NCT01841385

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

April 23, 2013

Last Update Submit

April 26, 2013

Conditions

Keywords

Exercisespirometrymuscle strengthphysical therapy modalities

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Three months

Study Arms (2)

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.

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.

Interventions

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.

Pilates Group

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • disabling diseases
  • gestation
  • puerperium there is less than a year
  • inability to understand the tests and exercises proposed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 26, 2013

Study Start

October 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 29, 2013

Record last verified: 2013-04

Locations