Obstructive Chronic Bronchitis With Acute ExacerbationTRESEPOCASNCT02125747
Respiratory Therapy in COPD Exacerbations
A study testing No Respiratory Therapy and Respiratory Therapy in people with Obstructive Chronic Bronchitis With Acute Exacerbation, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Chronic Bronchitis With Acute Exacerbation
- What is being tested?
- No Respiratory Therapy and Respiratory Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Nov 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years,
- hospitalized patients and
- acute exacerbation of COPD.
Who cannot join
- Previous history of any chronic respiratory disease and
- not to have performed any kind of general or respiratory training in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar
Barcelona, Barcelona, 08003
About this study
Official title: Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.
Read the detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication.
Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity.
Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.
- Being tested
- No Respiratory Therapy, Respiratory Therapy
- Keywords
- Respiratory muscle training; high-intensity training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Respiratory TherapyOther
Patients received conventional treatment.
Respiratory TherapyOther
Respiratory Therapy consists of postural drainage, positive expiratory pressure (PEP) and vibropercussion (it is a postural drainage method, which uses chest clapping with a flexible wrist and cupped hands or a mechanical vibrator to loosen and mobilize retained secretions that can then be expectorated or drained). Postural drainage is an airways clearance technique in which patient's body is positioned so that the trachea is inclined downward and below the affected chest area.
The PEP consists of expiratory cycles through a system generating a positive pressure of 10-20 cc (cubic centimeter) water. Vibropercussion is applied by the use of a mechanical system following rib movement during expiration to enhance clearance of secretions.
Intervention group received 30-minute-sessions twice a day, 7 days per week, during hospitalization period.
| Study group | Role | What they receive |
|---|---|---|
| No Respiratory Therapy | Other | Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment. Receives: Other: No Respiratory Therapy |
| Respiratory therapy | Experimental | Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy Receives: Other: Respiratory Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Respiratory muscle strength is assessed through maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, patients performed a maximum expiratory effort from total lung capacity in the face of the occluded airway.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes (2)
Measure of safety and tolerability
Presence of complications and patients' satisfaction
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Adverse events as a measure of safety and tolerability
Monitoring of health status and possible complications one year after discharge
Measured: One year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obstructive Chronic Bronchitis With Acute ExacerbationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Marco Navarro, Parc de Salut Mar
- Investigators
- Mauricio Orozco-Levi, MD, PhD, Study director, Biomedical Research Network for Respiratory Diseases (CIBERES), ISCIII, Ministerio de Ciencia y Tecnología, Spain; Respiratory Department, Hospital del Mar, Spain; Respiratory Department, Centro de Investigaciones, Fundación Cardiovascular de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125747
- Sponsor's protocol ID
- PSM/RHB/CR/05
- Acronym
- TRESEPOCAS
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2014
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev. 2000;(2):CD000045. doi: 10.1002/14651858.CD000045.
PubMed 10796474Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.
PubMed 11359958Gulsvik A. The global burden and impact of chronic obstructive pulmonary disease worldwide. Monaldi Arch Chest Dis. 2001 Jun;56(3):261-4.
PubMed 11665507Elkins MR, Jones A, van der Schans C. Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003147. doi: 10.1002/14651858.CD003147.pub3.
PubMed 16625571Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available.
PubMed 7582322Puhan MA, Scharplatz M, Troosters T, Steurer J. Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality -- a systematic review. Respir Res. 2005 Jun 8;6(1):54. doi: 10.1186/1465-9921-6-54.
PubMed 15943867Olseni L, Midgren B, Hornblad Y, Wollmer P. Chest physiotherapy in chronic obstructive pulmonary disease: forced expiratory technique combined with either postural drainage or positive expiratory pressure breathing. Respir Med. 1994 Jul;88(6):435-40. doi: 10.1016/s0954-6111(05)80046-0.
PubMed 7938794Hill K, Patman S, Brooks D. Effect of airway clearance techniques in patients experiencing an acute exacerbation of chronic obstructive pulmonary disease: a systematic review. Chron Respir Dis. 2010;7(1):9-17. doi: 10.1177/1479972309348659. Epub 2009 Oct 9.
PubMed 19819912Mohsenifar Z, Rosenberg N, Goldberg HS, Koerner SK. Mechanical vibration and conventional chest physiotherapy in outpatients with stable chronic obstructive lung disease. Chest. 1985 Apr;87(4):483-5. doi: 10.1378/chest.87.4.483.
PubMed 3884288Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala JL, Masa F, Verea H, Murio C, Ros F, Vidal R; IMPAC Study Group. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax. 2004 May;59(5):387-95. doi: 10.1136/thx.2003.008730.
PubMed 15115864Newton DA, Stephenson A. Effect of physiotherapy on pulmonary function. A laboratory study. Lancet. 1978 Jul 29;2(8083):228-9. doi: 10.1016/s0140-6736(78)91742-7.
PubMed 79027Garrod R, Lasserson T. Role of physiotherapy in the management of chronic lung diseases: an overview of systematic reviews. Respir Med. 2007 Dec;101(12):2429-36. doi: 10.1016/j.rmed.2007.06.007. Epub 2007 Sep 17.
PubMed 17870457Tang CY, Taylor NF, Blackstock FC. Chest physiotherapy for patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease (COPD): a systematic review. Physiotherapy. 2010 Mar;96(1):1-13. doi: 10.1016/j.physio.2009.06.008. Epub 2009 Sep 22.
PubMed 20113757Lange P, Nyboe J, Appleyard M, Jensen G, Schnohr P. Relation of ventilatory impairment and of chronic mucus hypersecretion to mortality from obstructive lung disease and from all causes. Thorax. 1990 Aug;45(8):579-85. doi: 10.1136/thx.45.8.579.
PubMed 2402719Opdekamp C, Sergysels R. [Respiratory physiotherapy in lung diseases]. Rev Med Brux. 2003 Sep;24(4):A231-5. French.
PubMed 14606285
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02125747
- Acronym / sponsor ID
- TRESEPOCAS / PSM/RHB/CR/05
- Keywords
- Respiratory muscle training; high-intensity training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Apr 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.
The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.
Detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication.
Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity.
Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Respiratory Therapy | Other | Other: No Respiratory TherapyPatients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment. |
| Respiratory therapy | Experimental | Other: Respiratory TherapyPatients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18 years,
- hospitalized patients and
- acute exacerbation of COPD.
Key exclusion criteria (2 listed)
- Previous history of any chronic respiratory disease and
- not to have performed any kind of general or respiratory training in the previous 3 months.
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 |
|---|---|---|
| No Respiratory TherapyPatients received conventional treatment. | Other | No Respiratory Therapy |
| Respiratory TherapyRespiratory Therapy consists of postural drainage, positive expiratory pressure (PEP) and vibropercussion (it is a postural drainage method, which uses chest clapping with a flexible wrist and cupped hands or a mechanical vibrator to loosen and mobilize retained secretions that can then be expectorated or drained). Postural drainage is an airways clearance technique in which patient's body is positioned so that the trachea is inclined downward and below the affected chest area. The PEP consists of expiratory cycles through a system generating a positive pressure of 10-20 cc (cubic centimeter) water. Vibropercussion is applied by the use of a mechanical system following rib movement during expiration to enhance clearance of secretions. Intervention group received 30-minute-sessions twice a day, 7 days per week, during hospitalization period. | Other | Respiratory therapy |
Primary outcome
Respiratory muscle strength
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Respiratory muscle strength is assessed through maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, patients performed a maximum expiratory effort from total lung capacity in the face of the occluded airway.
2 secondary outcomes
Measure of safety and tolerability
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Adverse events as a measure of safety and tolerability
Time frame: One year after hospital discharge
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 12 Jan 2017.
- Background: PubMed 10796474Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev. 2000;(2):CD000045. doi: 10.1002/14651858.CD000045.
- Background: PubMed 11359958Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.
- Background: PubMed 11665507Gulsvik A. The global burden and impact of chronic obstructive pulmonary disease worldwide. Monaldi Arch Chest Dis. 2001 Jun;56(3):261-4.
- Background: PubMed 16625571Elkins MR, Jones A, van der Schans C. Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003147. doi: 10.1002/14651858.CD003147.pub3.
- Background: PubMed 7582322Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available.
- Background: PubMed 15943867Puhan MA, Scharplatz M, Troosters T, Steurer J. Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality -- a systematic review. Respir Res. 2005 Jun 8;6(1):54. doi: 10.1186/1465-9921-6-54.
- Background: PubMed 7938794Olseni L, Midgren B, Hornblad Y, Wollmer P. Chest physiotherapy in chronic obstructive pulmonary disease: forced expiratory technique combined with either postural drainage or positive expiratory pressure breathing. Respir Med. 1994 Jul;88(6):435-40. doi: 10.1016/s0954-6111(05)80046-0.
- Background: PubMed 19819912Hill K, Patman S, Brooks D. Effect of airway clearance techniques in patients experiencing an acute exacerbation of chronic obstructive pulmonary disease: a systematic review. Chron Respir Dis. 2010;7(1):9-17. doi: 10.1177/1479972309348659. Epub 2009 Oct 9.
- Background: PubMed 3884288Mohsenifar Z, Rosenberg N, Goldberg HS, Koerner SK. Mechanical vibration and conventional chest physiotherapy in outpatients with stable chronic obstructive lung disease. Chest. 1985 Apr;87(4):483-5. doi: 10.1378/chest.87.4.483.
- Background: PubMed 15115864Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala JL, Masa F, Verea H, Murio C, Ros F, Vidal R; IMPAC Study Group. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax. 2004 May;59(5):387-95. doi: 10.1136/thx.2003.008730.
- Background: PubMed 79027Newton DA, Stephenson A. Effect of physiotherapy on pulmonary function. A laboratory study. Lancet. 1978 Jul 29;2(8083):228-9. doi: 10.1016/s0140-6736(78)91742-7.
- Background: PubMed 17870457Garrod R, Lasserson T. Role of physiotherapy in the management of chronic lung diseases: an overview of systematic reviews. Respir Med. 2007 Dec;101(12):2429-36. doi: 10.1016/j.rmed.2007.06.007. Epub 2007 Sep 17.
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The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
COPD, COPD Exacerbation Acute
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.
Mauricio Orozco-Levi, MD, PhD study director
Biomedical Research Network for Respiratory Diseases (CIBERES), ISCIII, Ministerio de Ciencia y Tecnología, Spain; Respiratory Department, Hospital del Mar, Spain; Respiratory Department, Centro de Investigaciones, Fundación Cardiovascular de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Respiratory Therapy and Respiratory Therapy in people with Obstructive Chronic Bronchitis With Acute Exacerbation, run by Parc de Salut Mar at 1 site in Spain.
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 3 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 12 Jan 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 Spain. 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?
Respiratory muscle strength (time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days). 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 NCT02125747, which also lists 19 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 12 Jan 2017.