5 min
Short Form 36 Quality of Life Assessment
Time frame: 10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: No
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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.
Emre S Atalay, PhD principal investigator
Saglik Bilimleri Universitesi
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 Group Exercises in people with Sedentary Lifestyle, run by Medipol 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emre S Atalay, PhD (+905444051824, ptserdar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Movement Screen Total Score (time frame: 20 minutes). 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 24 May 2018.