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Completed

NCT Number: NCT02190461

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

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).

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Key information

Age range

41 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Neumología Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Respiratory Rehabilitation Program

Procedure

Conventional Respiratory Rehabilitation Program

Procedure

Primary outcomes

  1. Exacerbations

    Time frame: 1 year

    Exacerbations with or without admission due to respiratory illness

Secondary outcomes

  1. Dyspnea

    Time frame: 1 year

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

  2. Functional capacity

    Time frame: 1 year

    Exercise capacity with the six minutes walk test

  3. Quality of life related to health

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2014
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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