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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190461
• Other study ID #: IIBSP-EXA-2013-04
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: June 9, 2017

Study information

• Verified date: September 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 9, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Early Respiratory Rehabilitation Program

• Conventional Respiratory Rehabilitation Program

Locations

Country	Name	City	State
Spain	Servicio de Neumología Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Spanish Clinical Research Network - CAIBER, Spanish Society of Pneumology and Thoracic Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbations	Exacerbations with or without admission due to respiratory illness	1 year
Secondary	Dyspnea	dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire	1 year
Secondary	Functional capacity	Exercise capacity with the six minutes walk test	1 year
Secondary	Quality of life related to health	Quality of life related to health from self-administered CAT and CRC questionnaires	1 year