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

NCT ID: NCT02190461

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-06-09

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early Respiratory Rehabilitation Program

Intervention Type PROCEDURE

Conventional Respiratory Rehabilitation

Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.

Group Type ACTIVE_COMPARATOR

Conventional Respiratory Rehabilitation Program

Intervention Type PROCEDURE

Interventions

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Early Respiratory Rehabilitation Program

Intervention Type PROCEDURE

Conventional Respiratory Rehabilitation Program

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

41 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Pneumology and Thoracic Surgery

OTHER

Sponsor Role collaborator

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fátima E Morante, Nurse

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Servicio de Neumología Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33287581 (View on PubMed)

Other Identifiers

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IIBSP-EXA-2013-04

Identifier Type: -

Identifier Source: org_study_id

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