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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02190461
Enrollment
39
Registered
2014-07-15
Start date
2013-04-30
Completion date
2017-06-09
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations

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.

Interventions

PROCEDUREEarly Respiratory Rehabilitation Program
PROCEDUREConventional Respiratory Rehabilitation Program

Sponsors

Spanish Society of Pneumology and Thoracic Surgery
CollaboratorOTHER
Spanish Clinical Research Network - SCReN
CollaboratorNETWORK
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
41 Years to 110 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Exacerbations1 yearExacerbations with or without admission due to respiratory illness

Secondary

MeasureTime frameDescription
Dyspnea1 yeardyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
Functional capacity1 yearExercise capacity with the six minutes walk test
Quality of life related to health1 yearQuality of life related to health from self-administered CAT and CRC questionnaires

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026