Pulmonary Disease, Chronic ObstructiveNCT02190461
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
A study testing Early Respiratory Rehabilitation Program and Conventional Respiratory Rehabilitation Program in people with Pulmonary Disease, Chronic Obstructive, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 41 to 110 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Early Respiratory Rehabilitation Program and Conventional Respiratory Rehabilitation Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to 9 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 40 years
- Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry
- Having frequent re-admissions (≥ 2 times / year).
- Sign the informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Neumología Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
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).
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Early Respiratory Rehabilitation Program, Conventional Respiratory Rehabilitation Program
- Keywords
- Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Respiratory Rehabilitation ProgramProcedure or surgery
Conventional Respiratory Rehabilitation ProgramProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early Respiratory Rehabilitation | Experimental | Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months. Receives: Procedure: Early Respiratory Rehabilitation Program |
| Conventional Respiratory Rehabilitation | Active comparator | Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months. Receives: Procedure: Conventional Respiratory Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations
Exacerbations with or without admission due to respiratory illness
Measured: 1 year
Secondary outcomes (3)
Dyspnea
dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
Measured: 1 year
Functional capacity
Exercise capacity with the six minutes walk test
Measured: 1 year
Quality of life related to health
Quality of life related to health from self-administered CAT and CRC questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startApr 2013
- Primary completion9 Jun 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Fátima E Morante, Nurse, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190461
- Sponsor's protocol ID
- IIBSP-EXA-2013-04
- Status last verified
- Sep 2018
- First submitted
- 11 Jul 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33287581
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02190461
- Acronym / sponsor ID
- IIBSP-EXA-2013-04
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Early Respiratory Rehabilitation, Chronic Obstructive Pulmonary Disease, Re-admitted patients, Open clinical trial, Exacerbations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery, Spanish Clinical Research Network - SCReN
- Study start
- Apr 2013 (actual)
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Respiratory Rehabilitation | Experimental | Procedure: Early Respiratory Rehabilitation ProgramStarting 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 comparator | Procedure: Conventional Respiratory Rehabilitation ProgramStarted a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months. |
Who may qualify
- Ages
- 41 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 40 years
- Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry
- Having frequent re-admissions (≥ 2 times / year).
- Sign the informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Respiratory Rehabilitation Program | Procedure or surgery | Early Respiratory Rehabilitation |
| Conventional Respiratory Rehabilitation Program | Procedure or surgery | Conventional Respiratory Rehabilitation |
Primary outcome
Exacerbations
Time frame: 1 year
Exacerbations with or without admission due to respiratory illness
3 secondary outcomes
Dyspnea
Time frame: 1 year
Functional capacity
Time frame: 1 year
Quality of life related to health
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 33287581Guell-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fátima E Morante, Nurse principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Respiratory Rehabilitation Program and Conventional Respiratory Rehabilitation Program in people with Pulmonary Disease, Chronic Obstructive, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.