ExerciseNCT01841385
Effects of Pilates on Respiratory Mechanics
A study testing Pilates method in people with Exercise, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the influence of a fitness program from the application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in women. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Pilates method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Aug 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) ≤ 29 kg/m2
- not physically active on a regular basis, ie, sedentary lifestyle with scores up to eight, according to Baecke et al.
- nonsmokers
- non-alcoholic
- without any abnormalities in the cardiovascular, respiratory or neuromuscular
Who cannot join
- disabling diseases
- gestation
- puerperium there is less than a year
- inability to understand the tests and exercises proposed
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metodista de Piracicaba (UNIMEP)
Piracicaba, São Paulo
About this study
Official title: Influence of Application of the Pilates Method on Pulmonary Function, Thoracic Mobility and Respiratory Muscle Strength
The aim of this study was to evaluate the influence of a fitness program from the application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in women.
Read the detailed description
Study in the Cardiorespiratory Physiotherapy laboratory and clinics of Pilates in the region, in which the voluntary of the Pilates group would start the Pilates method.
The study included women with body mass index (BMI) ≤ 29 kg/m2 were not engaged in regular physical activity, or sedentary lifestyle with scores up to eight, according to Baecke et al., non-smoker, non-alcoholic, without any abnormalities of the cardiovascular, respiratory and neuromuscular.
The study excluded women with disabling diseases, pregnancy, postpartum less than a year, inability to understand the tests and exercises proposed or refuse to participate in the study.
The volunteers, aged between 25 and 55 years, were allocated in to two groups:
- Pilates Group (n = 16): sedentary volunteers, but that would begin activities with the Pilates method and evaluated three months.
- Control group (n = 13): sedentary volunteers and remain sedentary and evaluated in three months.
- Conditions
- Exercise
- Being tested
- Pilates method
- Keywords
- Exercise, spirometry, muscle strength, physical therapy modalities
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates methodOther
Therapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions. For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | Sedentary volunteers, but that would begin activities with the Pilates method and evaluated in three months.
Therapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions.
For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load. Receives: Other: Pilates method |
| Control Group | No intervention | Sedentary volunteers and remain sedentary and evaluated in three months. The volunteers comprised the control group did not perform any physical activity during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Measured: Three months
Thoracoabdominal mobility
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal, during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Measured: Three months
Respiratory muscle strength
Respiratory muscle strength was assessed by measuring maximal respiratory pressures (MRP) with the use of an analog manometer, with operating range of ± 300 cmH2O.
The maximal inspiratory pressure (MIP) was measured from a maximal expiration, near the residual volume. The maximal expiratory pressure (MEP) was measured from a maximal inspiration, near total lung capacity. Each inspiratory or expiratory effort was sustained for at least two seconds and was respected the 45 seconds between each maneuver.
To minimize the learning effect five measurements were performed and the difference between them should be as high as 10%. Was considered for analysis the highest value obtained.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Maria Pazzianotto Forti, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841385
- Sponsor's protocol ID
- Pilates2012
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Application of the Pilates Method on Pulmonary Function, Thoracic Mobility and Respiratory Muscle Strength
- ClinicalTrials.gov ID
- NCT01841385
- Acronym / sponsor ID
- Pilates2012
- Conditions
- Exercise
- Keywords
- Exercise, spirometry, muscle strength, physical therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Apr 2013 (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 aim of this study was to evaluate the influence of a fitness program from the application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in women.
Detailed description
Study in the Cardiorespiratory Physiotherapy laboratory and clinics of Pilates in the region, in which the voluntary of the Pilates group would start the Pilates method.
The study included women with body mass index (BMI) ≤ 29 kg/m2 were not engaged in regular physical activity, or sedentary lifestyle with scores up to eight, according to Baecke et al., non-smoker, non-alcoholic, without any abnormalities of the cardiovascular, respiratory and neuromuscular.
The study excluded women with disabling diseases, pregnancy, postpartum less than a year, inability to understand the tests and exercises proposed or refuse to participate in the study.
The volunteers, aged between 25 and 55 years, were allocated in to two groups:
- Pilates Group (n = 16): sedentary volunteers, but that would begin activities with the Pilates method and evaluated three months.
- Control group (n = 13): sedentary volunteers and remain sedentary and evaluated in three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates methodSedentary volunteers, but that would begin activities with the Pilates method and evaluated in three months. Therapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions. For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load. |
| Control Group | No intervention | –Sedentary volunteers and remain sedentary and evaluated in three months. The volunteers comprised the control group did not perform any physical activity during the study period. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- body mass index (BMI) ≤ 29 kg/m2
- not physically active on a regular basis, ie, sedentary lifestyle with scores up to eight, according to Baecke et al.
- nonsmokers
- non-alcoholic
- without any abnormalities in the cardiovascular, respiratory or neuromuscular
Key exclusion criteria (4 listed)
- disabling diseases
- gestation
- puerperium there is less than a year
- inability to understand the tests and exercises proposed
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 methodTherapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions. For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load. | Other | Pilates Group |
Primary outcome
Pulmonary function
Time frame: Three months
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Thoracoabdominal mobility
Time frame: Three months
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal, during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Respiratory muscle strength
Time frame: Three months
Respiratory muscle strength was assessed by measuring maximal respiratory pressures (MRP) with the use of an analog manometer, with operating range of ± 300 cmH2O. The maximal inspiratory pressure (MIP) was measured from a maximal expiration, near the residual volume. The maximal expiratory pressure (MEP) was measured from a maximal inspiration, near total lung capacity. Each inspiratory or expiratory effort was sustained for at least two seconds and was respected the 45 seconds between each maneuver. To minimize the learning effect five measurements were performed and the difference between them should be as high as 10%. Was considered for analysis the highest value obtained.
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 29 Apr 2013.
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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 method in people with Exercise, run by Universidade Metodista de Piracicaba 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 5 inclusion and 4 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 29 Apr 2013. 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.
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?
Pulmonary function (time frame: Three months). The study lists 3 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 29 Apr 2013.