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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Pulmonary Rehabilitation

• Registration Number: NCT04363723
• Lead Sponsor: Klaus Kenn

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-23
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Primary Completion: 2020-05-10
• Study Completion: 2020-05-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with an acute exacerbation during Rehabilitation	Pulmonary Rehabilitation	Patients with severe chronic obstructive pulmonary disease awaiting lung Transplantation that developed an acute exacerbation during a pulmonary Rehabilitation program but continued the Rehabilitation program
patients without an acute exacerbation during Rehabilitation	Pulmonary Rehabilitation	Patients with severe chronic obstructive pulmonary disease awaiting lung Transplantation that did not develop an acute exacerbation during a pulmonary Rehabilitation program and completed the Rehabilitation program regularly.

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk distance	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	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)

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany