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OpenTrials
Completed

NCT Number: NCT04363723

The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in COPD Patients Awaiting Lung Transplantation

Data from chronic obstructive pulmonary disease patients awaiting lung transplantation which performed a pulmonary rehabilitation program will be analyzed retrospectively. Acute exacerbations occur frequently in these patients and have a major impact on the course of the disease. This study investigates the prevalence and the impact of acute exacerbations during pulmonary Rehabilitation in patients with severe chronic obstructive pulmonary disease patients awaiting lung Transplantation that continued the Rehabilitation program despite an acute exacerbation. Data will be taken from the internal database of the reference center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where these data were collected during clinical routine.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of chronic obstructive pulmonary disease including patients with alpha-1 antitrypsin deficiency
  • listed for lung Transplantation or in the Evaluation process for lung transplantation
  • performed a pulmonary rehabilitation program at the reference center

Exclusion criteria

  • patients that discontinued the pulmonary Rehabilitation program due to any reason and could therefore not perform assessement tests at the end of regular Rehabilitation program

Treatment and study plan

Pulmonary Rehabilitation

Other

Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.

Primary outcomes

  1. Change in 6-minute walk distance

    Time frame: day 1 and last day of pulmonary rehabilitation

    The 6-minute walk test will be performed in accordance to the Guidelines of the European Respiratory Society and the American Thoracic Society

  2. Change in Quality of life

    Time frame: day 1 and last day of pulmonary rehabilitation

    health-related Quality of life will be assessed by the physical and mental health component score of the short form 36 health survey (score from 0 to 100 with higher scores indicating better quality of life)

Sponsors and collaborators

Lead sponsor

Klaus Kenn

Other

Collaborators

  • Schön Klinik Berchtesgadener Land

Registry information

Official study title

The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2020
Registry last updated
Jun 29, 2020

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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