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Clinical Trials/NCT04363723
NCT04363723CompletedNot Applicable

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

Klaus Kenn1 site in 1 country559 target enrollmentStarted: April 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
559
Locations
1
Primary Endpoint
Change in 6-minute walk distance

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Klaus Kenn
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Klaus Kenn

Professor

Schön Klinik Berchtesgadener Land

Study Sites (1)

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