Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
1 other identifier
interventional
39
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2017
CompletedSeptember 6, 2018
September 1, 2018
4.2 years
July 11, 2014
September 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exacerbations
Exacerbations with or without admission due to respiratory illness
1 year
Secondary Outcomes (3)
Dyspnea
1 year
Functional capacity
1 year
Quality of life related to health
1 year
Study Arms (2)
Early Respiratory Rehabilitation
EXPERIMENTALStarting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.
Conventional Respiratory Rehabilitation
ACTIVE COMPARATORStarted a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- Age\> 40 years
- Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry
- Having frequent re-admissions (≥ 2 times / year).
- Sign the informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Neumología Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Related Publications (1)
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.
PMID: 33287581DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fátima E Morante, Nurse
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 15, 2014
Study Start
April 1, 2013
Primary Completion
June 9, 2017
Study Completion
June 9, 2017
Last Updated
September 6, 2018
Record last verified: 2018-09