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Completed

NCT Number: NCT02094131

Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study

Experimental Procedure: The subjects underwent an initial interview in which was filled in a form of anamnesis, in addition to being assessed and reassessed by spirometry, dynamic circumference and manometer. Moreover, responded international physical activity questionnaire (IPAQ - short version) in order to characterize the physical activity level of each participant being classified as inactive, irregularly active, active, and very active. The same examiner performed the assessments and reassessments of individuals after a training program.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivanize Mariana Masselli dos Reis

São Carlos, São Paulo, 13565-905, Brazil

About this study

Spirometry: It was performed by a portable spirometer Easy One® , according to the guidelines of the American Thoracic Society / European Respiratory Society (ATS / ERS). The values obtained were compared with the values predicted by Knudson et al..

Cirtometry Dynamics: provided information on the degree of thoracoabdominal mobility and was performed with the use of a tape measure , which was used to measure the chest circumference during maximal inspiratory and expiratory phase . Measurements were taken horizontally at three different levels: axillary, xiphoid and abdominal, taking as references the axillary fold bottom edge of the xiphoid and umbilicus, respectively. Three measurements on each level were performed.

The maximum values of inspiration and expiration were obtained, being considered for analysis, the highest value of the three measurements and subsequently the Index of Amplitude (IA) proposed by Jamami et al. was calculated in order to mitigate the different dimensions of the chest and abdomen.

Respiratory muscle strength : They were taken with the subject in a sitting position using a digital manometer (MVD300 - Globalmed®) calibrated, nose clip, with the nozzle held firmly between his lips.

The maximal inspiratory pressure (MIP) was obtained by a maximal inspiration preceded by a maximal expiration next to the residual volume (RV) , and to measure maximal expiratory pressure (MEP) a maximal inspiration was next performed to capacity total lung (CPT) followed by a maximal expiration.

The evaluation was considered complete when the individual performed three acceptable measures and, among these, a minimum of two reproducible . The last value found could not be superior to the others. Maneuvers with the support pressure by three seconds, and reproducible measurements with a variation less than or equal to 10% of the highest value were considered acceptable. For analysis was considered the greatest pressure value achieved. MIP and MEP obtained the values predicted by the equations of Neder et al. were compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 30 years
  • Spirometric values within normal limits
  • Body mass index (BMI) between 18 and 29.9 (kg/m2)
  • Without previous or current history of smoking
  • Did not report the presence of neuromuscular, respiratory or cardiac disease

Exclusion criteria

  • Inability to understand and / or perform procedures
  • Physically active and very active individuals

Treatment and study plan

Voldyne group (VG)

Other

VG: slow deep breaths through the mouthpiece of the incentive Voldyne5000® were conducted from the tidal volume (TV) until the total lung capacity (TLC), holding the maximum inspiration. All individuals should maintain "yellow cup" ("yellow flow cup") at a range of flow "Best" in as long as possible. The training lasted approximately 50 minutes, were held twice a week on alternate days, for five consecutive weeks, totaling 10 sessions. Performed three sets of 15 repetitions.

Cliniflo group (CG)

Other

CG: slow deep breaths through the mouthpiece of the incentive Cliniflo® from tidal volume (TV) were performed until the total lung capacity (TLC), holding the maximum inspiration. The volume flow of 100 ml / s for Cliniflo® was standardized, being envisaged to keep the yellow indicator behind the "happy face" for all individuals.The training lasted approximately 50 minutes, were held twice a week on alternate days, for five consecutive weeks, totaling 10 sessions. Performed three sets of 15 repetitions.

Primary outcomes

  1. Pulmonary Function Testing (Spirometry)

    Time frame: up to 5 weeks

    vital capacity (VC) (%predicted) peak expiratory flow (PEF) (%predicted) forced vital capacity (FVC) (%predicted) forced expiratory volume in one second (FEV1) (%predicted) forced expiratory volume in one second/forced vital capacity ratio (FEV1/FVC) maximum voluntary ventilation (MVV) (%predicted)

Secondary outcomes

  1. Respiratory muscle strength (Maximal inspiratory and expiratory pressures-manometer)

    Time frame: Baseline and 5 weeks

    maximal inspiratory pressure (MIP) (cmH2O) maximal expiratory pressure (MEP) (cmH2O)

Other outcomes

  1. Thoracoabdominal Mobility (Cirtometry Dynamics)

    Time frame: Baseline and 5 weeks

    Amplitude Index axillary (AIA) Amplitude Index xiphoid (AIX) Amplitude Index abdominal (AIAB)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 21, 2014
Registry last updated
Mar 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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