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Clinical Trials/NCT03767556
NCT03767556
Completed
Not Applicable

Effects of Respiratory Muscle Training on Lung Function, Respiratory Muscle Function and Physical Fitness in Obese Women

Universidade Metodista de Piracicaba1 site in 1 country30 target enrollmentDecember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inadequate or Impaired Respiratory Function
Sponsor
Universidade Metodista de Piracicaba
Enrollment
30
Locations
1
Primary Endpoint
EVALUATION OF LUNG VOLUMES AND CAPACITIES
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The objective of this study will be to evaluate the effects of inspiratory muscle training (IMT) on the physical fitness of obese women

It is believed that the application of these exercises helps in the improvement of inspiratory muscle performance, which should improve physical fitness and thus allow a better performance in the activities of daily living.

Detailed Description

This is a clinical trial, in which adult obese volunteers aged 20-59 years will be evaluated, which will be randomized into two groups: training group (GT) and control group (CG). Both groups should meet the following inclusion criteria: Age between 20 and 59 years, BMI\> 35 and \<55 kg / m², with clinical stability, able to perform the physical tests and acceptance to participate in the study. Women with reports of decompensated heart disease, chronic obstructive pulmonary disease and asthma will be excluded; musculoskeletal and / or neuromuscular changes, which make it impossible to perform the tests. The evaluations will occur in two days with at least 48 hours of interval between them, within a period of seven days, before and after the respiratory muscle training of four weeks. In addition to anamnesis, the initial evaluation will include assessment of pulmonary function (SLF, forced vital capacity (FVC) and maximal voluntary ventilation (VVM)) by spirometry; respiratory muscle evaluation through the measures of Maximum Inspiratory Pressure (PIMax) and maximal sustained inspiratory pressure (PIMaxS); physical fitness assessment through the 6-minute step test (TD6), incremental shuttle walking test (ISWT) and Sentar e Levantar (SL) test, as well as assessment of dyspnea. For the TMI will be used equipment with pressure threshold pressure. During the 4-week period, the IMT will be performed 5 days a week and will consist of 2 series with 30 inspirations. Inspirations will be performed slowly and protracted. The training load will be 55% of the PIMáx readjusted weekly. Statistical analysis will be performed using BioEstat version 5.3. To evaluate the normality of distribution of the data will be used Shapiro-Wilk test. For the comparison of all variables studied, the Student's t-test or the Mann-Wittney test will be used. Pre- and post-training parametric results will also be compared statistically using variance analyzes of two variables (group × time) (ANOVA). Bonferroni tests will be used to examine differences between groups when indicated by ANOVA. The significance level of 5% will be adopted for all analyzes (P \<0.05) where the data will be expressed as mean and standard deviation.

Registry
clinicaltrials.gov
Start Date
December 15, 2018
End Date
June 8, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eli Maria Pazzianotto Forti

Principal Investigador

Universidade Metodista de Piracicaba

Eligibility Criteria

Inclusion Criteria

  • BMI\> 35 and \<55 kg / m²
  • with clinical stability
  • suitable for physical tests
  • acceptance to participate in the study

Exclusion Criteria

  • women with reports of decompensated heart disease
  • chronic obstructive pulmonary disease and asthma
  • musculoskeletal and / or neuromuscular changes,
  • which make it impossible to perform the tests.

Outcomes

Primary Outcomes

EVALUATION OF LUNG VOLUMES AND CAPACITIES

Time Frame: before and after the intervention, for 2 days with a 72-hour interval

Spirometry will be out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). The values extracted will be selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.

Secondary Outcomes

  • EVALUATION OF PHYSICAL ACTIVITY LEVEL(before and after the intervention, for 2 days with a 72-hour interval)
  • INCREMENTAL SHUTTLE WALKING TEST (ISWT)(before and after the intervention, for 2 days with a 72-hour interval)
  • TEST TO SIT AND LIFT(before and after the intervention, for 2 days with a 72-hour interval)
  • EVALUATION OF INSPIRATORY MUSCLE STRENGTH(before and after the intervention, for 2 days with a 72-hour interval)
  • 6-MINUTE DEGREE TEST (TD6)(before and after the intervention, for 2 days with a 72-hour interval)

Study Sites (1)

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