- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232866
Effects of Load Monitoring on Pilates Training
March 2, 2020 updated by: Franciele Marques Vanderle, Paulista University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil, 55
- Franciele Marques Vanderlei
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 34 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male sex
- healthy
- aged between 18 and 36 years
Exclusion Criteria:
- smokers
- alcoholics
- use drugs that influenced cardiac autonomic activity
- cardiovascular, metabolic or endocrine diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
(n = 20) will practice Pilates exercises
|
Pilates methods exercises
|
No Intervention: Control group
(n = 20) will not carry out the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cavina 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.
- de 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
July 25, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 28, 2017
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69459517.8.0000.5402
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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