Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Exacerbations
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 41 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Exacerbations
Time Frame: 1 year
Exacerbations with or without admission due to respiratory illness
Secondary Outcomes
- Functional capacity(1 year)
- Dyspnea(1 year)
- Quality of life related to health(1 year)