Clinical trial NCT03767556: Effects of Respiratory Muscle Training in Obese Women
Official title: Effects of Respiratory Muscle Training on Lung Function, Respiratory Muscle Function and Physical Fitness in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate or Impaired Respiratory Function
Diabetes
Hypertension
Keywords: physical tests
functional capacity
spirometry
travelled distance
cardiorespiratory fitness
flexibility
respiratory pressures
dyspnea
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: EVALUATION OF LUNG VOLUMES AND CAPACITIES
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
Secondary outcomes:
measure: EVALUATION OF PHYSICAL ACTIVITY LEVEL
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
measure: 6-MINUTE DEGREE TEST (TD6)
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
measure: INCREMENTAL SHUTTLE WALKING TEST (ISWT)
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
measure: TEST TO SIT AND LIFT
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
measure: EVALUATION OF INSPIRATORY MUSCLE STRENGTH
timeFrame: before and after the intervention, for 2 days with a 72-hour interval
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Universidade Metodista de Piracicaba (UNIMEP)
state: São Paulo
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Eli M Pazzianoto-Forti, Phd
role: PRINCIPAL_INVESTIGATOR
References: