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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363723
• Other study ID #: AECOPD pre-LTX
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: May 10, 2020

Study information

• Verified date: June 2020
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Pulmonary Rehabilitation
Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (2)

Lead Sponsor	Collaborator
Klaus Kenn	Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute walk distance	The 6-minute walk test will be performed in accordance to the Guidelines of the European Respiratory Society and the American Thoracic Society	day 1 and last day of pulmonary rehabilitation
Primary	Change in Quality of life	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)	day 1 and last day of pulmonary rehabilitation