Clinical trial NCT02094131: Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study
Official title: Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: incentive spirometry
flow-oriented spirometer
volume-oriented spirometer
physical therapy
respiratory muscle training
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-03-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary Function Testing (Spirometry)
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Respiratory muscle strength (Maximal inspiratory and expiratory pressures-manometer)
timeFrame: Baseline and 5 weeks
Other outcomes:
measure: Thoracoabdominal Mobility (Cirtometry Dynamics)
timeFrame: Baseline and 5 weeks
Locations:
city: São Carlos
country: Brazil
facility: Ivanize Mariana Masselli dos Reis
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Ivanize Mariana M dos Reis, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Sao Carlos
name: Mauricio Jamami, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Sao Carlos
name: Bruna V Pessoa, PhD
role: STUDY_CHAIR
References:
citation: Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis. 1983 Jun;127(6):725-34. doi: 10.1164/arrd.1983.127.6.725.
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen R, Macintyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of lung function testing: the authors' replies to readers' comments. Eur Respir J. 2010 Dec;36(6):1496-8. doi: 10.1183/09031936.00130010. No abstract available.
citation: Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
citation: Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
citation: Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.