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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: Conventional Respiratory Rehabilitation Program; Procedure: Early Respiratory Rehabilitation Program

• Registration Number: NCT02190461
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Primary Completion: 2017-06-09
• Study Completion: 2017-06-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Respiratory Rehabilitation	Conventional Respiratory Rehabilitation Program	Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
Early Respiratory Rehabilitation	Early Respiratory Rehabilitation Program	Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.

Primary Outcome Measures

Name	Time	Method
Exacerbations	1 year	Exacerbations with or without admission due to respiratory illness

Secondary Outcome Measures

Name	Time	Method
Functional capacity	1 year	Exercise capacity with the six minutes walk test
Dyspnea	1 year	dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
Quality of life related to health	1 year	Quality of life related to health from self-administered CAT and CRC questionnaires

Trial Locations

Locations (1)

Servicio de Neumología Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain