ConditionsNCT02189044
Pilates and Muscle Strength Respiratory
A study testing Pilates Exercise in people with Conditions, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
Trial summary
Introduction: Among the systems of the organism, it is believed that the respiratory system is the one which gets older faster due to the greater exposure to environmental pollutants over the years.The Pilates method has emerged as a form of fitness particularly providing general welfare to the individual. 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
- Conditions
- What is being tested?
- Pilates Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Dec 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
- age and above 60 years,
- non-practicing regular physical activity
- availability to attend Pilates classes twice a week (in addition to the time UATI)
- with preserved cognitive autonomy
Who cannot join
- history of diseases that directly affect the posture (disc herniation and angular deformities of the spine)
- cardiovascular, respiratory and neurological diseases that prevent attainment of Pilates exercises
- impaired cognitive autonomy or limited capacity for self-determination
- withdrawal of participation during the assessment process
- two consecutive absences or a total of three absences during the proposed training set for the time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Method Pilates Exercises in Muscle Strength Respiratory of Elderly Women: a Clinical Trial
Introduction: Among the systems of the organism, it is believed that the respiratory system is the one which gets older faster due to the greater exposure to environmental pollutants over the years.The Pilates method has emerged as a form of fitness particularly providing general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises on respiratory muscle strength in elderly women. Methods: The investigators have studied 07 women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations, the investigators applied the paired t test and a significance level of 5%.
Read the detailed description
METHODOLOGY This study is a clinical, longitudinal, prospective trial conducted at the Laboratory of Kinesiology and Cinesioterapia of Physiotherapy, Federal University of Triangulo Mineiro - UFTM. All participants signed an informed consent. The research started after approval by the Ethics Committee UFTM Research Protocol (2147-2012).
Subject Initially the invitation was made to all students enrolled in the Open University of Third Age - UATI / UFTM from August to October 2012.
The selection was based on the following inclusion criteria: (1) age and above 60 years, (2) non-practicing regular physical activity, (3) availability to attend Pilates classes twice a week (in addition to the time UATI ) and (4) with preserved cognitive autonomy and exclusion criteria: history (1) diseases that directly affect the posture (disc herniation and angular deformities of the spine), (2) cardiovascular, respiratory and neurological diseases that prevent attainment of Pilates exercises, (3) impaired cognitive capacity limited autonomy or self-determination, (4) withdrawal of participation during the assessment process, and (5) two consecutive absences or a total of three absences during the proposed time for the training set.
Thus, the proposed methodology for this study was applied in seven women with a mean age of 64 ± 6 years.
Review / Procedures The assessment instruments were used: (1) Initial Assessment Sheet, (2) spirometer and (3) manometer.
The record initial assessment and spirometry were applied for the selection of participants. Through the initial evaluation form was possible to assess aspects of health status of participants (associated diseases, blood pressure, respiratory and heart rate, postural assessment) as well as information on personal history, family history and current medication .
A pulmonary function test (spirometry) was performed using the Vitalograph ® spirometer brand model 8600. Equipment was calibrated, and the tests were performed by a single trained and qualified examiner with instructions and standardized voice commands, as I standards advocated by Consensus Brazilian on Espirometria.12 Spirometry was performed to rule out any lung disease that affects the performance of the proposed exercises.
To assess respiratory muscle strength, the volunteers remained in the standing position using a nose clip. Respiratory muscle strength was obtained by the techniques of measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), by means of an analog manometer Generate brand, scaled to ± 300 cmH2O, equipped with nozzle adapter, containing a hole 2 mm in diameter, serving as relief of muscles bocais.4 MIP valve was obtained with the maximal inspiration preceded by maximal expiration to residual volume level and MEP through the maximal expiration preceded by a maximal inspiration, to total lung capacity. Were performed at least three maneuvers maximal inspiratory pressure and maximal expiratory pressure, in order to obtain the greatest value from three acceptable.
The measurement of respiratory muscle strength occurred through an analog manometer (Ger-Air ®, São Paulo, Brazil), with scales - 300 to +300 cmH2O (calibrated), equipped with plastic trachea 16 cm long and 2.4 cm internal diameter, hard plastic mouthpiece and drain hole approximately 2 mm in diameter to dissipate the pressures generated by the muscles of the face and orofaringe.13 the maximal inspiratory pressure (MIP) and expiratory pressures were obtained maximum (MEP), carried a maximum of five times, acceptable and reproducible, and in the standing position, using a nose clip, for a time of sustained three seconds. The value of MIP was obtained from residual volume, and MEP from total lung capacity. Volunteers were due verbal encouragement and if there were more than 10% between a measure and another, a new difference maneuver was performed, considering the highest value since this was not the último.14 Therapeutic Intervention - Pilates Method The training through the Pilates exercises were performed in eleven weeks. The participants were instructed not to miss and attend classes twice a week. Each class consisted of five exercises lasting 40 minutes each lesson.
During the first four weeks (1 st to 4 th week) exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.
In the next four weeks (5th to 8th weeks) began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.
In the last four weeks of training (9th to 11th weeks) proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall.
All exercises were performed during expiration. Statistical Analysis Descriptive data analysis was performed, with a mean and standard deviation. For comparative analysis of the data obtained in the pre-and post-intervention, the paired t test was applied (after confirmed the normal distribution of the sample - Shapiro Wilk test). The level of significance was set at 5%. The statistical program used was 18.0 SSPSS.
- Conditions
- Conditions
- Being tested
- Pilates Exercise
- Keywords
- aged;, breathing exercises;, muscle strength.
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExerciseOther
The training through the Pilates exercises were performed in eleven weeks. Each class consisted of five exercises lasting 40 minutes each lesson.
During the first four weeks exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.
In the next four weeks began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.
In the last four weeks of training proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall.
| Study group | Role | What they receive |
|---|---|---|
| exercises; muscle strength | Other | Evaluate the effects of Pilates exercises on respiratory muscle strength in elderly women before and after eleven weeks of training Receives: Other: Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test (spirometry).
Measured: The results were obtained at the end of the eleven weeks of intervention
Secondary outcomes (1)
Respiratory muscle strength
Measured: The results were obtained at the end of the eleven weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConditionsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lislei Jorge Patrizzi, Universidade Federal do Triangulo Mineiro
- Investigators
- Lislei Patrizzi, Principal investigator, Universidade Federal do Triângulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189044
- Sponsor's protocol ID
- UFTM2014
- Status last verified
- Jul 2014
- First submitted
- 15 Jun 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Method Pilates Exercises in Muscle Strength Respiratory of Elderly Women: a Clinical Trial
- ClinicalTrials.gov ID
- NCT02189044
- Acronym / sponsor ID
- UFTM2014
- Conditions
- Conditions
- Keywords
- aged;, breathing exercises;, muscle strength.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jul 2014 (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.
Introduction: Among the systems of the organism, it is believed that the respiratory system is the one which gets older faster due to the greater exposure to environmental pollutants over the years.The Pilates method has emerged as a form of fitness particularly providing general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises on respiratory muscle strength in elderly women. Methods: The investigators have studied 07 women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations, the investigators applied the paired t test and a significance level of 5%.
Detailed description
METHODOLOGY This study is a clinical, longitudinal, prospective trial conducted at the Laboratory of Kinesiology and Cinesioterapia of Physiotherapy, Federal University of Triangulo Mineiro - UFTM. All participants signed an informed consent. The research started after approval by the Ethics Committee UFTM Research Protocol (2147-2012).
Subject Initially the invitation was made to all students enrolled in the Open University of Third Age - UATI / UFTM from August to October 2012.
The selection was based on the following inclusion criteria: (1) age and above 60 years, (2) non-practicing regular physical activity, (3) availability to attend Pilates classes twice a week (in addition to the time UATI ) and (4) with preserved cognitive autonomy and exclusion criteria: history (1) diseases that directly affect the posture (disc herniation and angular deformities of the spine), (2) cardiovascular, respiratory and neurological diseases that prevent attainment of Pilates exercises, (3) impaired cognitive capacity limited autonomy or self-determination, (4) withdrawal of participation during the assessment process, and (5) two consecutive absences or a total of three absences during the proposed time for the training set.
Thus, the proposed methodology for this study was applied in seven women with a mean age of 64 ± 6 years.
Review / Procedures The assessment instruments were used: (1) Initial Assessment Sheet, (2) spirometer and (3) manometer.
The record initial assessment and spirometry were applied for the selection of participants. Through the initial evaluation form was possible to assess aspects of health status of participants (associated diseases, blood pressure, respiratory and heart rate, postural assessment) as well as information on personal history, family history and current medication .
A pulmonary function test (spirometry) was performed using the Vitalograph ® spirometer brand model 8600. Equipment was calibrated, and the tests were performed by a single trained and qualified examiner with instructions and standardized voice commands, as I standards advocated by Consensus Brazilian on Espirometria.12 Spirometry was performed to rule out any lung disease that affects the performance of the proposed exercises.
To assess respiratory muscle strength, the volunteers remained in the standing position using a nose clip. Respiratory muscle strength was obtained by the techniques of measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), by means of an analog manometer Generate brand, scaled to ± 300 cmH2O, equipped with nozzle adapter, containing a hole 2 mm in diameter, serving as relief of muscles bocais.4 MIP valve was obtained with the maximal inspiration preceded by maximal expiration to residual volume level and MEP through the maximal expiration preceded by a maximal inspiration, to total lung capacity. Were performed at least three maneuvers maximal inspiratory pressure and maximal expiratory pressure, in order to obtain the greatest value from three acceptable.
The measurement of respiratory muscle strength occurred through an analog manometer (Ger-Air ®, São Paulo, Brazil), with scales - 300 to +300 cmH2O (calibrated), equipped with plastic trachea 16 cm long and 2.4 cm internal diameter, hard plastic mouthpiece and drain hole approximately 2 mm in diameter to dissipate the pressures generated by the muscles of the face and orofaringe.13 the maximal inspiratory pressure (MIP) and expiratory pressures were obtained maximum (MEP), carried a maximum of five times, acceptable and reproducible, and in the standing position, using a nose clip, for a time of sustained three seconds. The value of MIP was obtained from residual volume, and MEP from total lung capacity. Volunteers were due verbal encouragement and if there were more than 10% between a measure and another, a new difference maneuver was performed, considering the highest value since this was not the último.14 Therapeutic Intervention - Pilates Method The training through the Pilates exercises were performed in eleven weeks. The participants were instructed not to miss and attend classes twice a week. Each class consisted of five exercises lasting 40 minutes each lesson.
During the first four weeks (1 st to 4 th week) exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.
In the next four weeks (5th to 8th weeks) began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.
In the last four weeks of training (9th to 11th weeks) proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall.
All exercises were performed during expiration. Statistical Analysis Descriptive data analysis was performed, with a mean and standard deviation. For comparative analysis of the data obtained in the pre-and post-intervention, the paired t test was applied (after confirmed the normal distribution of the sample - Shapiro Wilk test). The level of significance was set at 5%. The statistical program used was 18.0 SSPSS.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercises; muscle strength | Other | Other: Pilates ExerciseEvaluate the effects of Pilates exercises on respiratory muscle strength in elderly women before and after eleven weeks of training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age and above 60 years,
- non-practicing regular physical activity
- availability to attend Pilates classes twice a week (in addition to the time UATI)
- with preserved cognitive autonomy
Key exclusion criteria (5 listed)
- history of diseases that directly affect the posture (disc herniation and angular deformities of the spine)
- cardiovascular, respiratory and neurological diseases that prevent attainment of Pilates exercises
- impaired cognitive autonomy or limited capacity for self-determination
- withdrawal of participation during the assessment process
- two consecutive absences or a total of three absences during the proposed training set for the time.
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 ExerciseThe training through the Pilates exercises were performed in eleven weeks. Each class consisted of five exercises lasting 40 minutes each lesson. During the first four weeks exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range. In the next four weeks began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's. In the last four weeks of training proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall. | Other | exercises; muscle strength |
Primary outcome
Pulmonary function test (spirometry).
Time frame: The results were obtained at the end of the eleven weeks of intervention
1 secondary outcome
Respiratory muscle strength
Time frame: The results were obtained at the end of the eleven weeks of intervention
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 14 Jul 2014.
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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.
Lislei Patrizzi principal investigator
Universidade Federal do Triângulo Mineiro
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 Exercise in people with Conditions, run by Universidade Federal do Triangulo Mineiro 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 4 inclusion and 5 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 14 Jul 2014. 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 test (spirometry). (time frame: The results were obtained at the end of the eleven weeks of intervention). 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 14 Jul 2014.