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

September 4, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Servicio de Neumología Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbations
Time Frame: 1 year
Exacerbations with or without admission due to respiratory illness
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 1 year
dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
1 year
Functional capacity
Time Frame: 1 year
Exercise capacity with the six minutes walk test
1 year
Quality of life related to health
Time Frame: 1 year
Quality of life related to health from self-administered CAT and CRC questionnaires
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Spanish Clinical Research Network - SCReN
Spanish Society of Pneumology and Thoracic Surgery

Investigators

  • Principal Investigator: Fátima E Morante, Nurse, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2013

Primary Completion (ACTUAL)

June 9, 2017

Study Completion (ACTUAL)

June 9, 2017

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (ESTIMATE)

July 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-EXA-2013-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Early Respiratory Rehabilitation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe