search
Back to results

Respiratory Therapy in COPD Exacerbations (TRESEPOCAS)

Primary Purpose

Obstructive Chronic Bronchitis With Acute Exacerbation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
No Respiratory Therapy
Respiratory Therapy
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Chronic Bronchitis With Acute Exacerbation focused on measuring Respiratory muscle training; high-intensity training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Hospitalized patients with acute exacerbation of COPD.

Inclusion Criteria:

  • age over 18 years,
  • hospitalized patients and
  • acute exacerbation of COPD.

Exclusion Criteria:

  • Previous history of any chronic respiratory disease and
  • not to have performed any kind of general or respiratory training in the previous 3 months.

Sites / Locations

  • Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No Respiratory Therapy

Respiratory therapy

Arm Description

Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.

Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measure of safety and tolerability
Presence of complications and patients' satisfaction
Adverse events as a measure of safety and tolerability
Monitoring of health status and possible complications one year after discharge

Full Information

First Posted
April 23, 2014
Last Updated
January 11, 2017
Sponsor
Parc de Salut Mar
search

1. Study Identification

Unique Protocol Identification Number
NCT02125747
Brief Title
Respiratory Therapy in COPD Exacerbations
Acronym
TRESEPOCAS
Official Title
Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Chronic Bronchitis With Acute Exacerbation
Keywords
Respiratory muscle training; high-intensity training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Respiratory Therapy
Arm Type
Other
Arm Description
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.
Arm Title
Respiratory therapy
Arm Type
Experimental
Arm Description
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy
Intervention Type
Other
Intervention Name(s)
No Respiratory Therapy
Intervention Description
Patients received conventional treatment.
Intervention Type
Other
Intervention Name(s)
Respiratory Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary Outcome Measure Information:
Title
Measure of safety and tolerability
Description
Presence of complications and patients' satisfaction
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Title
Adverse events as a measure of safety and tolerability
Description
Monitoring of health status and possible complications one year after discharge
Time Frame
One year after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Hospitalized patients with acute exacerbation of COPD. Inclusion Criteria: age over 18 years, hospitalized patients and acute exacerbation of COPD. Exclusion Criteria: Previous history of any chronic respiratory disease and not to have performed any kind of general or respiratory training in the previous 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Orozco-Levi, MD, PhD
Organizational Affiliation
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
Official's Role
Study Director
Facility Information:
Facility Name
Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
10796474
Citation
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.
Results Reference
background
PubMed Identifier
11359958
Citation
Sivasothy 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.
Results Reference
background
PubMed Identifier
11665507
Citation
Gulsvik A. The global burden and impact of chronic obstructive pulmonary disease worldwide. Monaldi Arch Chest Dis. 2001 Jun;56(3):261-4.
Results Reference
background
PubMed Identifier
16625571
Citation
Elkins 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.
Results Reference
background
PubMed Identifier
7582322
Citation
Standards 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.
Results Reference
background
PubMed Identifier
15943867
Citation
Puhan 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.
Results Reference
background
PubMed Identifier
7938794
Citation
Olseni 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.
Results Reference
background
PubMed Identifier
19819912
Citation
Hill 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.
Results Reference
background
PubMed Identifier
3884288
Citation
Mohsenifar 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.
Results Reference
background
PubMed Identifier
15115864
Citation
Miravitlles 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.
Results Reference
background
PubMed Identifier
79027
Citation
Newton 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.
Results Reference
background
PubMed Identifier
17870457
Citation
Garrod 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.
Results Reference
background
PubMed Identifier
20113757
Citation
Tang 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.
Results Reference
background
PubMed Identifier
2402719
Citation
Lange 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.
Results Reference
background
PubMed Identifier
14606285
Citation
Opdekamp C, Sergysels R. [Respiratory physiotherapy in lung diseases]. Rev Med Brux. 2003 Sep;24(4):A231-5. French.
Results Reference
background
PubMed Identifier
11888949
Citation
Wolkove N, Kamel H, Rotaple M, Baltzan MA Jr. Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD. Chest. 2002 Mar;121(3):702-7. doi: 10.1378/chest.121.3.702.
Results Reference
background
PubMed Identifier
21513439
Citation
Ides K, Vissers D, De Backer L, Leemans G, De Backer W. Airway clearance in COPD: need for a breath of fresh air? A systematic review. COPD. 2011 Jun;8(3):196-205. doi: 10.3109/15412555.2011.560582. Epub 2011 Apr 22. Erratum In: COPD. 2011 Dec;8(6):468. Vissers, Dick [corrected to Vissers, Dirk].
Results Reference
background
PubMed Identifier
17716386
Citation
van der Schans CP. Conventional chest physical therapy for obstructive lung disease. Respir Care. 2007 Sep;52(9):1198-206; discussion 1206-9.
Results Reference
background
PubMed Identifier
22419331
Citation
Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD008328. doi: 10.1002/14651858.CD008328.pub2.
Results Reference
background

Learn more about this trial

Respiratory Therapy in COPD Exacerbations

We'll reach out to this number within 24 hrs