AgingNCT02636296
The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women
A study testing Pilates in people with Aging, run by University of Sao Paulo.
Trial summary
The purpose of the present study was to investigate the effects of 12-week Pilates-inspired exercise on functional performance in community-dwelling older women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2012
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good health based on clinical examination (doctor's certificate)
- good functional capacity(physical examination)
Who cannot join
- current smokers
- obese (BMI >30 Kg/cm2)
- musculoskeletal limitations
- neurologic diseases
- cardiovascular diseases
- condition that contraindicated exercise
- regularly engaged in other physical conditioning program (>2x/week and/or >150min/week)
About this study
Official title: The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women: a Randomized Study
The purpose of the present study was to investigate the effects of 12-week Pilates-inspired exercise on functional performance in community-dwelling older women.
Read the detailed description
Pilates is an exercise system developed over 70 years ago that has been recently received attention due to its beneficial effects on postural stability, coordination, muscle strength and flexibility. The studies published involving Pilates were very different among them regarding intervention period (5, 8, 12 and 24 weeks), frequency (2 and 3 sessions/week) and exercises (mat, mat with accessories, apparatus and others combinations), making meaningful comparison difficult. Furthermore, other important physical features to maintain an independent life at older age, such as cardiorespiratory fitness, were accessed in few studies. So, the effective benefits of Pilates method on physical fitness of community-dwelling older people remain unclear.
- Conditions
- Aging
- Being tested
- Pilates, Control
- Keywords
- Pilates method, elderly, postural balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
The Pilates program was conducted twice weekly, 60 minutes/session, for twelve consecutive weeks by a certified Pilates Instructor.
ControlOther
The control group did not receive the Pilates training program and were instructed to maintain their currently activities during the twelve-week follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | Group received 12 week of inspired-Pilates intervention (2 days/week, 60 minutes duration). Receives: Other: Pilates |
| Control | Other | Control group was oriented to maintain the habitual activities during 12 weeks Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical fitness
In this study, physical fitness includes strength, balance and aerobic resistance.
Measured: changes from baseline physical fitness at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Ruth Caldeira de Melo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636296
- Sponsor's protocol ID
- HI017/2010
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women: a Randomized Study
- ClinicalTrials.gov ID
- NCT02636296
- Acronym / sponsor ID
- HI017/2010
- Conditions
- Aging
- Keywords
- Pilates method, elderly, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Dec 2015 (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 purpose of the present study was to investigate the effects of 12-week Pilates-inspired exercise on functional performance in community-dwelling older women.
Detailed description
Pilates is an exercise system developed over 70 years ago that has been recently received attention due to its beneficial effects on postural stability, coordination, muscle strength and flexibility. The studies published involving Pilates were very different among them regarding intervention period (5, 8, 12 and 24 weeks), frequency (2 and 3 sessions/week) and exercises (mat, mat with accessories, apparatus and others combinations), making meaningful comparison difficult. Furthermore, other important physical features to maintain an independent life at older age, such as cardiorespiratory fitness, were accessed in few studies. So, the effective benefits of Pilates method on physical fitness of community-dwelling older people remain unclear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: PilatesGroup received 12 week of inspired-Pilates intervention (2 days/week, 60 minutes duration). |
| Control | Other | Other: ControlControl group was oriented to maintain the habitual activities during 12 weeks |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- good health based on clinical examination (doctor's certificate)
- good functional capacity(physical examination)
Key exclusion criteria (7 listed)
- current smokers
- obese (BMI >30 Kg/cm2)
- musculoskeletal limitations
- neurologic diseases
- cardiovascular diseases
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 |
|---|---|---|
| PilatesThe Pilates program was conducted twice weekly, 60 minutes/session, for twelve consecutive weeks by a certified Pilates Instructor. | Other | Pilates |
| ControlThe control group did not receive the Pilates training program and were instructed to maintain their currently activities during the twelve-week follow-up period. | Other | Control |
Primary outcome
physical fitness
Time frame: changes from baseline physical fitness at 12 weeks
In this study, physical fitness includes strength, balance and aerobic resistance.
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 21 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Aging, run by University of Sao Paulo.
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 2 inclusion and 7 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
physical fitness (time frame: changes from baseline physical fitness at 12 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 21 Dec 2015.