Pilates MethodNCT03232866
Effects of Load Monitoring on Pilates Training
A study testing Pilates exercise in people with Pilates Method and Exercise, run by Paulista University at 1 site in Brazil.
Trial summary
There has been an increasing awareness about the need to practice some physical activity, including several objectives, mainly as a preventive character. From this perspective, notice the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. Read more about this study
- Who is it for?
- Ages 18 to 36 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pilates Method, Exercise
- What is being tested?
- Pilates exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 18 to 36 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male sex
- healthy
- aged between 18 and 36 years
Who cannot join
- smokers
- alcoholics
- use drugs that influenced cardiac autonomic activity
- cardiovascular, metabolic or endocrine diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Load Monitoring on Pilates Training: a Randomized Clinical Trial
There has been an increasing awareness about the need to practice some physical activity, including several objectives, mainly as a preventive character. From this perspective, notice the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. The objective is monitoring the progression of loads of a 12-week training among the basic, intermediate and advanced levels of the Pilates method through heart rate (HR), subjective exertion perception (PSE) and heart rate variability (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the initial assessment and familiarization with the method, the training period will begin totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During the three months, the participants must pass through the three levels of training: Basic, Intermediate and Advanced. During each session, the investigators will initially collect: psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen saturation). Throughout the session a heart rate meter will be positioned on the chest of the participant to capture HR, which will occur every five minutes together with the PSE illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be analyzed at baseline and after three months of training. In the case of HRV analysis, linear methods in the time and frequency domain will be verified. For the statistical analysis of the cardiorespiratory and autonomic parameters in the pre and post training moments will be used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of the training load will be used the correlation of Pearson or Sperman according to normality. The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC curve.
- Conditions
- Pilates Method, Exercise
- Being tested
- Pilates exercise
- Keywords
- Exercise Movement Techniques, Exercise, Monitoring, Physiologic, Heart Rate, Autonomic Nervous System, Heart rate variability
- 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 exerciseOther
Pilates methods exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | (n = 20) will practice Pilates exercises Receives: Other: Pilates exercise |
| Control group | No intervention | (n = 20) will not carry out the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)
Measured: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
Secondary outcomes (2)
Change from baseline in the subjective perception of effort in different levels of pilates (basic, intermediate and advanced)
Measured: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
Change from baseline in the heart rate in different levels of pilates (basic, intermediate and advanced)
Measured: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Sep 2018
- Primary completion1 May 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pilates MethodStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232866
- Sponsor's protocol ID
- 69459517.8.0000.5402
- Status last verified
- Mar 2020
- First submitted
- 25 Jul 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Souza Cavina AP, Silva NM, Junior EP, Vendrame JW, da Silva GM, da Silva Brandao GH, Pimenta GSOM, da Silva GO, Pastre CM, Vanderlei FM. Vagal modulation after training at different levels of the Pilates method. J Bodyw Mov Ther. 2025 Jun;42:471-476. doi: 10.1016/j.jbmt.2025.01.011. Epub 2025 Jan 13.
PubMed 40325708Cavina AP, Silva NM, Biral TM, Lemos LK, Junior EP, Pastre CM, Vanderlei LC, Vanderlei FM. Effects of 12-week Pilates training program on cardiac autonomic modulation: a randomized controlled clinical trial. J Comp Eff Res. 2021 Dec;10(18):1363-1372. doi: 10.2217/cer-2021-0195. Epub 2021 Oct 21.
PubMed 34672201de Souza Cavina AP, Pizzo Junior E, Machado AF, Biral TM, Pastre CM, Vanderlei FM. Load monitoring on Pilates training: a study protocol for a randomized clinical trial. Trials. 2019 Oct 17;20(1):597. doi: 10.1186/s13063-019-3684-x.
PubMed 31623638
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Load Monitoring on Pilates Training: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03232866
- Acronym / sponsor ID
- 69459517.8.0000.5402
- Conditions
- Pilates Method, Exercise
- Keywords
- Exercise Movement Techniques, Exercise, Monitoring, Physiologic, Heart Rate, Autonomic Nervous System, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Jul 2017 (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.
There has been an increasing awareness about the need to practice some physical activity, including several objectives, mainly as a preventive character. From this perspective, notice the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. The objective is monitoring the progression of loads of a 12-week training among the basic, intermediate and advanced levels of the Pilates method through heart rate (HR), subjective exertion perception (PSE) and heart rate variability (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the initial assessment and familiarization with the method, the training period will begin totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During the three months, the participants must pass through the three levels of training: Basic, Intermediate and Advanced. During each session, the investigators will initially collect: psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen saturation). Throughout the session a heart rate meter will be positioned on the chest of the participant to capture HR, which will occur every five minutes together with the PSE illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be analyzed at baseline and after three months of training. In the case of HRV analysis, linear methods in the time and frequency domain will be verified. For the statistical analysis of the cardiorespiratory and autonomic parameters in the pre and post training moments will be used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of the training load will be used the correlation of Pearson or Sperman according to normality. The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC curve.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Pilates exercise(n = 20) will practice Pilates exercises |
| Control group | No intervention | –(n = 20) will not carry out the intervention |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male sex
- healthy
- aged between 18 and 36 years
Key exclusion criteria (4 listed)
- smokers
- alcoholics
- use drugs that influenced cardiac autonomic activity
- cardiovascular, metabolic or endocrine 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 |
|---|---|---|
| Pilates exercisePilates methods exercises | Other | Experimental group |
Primary outcome
Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)
Time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
2 secondary outcomes
Change from baseline in the subjective perception of effort in different levels of pilates (basic, intermediate and advanced)
Time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
Change from baseline in the heart rate in different levels of pilates (basic, intermediate and advanced)
Time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
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 3 Mar 2020.
- Derived from this study: PubMed 40325708de Souza Cavina AP, Silva NM, Junior EP, Vendrame JW, da Silva GM, da Silva Brandao GH, Pimenta GSOM, da Silva GO, Pastre CM, Vanderlei FM. Vagal modulation after training at different levels of the Pilates method. J Bodyw Mov Ther. 2025 Jun;42:471-476. doi: 10.1016/j.jbmt.2025.01.011. Epub 2025 Jan 13.
- Derived from this study: PubMed 34672201Cavina AP, Silva NM, Biral TM, Lemos LK, Junior EP, Pastre CM, Vanderlei LC, Vanderlei FM. Effects of 12-week Pilates training program on cardiac autonomic modulation: a randomized controlled clinical trial. J Comp Eff Res. 2021 Dec;10(18):1363-1372. doi: 10.2217/cer-2021-0195. Epub 2021 Oct 21.
- Derived from this study: PubMed 31623638de Souza Cavina AP, Pizzo Junior E, Machado AF, Biral TM, Pastre CM, Vanderlei FM. Load monitoring on Pilates training: a study protocol for a randomized clinical trial. Trials. 2019 Oct 17;20(1):597. doi: 10.1186/s13063-019-3684-x.
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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 exercise in people with Pilates Method and Exercise, run by Paulista University 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 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 3 Mar 2020. 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?
Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced) (time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232866, which also lists 3 linked publications.
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 3 Mar 2020.