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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02190461
Date of registration: 11/07/2014
Prospective Registration: No
Primary sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Public title: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Scientific title: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
Date of first enrolment: April 2013
Target sample size: 39
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02190461
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     Fátima E Morante, Nurse
Address: 
Telephone:
Email:
Affiliation:  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Key inclusion & exclusion 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



Age minimum: 41 Years
Age maximum: 110 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pulmonary Disease, Chronic Obstructive
Intervention(s)
Procedure: Conventional Respiratory Rehabilitation Program
Procedure: Early Respiratory Rehabilitation Program
Primary Outcome(s)
Exacerbations [Time Frame: 1 year]
Secondary Outcome(s)
Quality of life related to health [Time Frame: 1 year]
Dyspnea [Time Frame: 1 year]
Functional capacity [Time Frame: 1 year]
Secondary ID(s)
IIBSP-EXA-2013-04
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Spanish Society of Pneumology and Thoracic Surgery
Spanish Clinical Research Network - CAIBER
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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