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临床试验/NCT03767556
NCT03767556已完成不适用

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

Universidade Metodista de Piracicaba1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
EVALUATION OF LUNG VOLUMES AND CAPACITIES

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Control

No Intervention

This group will not receive intervention

Inspiratory Muscle Training

Experimental

This group, for inspiratory muscle training, will use the Powerbreathe® K5 device. This device will be adjusted with a load of 55% of previously assessed MIP. The volunteer will be instructed to inhale with sufficient force to overcome the resistance of the equipment and subsequently perform a normal expiration. During the 4-week period of respiratory muscle training volunteers will be instructed to perform 2 sets with 30 inspiratory efforts, 5 days a week. The training load will be readjusted on the first day of training each week, after a new reassessment of the PIMax in order to guarantee the overload during inspiratory muscle training.

干预措施: Inspiratory muscle training (Procedure)

结局指标

主要结局

EVALUATION OF LUNG VOLUMES AND CAPACITIES

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Maria Pazzianotto Forti

Principal Investigador

Universidade Metodista de Piracicaba

研究点 (1)

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