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Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190461
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Spanish Society of Pneumology and Thoracic Surgery
Spanish Clinical Research Network - SCReN
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Procedure: Early Respiratory Rehabilitation Program Procedure: Conventional Respiratory Rehabilitation Program Not Applicable

Detailed Description:
Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL). Sixty patients will be randomized into the two groups: ERR starts the program during admission and continues at home immediately after discharge for a period of 3 months; CRR was started at home one month after discharge from hospital and continues for 3 months. Recruitment of patients and starting the RR program will occur in the first year. In the second year we will continue the intervention to those who have not completed the year. Follow-up will last until the completion of the year of all patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 9, 2017
Actual Study Completion Date : June 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Respiratory Rehabilitation
Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.
Procedure: Early Respiratory Rehabilitation Program
Active Comparator: Conventional Respiratory Rehabilitation
Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
Procedure: Conventional Respiratory Rehabilitation Program



Primary Outcome Measures :
  1. Exacerbations [ Time Frame: 1 year ]
    Exacerbations with or without admission due to respiratory illness


Secondary Outcome Measures :
  1. Dyspnea [ Time Frame: 1 year ]
    dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire

  2. Functional capacity [ Time Frame: 1 year ]
    Exercise capacity with the six minutes walk test

  3. Quality of life related to health [ Time Frame: 1 year ]
    Quality of life related to health from self-administered CAT and CRC questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> 40 years
  • Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry
  • Having frequent re-admissions (≥ 2 times / year).
  • Sign the informed consent.

Exclusion Criteria:

  • Have completed a pulmonary rehabilitation program (including training) in the last 6 months.
  • Respiratory and / or cardiac serious associated diseases.
  • End-stage COPD (inability to perform exercises or treatment with morphine).
  • Prognosis of <6 months.
  • Living in a residence or not having a primary caregiver.
  • Cognitive disorders that prevent active participation.
  • Patients who are admired to other hospitalization rooms than Pneumology.
  • Patients who do not belong to the area of health coverage of the Respiratory Rehabilitation home team

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190461


Locations
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Spain
Servicio de Neumología Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Society of Pneumology and Thoracic Surgery
Spanish Clinical Research Network - SCReN
Investigators
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Principal Investigator: Fátima E Morante, Nurse Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02190461    
Other Study ID Numbers: IIBSP-EXA-2013-04
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Early Respiratory Rehabilitation
Chronic Obstructive Pulmonary Disease
Re-admitted patients
Open clinical trial
Exacerbations
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive