Sedentary LifestyleEarly Phase 1NCT02845544
Influence of Pilates-based Exercises on Postural Balance
A Early Phase 1 study testing Pilates-based exercises in people with Sedentary Lifestyle, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The study of the behavior of the mechanisms of body balance with a workout based on the Pilates method can facilitate the development of more accurate rehabilitation approaches. However, there is still little scientific information on its effects on the locomotor system and it's necessary to search for new methods to… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Pilates-based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Aug 2016
- Phase
- Early Phase 1
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary
- healthy
- with no pilates experience
Who cannot join
- Physically active
- with history of injuries and surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Kinesiology and Functional Evaluation in Federal University of Pernambuco
Recife, Pernambuco, 50.740-600
About this study
Official title: Influence of Pilates-based Exercises on Static and Dynamic Postural Balance of Sedentary Adults
The study of the behavior of the mechanisms of body balance with a workout based on the Pilates method can facilitate the development of more accurate rehabilitation approaches. However, there is still little scientific information on its effects on the locomotor system and it's necessary to search for new methods to evaluate its strategies more specifically. Thus, this study aims to determine whether an exercise program based on Pilates method has influence on the static and dynamic postural balance of sedentary adults. This is a randomized controlled trial, which will be developed with an initial sample of 20 subjects of both sexes, aged between 18 and 30 years, divided into two groups: a control group and an experimental group. Participants with physical activity time up to 150 minutes per week will be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those who have no experience with the Pilates method. In the experimental group a workout program will be done for 6 weeks with individual classes including exercises based on the Pilates method, during 1-hour, twice a week. Assessments will be made prior and after the training program with anamnesis, anthropometric measurements and also the Balance Error Scoring System and the Star Excursion Balance Test Y to assess postural balance. During the tests and training program exercises the muscle activity of paraspinals and transversus abdominis will be analyzed using surface electromyography (sEMG), and body mass center displacement will be measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will be entered in a spreadsheet and statistically tested with SPSS software. The tests will include the comparison of means, association, correlation and effect size, which will be chosen according to the distribution of the data and will use the 5% significance level for all tests.
- Conditions
- Sedentary Lifestyle
- Being tested
- Pilates-based exercises
- Keywords
- Postural Balance
- 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-based exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - Pilates | Experimental | A Pilates-based exercises program of 6 weeks' duration Receives: Other: Pilates-based exercises |
| Control group - no exercises | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and dynamic postural balance with body mass displacement tracking
Postural balance will be assessed during standing position and walking while wearing a triaxial accelerometer for the body mass displacement tracking
Measured: up to 6 weeks
Secondary outcomes (1)
Surface Electromyography of the abdominal and low-back muscles
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionAug 2016
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla Alencar de Oliveira Morais, Universidade Federal de Pernambuco
- Investigators
- Marco AB Rodrigues, Ph.D., Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845544
- Sponsor's protocol ID
- PAOM0012016
- Status last verified
- Sep 2016
- First submitted
- 3 May 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pilates-based Exercises on Static and Dynamic Postural Balance of Sedentary Adults
- ClinicalTrials.gov ID
- NCT02845544
- Acronym / sponsor ID
- PAOM0012016
- Conditions
- Sedentary Lifestyle
- Keywords
- Postural Balance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The study of the behavior of the mechanisms of body balance with a workout based on the Pilates method can facilitate the development of more accurate rehabilitation approaches. However, there is still little scientific information on its effects on the locomotor system and it's necessary to search for new methods to evaluate its strategies more specifically. Thus, this study aims to determine whether an exercise program based on Pilates method has influence on the static and dynamic postural balance of sedentary adults. This is a randomized controlled trial, which will be developed with an initial sample of 20 subjects of both sexes, aged between 18 and 30 years, divided into two groups: a control group and an experimental group. Participants with physical activity time up to 150 minutes per week will be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those who have no experience with the Pilates method. In the experimental group a workout program will be done for 6 weeks with individual classes including exercises based on the Pilates method, during 1-hour, twice a week. Assessments will be made prior and after the training program with anamnesis, anthropometric measurements and also the Balance Error Scoring System and the Star Excursion Balance Test Y to assess postural balance. During the tests and training program exercises the muscle activity of paraspinals and transversus abdominis will be analyzed using surface electromyography (sEMG), and body mass center displacement will be measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will be entered in a spreadsheet and statistically tested with SPSS software. The tests will include the comparison of means, association, correlation and effect size, which will be chosen according to the distribution of the data and will use the 5% significance level for all tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group - Pilates | Experimental | Other: Pilates-based exercisesA Pilates-based exercises program of 6 weeks' duration |
| Control group - no exercises | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary
- healthy
- with no pilates experience
Key exclusion criteria (2 listed)
- Physically active
- with history of injuries and surgery
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 exercises | Other | Experimental group - Pilates |
Primary outcome
Static and dynamic postural balance with body mass displacement tracking
Time frame: up to 6 weeks
Postural balance will be assessed during standing position and walking while wearing a triaxial accelerometer for the body mass displacement tracking
1 secondary outcome
Surface Electromyography of the abdominal and low-back muscles
Time frame: up to 6 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 8 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Sedentary Lifestyle
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
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.
Marco AB Rodrigues, Ph.D. study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pilates-based exercises in people with Sedentary Lifestyle, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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: finished, as of the sponsor's last update on 8 Sep 2016. 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 Brazil. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Static and dynamic postural balance with body mass displacement tracking (time frame: up to 6 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 8 Sep 2016.