NCT03232866

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

July 25, 2017

Last Update Submit

March 2, 2020

Conditions

Keywords

Exercise Movement TechniquesExerciseMonitoring, PhysiologicHeart RateAutonomic Nervous SystemHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)

    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)

    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)

    Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)

Study Arms (2)

Experimental group

EXPERIMENTAL

(n = 20) will practice Pilates exercises

Other: Pilates exercise

Control group

NO INTERVENTION

(n = 20) will not carry out the intervention

Interventions

Pilates methods exercises

Experimental group

Eligibility Criteria

Age18 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male sex
  • healthy
  • aged between 18 and 36 years

You may not qualify if:

  • smokers
  • alcoholics
  • use drugs that influenced cardiac autonomic activity
  • cardiovascular, metabolic or endocrine diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 28, 2017

Study Start

September 1, 2018

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations