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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094131
• Other study ID #: IMMR-01
• Status: Completed
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 20, 2014
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2014
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Voldyne group (VG)
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)
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.

Locations

Country	Name	City	State
Brazil	Ivanize Mariana Masselli dos Reis	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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 t — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thoracoabdominal Mobility (Cirtometry Dynamics)	Amplitude Index axillary (AIA) Amplitude Index xiphoid (AIX) Amplitude Index abdominal (AIAB)	Baseline and 5 weeks	Yes
Primary	Pulmonary Function Testing (Spirometry)	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)	up to 5 weeks	Yes
Secondary	Respiratory muscle strength (Maximal inspiratory and expiratory pressures-manometer)	maximal inspiratory pressure (MIP) (cmH2O) maximal expiratory pressure (MEP) (cmH2O)	Baseline and 5 weeks	Yes