Effects of Respiratory Muscle Training in Obese Women

NCT ID: NCT03767556

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2019-06-08

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.

Conditions

Inadequate or Impaired Respiratory Function; Diabetes; Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

This group will not receive intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Inspiratory Muscle Training

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.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: PROCEDURE

Powerbreathe® K5

Interventions

Inspiratory muscle training

Powerbreathe® K5

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Eli Maria Pazzianotto Forti

Principal Investigador

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eli M Pazzianoto-Forti, Phd

Role: PRINCIPAL_INVESTIGATOR

Universidade Metodista de Piracicaba

Locations

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Tamires2018

Identifier Type: -

Identifier Source: org_study_id