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

Study Overview
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: Early Respiratory Rehabilitation Program
* Procedure: Conventional Respiratory Rehabilitation Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Respiratory Rehabilitation<br>Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months. | Procedure: Early Respiratory Rehabilitation Program<br> <br> |
| Active Comparator: Conventional Respiratory Rehabilitation<br>Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months. | Procedure: Conventional Respiratory Rehabilitation Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations | Exacerbations with or without admission due to respiratory illness | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations