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

U

Universidade Federal de Sao Carlos

Status

Completed

Conditions

Healthy

Treatments

Other: Voldyne group (VG)
Other: Cliniflo group (CG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02094131
IMMR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

39 participants in 3 patient groups

Cliniflo group (CG)
Experimental group
Description:
Training using flow-oriented incentive spirometry Cliniflo
Treatment:
Other: Cliniflo group (CG)
Voldyne group (VG)
Experimental group
Description:
Training using volume-oriented incentive spirometry Voldyne
Treatment:
Other: Voldyne group (VG)
Control group (CONG)
No Intervention group
Description:
No intervention. Assessment and reassessment after 5 weeks.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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