HealthyNCT02094131
Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study
A study testing Voldyne group (VG) and Cliniflo group (CG) in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Voldyne group (VG) and Cliniflo group (CG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Inability to understand and / or perform procedures
- Physically active and very active individuals
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ivanize Mariana Masselli dos Reis
São Carlos, São Paulo, 13565-905
About this 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Voldyne group (VG), Cliniflo group (CG)
- Keywords
- incentive spirometry, flow-oriented spirometer, volume-oriented spirometer, physical therapy, respiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cliniflo group (CG) | Experimental | Training using flow-oriented incentive spirometry Cliniflo Receives: Other: Cliniflo group (CG) |
| Voldyne group (VG) | Experimental | Training using volume-oriented incentive spirometry Voldyne Receives: Other: Voldyne group (VG) |
| Control group (CONG) | No intervention | No intervention. Assessment and reassessment after 5 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 5 weeks
Secondary outcomes (1)
Respiratory muscle strength (Maximal inspiratory and expiratory pressures-manometer)
maximal inspiratory pressure (MIP) (cmH2O) maximal expiratory pressure (MEP) (cmH2O)
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Ivanize Mariana Masselli dos Reis, Universidade Federal de Sao Carlos
- Investigators
- Ivanize Mariana M dos Reis, Specialist, Principal investigator, Universidade Federal de Sao CarlosMauricio Jamami, PhD, Study director, Universidade Federal de Sao CarlosBruna V Pessoa, PhD, Study chair, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094131
- Sponsor's protocol ID
- IMMR-01
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6859656Miller 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.
PubMed 21119213Black 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.
PubMed 5772056Neder 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.
PubMed 10412550Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
PubMed 22008401
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study
- ClinicalTrials.gov ID
- NCT02094131
- Acronym / sponsor ID
- IMMR-01
- Conditions
- Healthy
- Keywords
- incentive spirometry, flow-oriented spirometer, volume-oriented spirometer, physical therapy, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cliniflo group (CG) | Experimental | Other: Cliniflo group (CG)Training using flow-oriented incentive spirometry Cliniflo |
| Voldyne group (VG) | Experimental | Other: Voldyne group (VG)Training using volume-oriented incentive spirometry Voldyne |
| Control group (CONG) | No intervention | –No intervention. Assessment and reassessment after 5 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to understand and / or perform procedures
- Physically active and very active individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Voldyne group (VG) |
| 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. | Other | Cliniflo group (CG) |
Primary outcome
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)
1 secondary outcome
Respiratory muscle strength (Maximal inspiratory and expiratory pressures-manometer)
Time frame: Baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Results publication: PubMed 6859656Knudson 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.
- Results publication: PubMed 21119213Miller 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.
- Results publication: PubMed 5772056Black 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.
- Results publication: PubMed 10412550Neder 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.
- Results publication: PubMed 22008401Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivanize Mariana M dos Reis, Specialist principal investigator
Universidade Federal de Sao Carlos
Mauricio Jamami, PhD study director
Universidade Federal de Sao Carlos
Bruna V Pessoa, PhD study chair
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voldyne group (VG) and Cliniflo group (CG) in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Testing (Spirometry) (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094131, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.