Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early Respiratory Rehabilitation Program
Conventional Respiratory Rehabilitation Program
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations
Eligibility Criteria
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
Sites / Locations
- Servicio de Neumología Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Respiratory Rehabilitation
Conventional Respiratory Rehabilitation
Arm Description
Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.
Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
Outcomes
Primary Outcome Measures
Exacerbations
Exacerbations with or without admission due to respiratory illness
Secondary Outcome Measures
Dyspnea
dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
Functional capacity
Exercise capacity with the six minutes walk test
Quality of life related to health
Quality of life related to health from self-administered CAT and CRC questionnaires
Full Information
NCT ID
NCT02190461
First Posted
July 11, 2014
Last Updated
September 4, 2018
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Society of Pneumology and Thoracic Surgery, Spanish Clinical Research Network - SCReN
1. Study Identification
Unique Protocol Identification Number
NCT02190461
Brief Title
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Official Title
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 9, 2017 (Actual)
Study Completion Date
June 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Society of Pneumology and Thoracic Surgery, Spanish Clinical Research Network - SCReN
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Respiratory Rehabilitation
Arm Type
Experimental
Arm Description
Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.
Arm Title
Conventional Respiratory Rehabilitation
Arm Type
Active Comparator
Arm Description
Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
Intervention Type
Procedure
Intervention Name(s)
Early Respiratory Rehabilitation Program
Intervention Type
Procedure
Intervention Name(s)
Conventional Respiratory Rehabilitation Program
Primary Outcome Measure Information:
Title
Exacerbations
Description
Exacerbations with or without admission due to respiratory illness
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Dyspnea
Description
dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
Time Frame
1 year
Title
Functional capacity
Description
Exercise capacity with the six minutes walk test
Time Frame
1 year
Title
Quality of life related to health
Description
Quality of life related to health from self-administered CAT and CRC questionnaires
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fátima E Morante, Nurse
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio de Neumología Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33287581
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
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