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

NCT02094131 | Completed

• 1 other identifier: IMMR-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

incentive spirometry; flow-oriented spirometer; volume-oriented spirometer; physical therapy; respiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Baseline and 5 weeks

Other Outcomes (1)

• Thoracoabdominal Mobility (Cirtometry Dynamics)

  Baseline and 5 weeks

Study Arms (3)

Cliniflo group (CG)

EXPERIMENTAL

Training using flow-oriented incentive spirometry Cliniflo

Other: Cliniflo group (CG)

Voldyne group (VG)

EXPERIMENTAL

Training using volume-oriented incentive spirometry Voldyne

Other: Voldyne group (VG)

Control group (CONG)

NO INTERVENTION

No intervention. Assessment and reassessment after 5 weeks.

Interventions

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.

Voldyne group (VG)

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.

Cliniflo group (CG)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Ivanize Mariana Masselli dos Reis

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (5)

• 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.

  PMID: 6859656 RESULT

• 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.

  PMID: 21119213 RESULT

• 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.

  PMID: 5772056 RESULT

• 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.

  PMID: 10412550 RESULT

• Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.

  PMID: 22008401 RESULT

Study Officials

• Ivanize Mariana M dos Reis, Specialist

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

• Mauricio Jamami, PhD

  Universidade Federal de Sao Carlos

  STUDY DIRECTOR

• Bruna V Pessoa, PhD

  Universidade Federal de Sao Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 21, 2014
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 21, 2014

Record last verified: 2014-03

Locations

BR (1)