Chronic Obstructive Pulmonary DiseaseNCT02746536
Slow Chest Compression on Dynamic Hyperinflation, Dyspnea and Peripheral Muscle Deoxygenation in Patients With COPD
A study testing Slow chest compression and No slow chest compression in people with Chronic Obstructive Pulmonary Disease, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial summary
Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when performing their activities of daily living (ADLs). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Slow chest compression and No slow chest compression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Mar 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages B, C and D)
- Absence of change in respiratory symptoms in the past four weeks
- No hospital admission in the past 12 weeks
- Age between 40 and 80 years-old
Who cannot join
- Any other disease or health condition that could compromise the test´s execution
- Participation in pulmonary rehabilitation program completed in the last six months
- Current smoking or its cessation in less than six months
- Any change in symptoms during the study protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Núcleo de Assistência, Ensino e Pesquisa em Reabilitação Pulmonar
Florianópolis, Santa Catarina
About this study
Official title: Effects of Slow Chest Compression on Dynamic Hyperinflation, Dyspnea and Peripheral Muscle Deoxygenation Induced by Exercise in Patients With COPD
Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when performing their activities of daily living (ADLs). The slow chest compression (SCC) technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects of SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests. The secondary objective was to identify responders and non-responders to the technique.
Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianopolis, Brazil
Read more
Subjects: Patients with COPD (GOLD 2-4).
Interventions: Patients will randomly receive or not the SCC after six-minute step test (6MST-SCC and 6MST-NonSCC).
Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1 minute after the tests, the dyspnea score will be assessed. The physiological responses and the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after them.
Read the detailed description
The period from August 2015 to April 2016 was designated to clinical trial design and to its submission/approval by the Human Research Ethics Committee. The recruitment of subjects and the study evaluations following described will be only initiated after registration and publication on the ClinicalTrials.gov platform.
Pulmonary function tests:
- Lung function will be tested using a total body plethysmography (Eric Jaeger, Germany), and the calibration will be checked before each evaluation. Spirometry will be performed in accordance with American Thoracic Society and European Respiratory Society (ATS/ERS) standards (Miller et al., 2005; Wanger et al., 2005). The predicted values will be calculated with the equations derived from Brazilian population (Pereira et al., 2007; Neder et al., 1999).
- SVC maneuver: IC will be measured with the patient in the sitting position, using a portable spirometer (NDD Medical Technologies®, Switzerland), before and 1 minute after the tests, by the SVC maneuver starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et al.,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to be considered reliable, two curves could not vary more than 5% or 150 ml. The higher value of two reproducible curves will be used for analysis (O'Donnell et al., 2001). This outcome will be collected by a third evaluator blinded for the SCC or non-SCC application.
Six-minute step test (6MST): The patients will be instructed to walk up and down the step in order to perform the largest number of steps during six minutes. The walking speed will be selected by the patient (da Costa et al., 2014;. Pessoa et al., 2014). Two 6MSTs will be conducted by two evaluators: the main evaluator will be responsible for conducting the tests and the other will count the number of steps performed by the patient.
Dyspnea: Before and after the completion of each 6MST and each 6MWT, patients will be asked about their perception of dyspnea, using the modified Borg scale. Immediately after completion the SCC (or not), patients will be asked again about the dyspnea score. This outcome will be collected by a third evaluator blinded for the SCC or non-SCC application.
Peripheral muscle oxygenation: During the tests, before and after the completion of each 6MST, it will be measured the peripheral muscle oxygenation by near-infrared spectroscopy (NIRS) (Artinis Medical Systems®, Netherlands). The device will be positioned over the vastus lateralis muscle of dominant leg.
Slow chest compression: The patient will receive in a randomized order the application or not of SCC for one minute immediately after 6MST. During the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient. For all patients, during SCC, it will be given a standardized verbal command: "Exhale all the air". After the test in which the patient will not receive the SCC, he/she must remain seated, at rest, for one minute without any interventions, although it will be given the same standardized verbal command.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Slow chest compression, No slow chest compression
- Keywords
- COPD, Inspiratory capacity, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow chest compressionOther
During the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient.
A standardized verbal command will be given: "Exhale all the air".
No slow chest compressionOther
The patient will remain seated at rest for one minute after the 6MST. A standardized verbal command will be given: "Exhale all the air".
| Study group | Role | What they receive |
|---|---|---|
| Slow chest compression | Experimental | Patients will receive the slow chest compression for one minute, immediately after 6MST. Receives: Other: Slow chest compression |
| No slow chest compression | Placebo comparator | Immediately after 6MST, the patient will not receive the SCC and will remain seated at rest for one minute, without any intervention. Receives: Other: No slow chest compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with COPD will perform the inspiratory capacity (IC) by the slow vital capacity (SVC) maneuver in order to measure dynamic hyperinflation (DH).
Dynamic hyperinflation will be considered an increase of 150 ml or 10% on EELV after 6MST and 6MWT. End-expiratory lung volume (EELV) will be measured by the difference between total lung capacity and IC.
Measured: Change from baseline and exactly 1 minute after the 6MST and 6MWT
Patients with COPD will answer dyspnea score by modified Borg scale
Measured: Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.
Patients with COPD will be monitored regarding peripheral muscle oxygenation by the near-infrared spectroscopy
Measured: Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina
- Investigators
- Anamaria F Mayer, PhD, Study director, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746536
- Sponsor's protocol ID
- SCC2016
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2016
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The autors declared that will be shared: individual deidentified participant data; individual data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices); Study Protocol, Statistical Analysis Plan, Informed Consent Form; immediately following publication and ending 5 years following article publication; With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.
Publications
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PubMed 17982531O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
PubMed 11549531Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
PubMed 16135736Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006.
PubMed 10412549da Costa JN, Arcuri JF, Goncalves IL, Davi SF, Pessoa BV, Jamami M, Di Lorenzo VA. Reproducibility of cadence-free 6-minute step test in subjects with COPD. Respir Care. 2014 Apr;59(4):538-42. doi: 10.4187/respcare.02743. Epub 2013 Sep 17.
PubMed 24046461Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.
PubMed 25003275Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.
PubMed 25359356
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slow Chest Compression on Dynamic Hyperinflation, Dyspnea and Peripheral Muscle Deoxygenation Induced by Exercise in Patients With COPD
- ClinicalTrials.gov ID
- NCT02746536
- Acronym / sponsor ID
- SCC2016
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inspiratory capacity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Apr 2016 (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.
Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when performing their activities of daily living (ADLs). The slow chest compression (SCC) technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects of SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests. The secondary objective was to identify responders and non-responders to the technique.
Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianopolis, Brazil
Subjects: Patients with COPD (GOLD 2-4).
Interventions: Patients will randomly receive or not the SCC after six-minute step test (6MST-SCC and 6MST-NonSCC).
Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1 minute after the tests, the dyspnea score will be assessed. The physiological responses and the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after them.
Detailed description
The period from August 2015 to April 2016 was designated to clinical trial design and to its submission/approval by the Human Research Ethics Committee. The recruitment of subjects and the study evaluations following described will be only initiated after registration and publication on the ClinicalTrials.gov platform.
Pulmonary function tests:
- Lung function will be tested using a total body plethysmography (Eric Jaeger, Germany), and the calibration will be checked before each evaluation. Spirometry will be performed in accordance with American Thoracic Society and European Respiratory Society (ATS/ERS) standards (Miller et al., 2005; Wanger et al., 2005). The predicted values will be calculated with the equations derived from Brazilian population (Pereira et al., 2007; Neder et al., 1999).
- SVC maneuver: IC will be measured with the patient in the sitting position, using a portable spirometer (NDD Medical Technologies®, Switzerland), before and 1 minute after the tests, by the SVC maneuver starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et al.,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to be considered reliable, two curves could not vary more than 5% or 150 ml. The higher value of two reproducible curves will be used for analysis (O'Donnell et al., 2001). This outcome will be collected by a third evaluator blinded for the SCC or non-SCC application.
Six-minute step test (6MST): The patients will be instructed to walk up and down the step in order to perform the largest number of steps during six minutes. The walking speed will be selected by the patient (da Costa et al., 2014;. Pessoa et al., 2014). Two 6MSTs will be conducted by two evaluators: the main evaluator will be responsible for conducting the tests and the other will count the number of steps performed by the patient.
Dyspnea: Before and after the completion of each 6MST and each 6MWT, patients will be asked about their perception of dyspnea, using the modified Borg scale. Immediately after completion the SCC (or not), patients will be asked again about the dyspnea score. This outcome will be collected by a third evaluator blinded for the SCC or non-SCC application.
Peripheral muscle oxygenation: During the tests, before and after the completion of each 6MST, it will be measured the peripheral muscle oxygenation by near-infrared spectroscopy (NIRS) (Artinis Medical Systems®, Netherlands). The device will be positioned over the vastus lateralis muscle of dominant leg.
Slow chest compression: The patient will receive in a randomized order the application or not of SCC for one minute immediately after 6MST. During the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient. For all patients, during SCC, it will be given a standardized verbal command: "Exhale all the air". After the test in which the patient will not receive the SCC, he/she must remain seated, at rest, for one minute without any interventions, although it will be given the same standardized verbal command.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow chest compression | Experimental | Other: Slow chest compressionPatients will receive the slow chest compression for one minute, immediately after 6MST. |
| No slow chest compression | Placebo comparator | Other: No slow chest compressionImmediately after 6MST, the patient will not receive the SCC and will remain seated at rest for one minute, without any intervention. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages B, C and D)
- Absence of change in respiratory symptoms in the past four weeks
- No hospital admission in the past 12 weeks
- Age between 40 and 80 years-old
Key exclusion criteria (4 listed)
- Any other disease or health condition that could compromise the test´s execution
- Participation in pulmonary rehabilitation program completed in the last six months
- Current smoking or its cessation in less than six months
- Any change in symptoms during the study protocol
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 |
|---|---|---|
| Slow chest compressionDuring the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient. A standardized verbal command will be given: "Exhale all the air". | Other | Slow chest compression |
| No slow chest compressionThe patient will remain seated at rest for one minute after the 6MST. A standardized verbal command will be given: "Exhale all the air". | Other | No slow chest compression |
Primary outcome
Patients with COPD will perform the inspiratory capacity (IC) by the slow vital capacity (SVC) maneuver in order to measure dynamic hyperinflation (DH).
Time frame: Change from baseline and exactly 1 minute after the 6MST and 6MWT
Dynamic hyperinflation will be considered an increase of 150 ml or 10% on EELV after 6MST and 6MWT. End-expiratory lung volume (EELV) will be measured by the difference between total lung capacity and IC.
Patients with COPD will answer dyspnea score by modified Borg scale
Time frame: Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.
Patients with COPD will be monitored regarding peripheral muscle oxygenation by the near-infrared spectroscopy
Time frame: Change from baseline, after the completion of each 6MST and 6MWT and exactly 1 minute after the SCC or non-SCC.
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 28 Oct 2019.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 17982531Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
- Background: PubMed 11549531O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
- Background: PubMed 16135736Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
- Background: PubMed 10412549Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006.
- Background: PubMed 24046461da Costa JN, Arcuri JF, Goncalves IL, Davi SF, Pessoa BV, Jamami M, Di Lorenzo VA. Reproducibility of cadence-free 6-minute step test in subjects with COPD. Respir Care. 2014 Apr;59(4):538-42. doi: 10.4187/respcare.02743. Epub 2013 Sep 17.
- Background: PubMed 25003275Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.
- Background: PubMed 25359356Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.
- Individual participant dataSharing planned: Yes. The autors declared that will be shared: individual deidentified participant data; individual data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices); Study Protocol, Statistical Analysis Plan, Informed Consent Form; immediately following publication and ending 5 years following article publication; With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.
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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.
Anamaria F Mayer, PhD study director
University of the State of Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow chest compression and No slow chest compression in people with Chronic Obstructive Pulmonary Disease, run by University of the State of Santa Catarina 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 4 inclusion and 4 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 28 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
Patients with COPD will perform the inspiratory capacity (IC) by the slow vital capacity (SVC) maneuver in order to measure dynamic hyperinflation (DH). (time frame: Change from baseline and exactly 1 minute after the 6MST and 6MWT). The study lists 3 primary outcomes in all. 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 NCT02746536, which also lists 8 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 28 Oct 2019.