BronchiectasisNCT02823587
Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis
A study testing Pulmonary Rehabilitation in people with Bronchiectasis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinically stable patients
- both sexes
- aged between 18-60 years
- not due to cystic fibrosis bronchiectasis diagnosis
- non smokers
- no pulmonary disease
Who cannot join
- asthma or other restrictive conditions
- smokers assets
- decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the Protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ribeirão Preto Medical School
Ribeirão Preto, São Paulo, 14049-900
Ada C Gastaldi, Phd, ada@fmrp.usp.br
About this study
Official title: Effects of Pulmonary Rehabilitation on Secretion Transport, Inflammation and Respiratory System Strength and Quality of Life in Patients With Bronchiectasis
The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.
Read the detailed description
Bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. Pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. The aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. In this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. Volunteers will be randomly divided in pulmonary rehabilitation (PRG) and control groups (CG) that will be subdivided in bronchiectasis and healthy subgroups. In the PRG group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while CG will be informed about the benefits of physical activities. All volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. Data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants
- Conditions
- Bronchiectasis
- Being tested
- Pulmonary Rehabilitation, Control
- Keywords
- Bronchiectasis, Mucociliary clearance, Exercise, Inflammation
- Medical subject headings
- Bronchiectasis, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.
ControlOther
No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis Pulmonary Rehabilitation | Experimental | The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks. Receives: Other: Pulmonary Rehabilitation |
| Healthy Pulmonary Rehabilitation | Experimental | In this arm, the volunteers healthy will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks. Receives: Other: Pulmonary Rehabilitation |
| Bronchiectasis Group Control | Sham comparator | The volunteers with bronchiectasis will be informed only about the benefits of physical activities Receives: Other: Control |
| Healthy Group Control | Sham comparator | Volunteers healthy will be informed only about the benefits of physical activities Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucociliary transport in vivo
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)
Measured: Through study completion, an average of 2 years.
Secondary outcomes (15)
Mucociliary transport in vitro
This measurement it will be evaluated by the transport properties in vitro, according to methodology (Trindade, 1997)
Measured: Through study completion, an average of 2 years.
Quality of Life in Bronchiectasis
For this evaluation the investigators will use the Quality of life in bronchiectasis (QOLB) (Chalmers, 2014)
Measured: Through study completion, an average of 2 years.
Cough Impact Assessment
For this evaluation the investigators will use the Leicester Cough Questionnaire (LCQ), (Murray, 2009).
Measured: Through study completion, an average of 2 years.
Health-Related Quality of Life
For this evaluation the investigators will use the Short Form Health Survey (SF-36) (Ware, 1992)
Measured: Through study completion, an average of 2 years.
Impulse Oscillometry System (IOS)
To perform this measure, it is been used Jaeger® IOS(Jaeger, Wurzburg, Germany) with daily volume and resistance calibration. The parameters are calculated at frequencies between 5 and 35 hertz, and will be analyzed the following parameters in this test: resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres).
Measured: Through study completion, an average of 2 years.
Pulmonary Function Test
This test is realized by using KoKo Spirometer™ according American Thoracic Society (ATS)/European Respiratory Society (ATS)recommendations. The analyzed parameters in this test are: forced vital capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC and forced expiratory flow (FEF25-75%).
Measured: Through study completion, an average of 2 years.
Six Minute Walking Test
Patients walk through a 30 meter corridor faster than they can for 6 minutes, according to ATS considerations.
Measured: Through study completion, an average of 2 years.
Maximal Static Respiratory Pressures
It has beem used a digital manometer (MVD300, Global Med, São Paulo, Brazil) with graduation ranging from 0 to ± 300 centimeters of water (cmH2O) and adjusted to a rigid mouthpiece, following the proposed model by Black and Hyatt in 1969.
Measured: Through study completion, an average of 2 years.
Viscosity
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring viscosity of bronchial mucus (Barnett et al, 1970)
Measured: Through study completion, an average of 2 years.
Elasticity
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring elasticity of bronchial mucus (Kim, 1988)
Measured: Through study completion, an average of 2 years.
Exhaled breath condensate
It will be collected as previously described (Koczulla et al., 2009).
Measured: Through study completion, an average of 2 years
Exhaled Nitric Oxide Fraction (FeNO)
It will be performed according to protocol defined by the American Thoracic Society (ATS, 2011), using the device NioxMino™.
Measured: Through study completion, an average of 2 years
Cytokine Analysis TNF-α
The tumor necrosis factor-alpha concentrations (TNF-α) in the nasal lavage fluid(NFL) (samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Measured: Through study completion, an average of 2 years
Cytokine Analysis IL-6
The interleukins(IL) - IL-6 in the NFL samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Measured: Through study completion, an average of 2 years
Cytokine Analysis IL-10
The interleukins - IL-10 in the NFL samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2019 (estimated)
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 BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Clarice Gastaldi, University of Sao Paulo
- Investigators
- Ada C Gastaldi, PhD, Principal investigator, Ribeirão Preto Medicine School - University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823587
- Sponsor's protocol ID
- USP 2016-1
- Status last verified
- Dec 2016
- First submitted
- 19 May 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
PubMed 24328736Stanley P, MacWilliam L, Greenstone M, Mackay I, Cole P. Efficacy of a saccharin test for screening to detect abnormal mucociliary clearance. Br J Dis Chest. 1984 Jan;78(1):62-5.
PubMed 6691910Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.
PubMed 22947443Trindade SH, de Mello JF Jr, Mion Ode G, Lorenzi-Filho G, Macchione M, Guimaraes ET, Saldiva PH. Methods for studying mucociliary transport. Braz J Otorhinolaryngol. 2007 Sep-Oct;73(5):704-12. doi: 10.1016/s1808-8694(15)30133-6.
PubMed 18094814Koczulla R, Dragonieri S, Schot R, Bals R, Gauw SA, Vogelmeier C, Rabe KF, Sterk PJ, Hiemstra PS. Comparison of exhaled breath condensate pH using two commercially available devices in healthy controls, asthma and COPD patients. Respir Res. 2009 Aug 24;10(1):78. doi: 10.1186/1465-9921-10-78.
PubMed 19703285
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Secretion Transport, Inflammation and Respiratory System Strength and Quality of Life in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT02823587
- Acronym / sponsor ID
- USP 2016-1
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Mucociliary clearance, Exercise, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Jul 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.
The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.
Detailed description
Bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. Pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. The aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. In this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. Volunteers will be randomly divided in pulmonary rehabilitation (PRG) and control groups (CG) that will be subdivided in bronchiectasis and healthy subgroups. In the PRG group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while CG will be informed about the benefits of physical activities. All volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. Data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationThe volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks. |
| Healthy Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationIn this arm, the volunteers healthy will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks. |
| Bronchiectasis Group Control | Sham comparator | Other: ControlThe volunteers with bronchiectasis will be informed only about the benefits of physical activities |
| Healthy Group Control | Sham comparator | Other: ControlVolunteers healthy will be informed only about the benefits of physical activities |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- clinically stable patients
- both sexes
- aged between 18-60 years
- not due to cystic fibrosis bronchiectasis diagnosis
- non smokers
Key exclusion criteria (3 listed)
- asthma or other restrictive conditions
- smokers assets
- decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the 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 |
|---|---|---|
| Pulmonary RehabilitationThe exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer. | Other | Bronchiectasis Pulmonary Rehabilitation, Healthy Pulmonary Rehabilitation |
| ControlNo supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits | Other | Bronchiectasis Group Control, Healthy Group Control |
Primary outcome
Mucociliary transport in vivo
Time frame: Through study completion, an average of 2 years.
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)
15 secondary outcomes
Mucociliary transport in vitro
Time frame: Through study completion, an average of 2 years.
Quality of Life in Bronchiectasis
Time frame: Through study completion, an average of 2 years.
Cough Impact Assessment
Time frame: Through study completion, an average of 2 years.
Health-Related Quality of Life
Time frame: Through study completion, an average of 2 years.
Impulse Oscillometry System (IOS)
Time frame: Through study completion, an average of 2 years.
Pulmonary Function Test
Time frame: Through study completion, an average of 2 years.
Six Minute Walking Test
Time frame: Through study completion, an average of 2 years.
Maximal Static Respiratory Pressures
Time frame: Through study completion, an average of 2 years.
Viscosity
Time frame: Through study completion, an average of 2 years.
Elasticity
Time frame: Through study completion, an average of 2 years.
Exhaled breath condensate
Time frame: Through study completion, an average of 2 years
Exhaled Nitric Oxide Fraction (FeNO)
Time frame: Through study completion, an average of 2 years
Cytokine Analysis TNF-α
Time frame: Through study completion, an average of 2 years
Cytokine Analysis IL-6
Time frame: Through study completion, an average of 2 years
Cytokine Analysis IL-10
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Background: PubMed 24328736Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
- Background: PubMed 6691910Stanley P, MacWilliam L, Greenstone M, Mackay I, Cole P. Efficacy of a saccharin test for screening to detect abnormal mucociliary clearance. Br J Dis Chest. 1984 Jan;78(1):62-5.
- Background: PubMed 22947443Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.
- Background: PubMed 18094814Trindade SH, de Mello JF Jr, Mion Ode G, Lorenzi-Filho G, Macchione M, Guimaraes ET, Saldiva PH. Methods for studying mucociliary transport. Braz J Otorhinolaryngol. 2007 Sep-Oct;73(5):704-12. doi: 10.1016/s1808-8694(15)30133-6.
- Background: PubMed 19703285Koczulla R, Dragonieri S, Schot R, Bals R, Gauw SA, Vogelmeier C, Rabe KF, Sterk PJ, Hiemstra PS. Comparison of exhaled breath condensate pH using two commercially available devices in healthy controls, asthma and COPD patients. Respir Res. 2009 Aug 24;10(1):78. doi: 10.1186/1465-9921-10-78.
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Bronchiectasis
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.
Ada C Gastaldi, PhD principal investigator
Ribeirão Preto Medicine School - University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Bronchiectasis, run by University of Sao Paulo 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ada C Gastaldi, PhD (55 16 33150473, ada@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucociliary transport in vivo (time frame: Through study completion, an average of 2 years.). 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 NCT02823587, 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 Aug 2017.