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CompletedNCT02190461Updated Sep 6, 2018

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

An interventional study of Early Respiratory Rehabilitation Program and Conventional Respiratory Rehabilitation Program in Pulmonary Disease, Chronic Obstructive, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 41 Years to 110 Years. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2013, registered Jul 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
41 Years to 110 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Early Respiratory Rehabilitation
  • Chronic Obstructive Pulmonary Disease
  • Re-admitted patients
  • Open clinical trial
  • Exacerbations
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 39 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
41 Years to 110 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Early Respiratory Rehabilitation

    Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.

    Procedure: Early Respiratory Rehabilitation Program

  • Active comparator
    Conventional Respiratory Rehabilitation

    Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.

    Procedure: Conventional Respiratory Rehabilitation Program

Interventions

  • ProcedureEarly Respiratory Rehabilitation Program
  • ProcedureConventional Respiratory Rehabilitation Program
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What researchers measure

Primary outcomes

  1. Exacerbations

    Exacerbations with or without admission due to respiratory illness

    Time frame: 1 year

Secondary outcomes

  1. Dyspnea

    dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire

    Time frame: 1 year

  2. Functional capacity

    Exercise capacity with the six minutes walk test

    Time frame: 1 year

  3. Quality of life related to health

    Quality of life related to health from self-administered CAT and CRC questionnaires

    Time frame: 1 year

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Study locations

1 site
  • Servicio de Neumología Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02190461
Lead 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
Responsible party
Sponsor
First posted
Jul 15, 2014
Start date
Apr 2013
Primary completion
Jun 9, 2017
Completion
Jun 9, 2017
Last update
Sep 6, 2018

Study contacts

Fátima E Morante, Nurse
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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