Clinical trial NCT02190461: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Official title: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Early Respiratory Rehabilitation
Chronic Obstructive Pulmonary Disease
Re-admitted patients
Open clinical trial
Exacerbations
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Spanish Society of Pneumology and Thoracic Surgery
name: Spanish Clinical Research Network - SCReN
First posted: 2014-07-15
Enrollment: 39
Sex: ALL
Minimum age (years): 41
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Dyspnea
timeFrame: 1 year
measure: Functional capacity
timeFrame: 1 year
measure: Quality of life related to health
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servicio de Neumología Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Fátima E Morante, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guell-Rous MR, Morante-Velez F, Flotats-Farre G, Paz-Del Rio LD, Closa-Rusines C, Ouchi-Vernet D, Segura-Medina M, Bolibar-Ribas I. Timing of Pulmonary Rehabilitation in Readmitted Patients with Severe Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. COPD. 2021 Feb;18(1):26-34. doi: 10.1080/15412555.2020.1856059. Epub 2020 Dec 7.