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

NCT04363723 | Completed

• 1 other identifier: AECOPD pre-LTX
• Study Type: observational
• Target: 559
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Exacerbation COPD; pulmonary rehabilitation; lung transplantation; acute exacerbation; waiting list; end-stage lung disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

patients with an acute exacerbation during 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

Other: Pulmonary Rehabilitation

patients without an acute exacerbation during 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.

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

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

patients with an acute exacerbation during Rehabilitation; patients without an acute exacerbation during Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

data will be collected from the internal database of the reference Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klaus Kenn: lead
• Schön Klinik Berchtesgadener Land: collaborator

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

Related Publications (1)

• Gloeckl R, Jarosch I, Leitl D, Schneeberger T, Nell C, Langer D, Koczulla AR, Kenn K. Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation. J Cardiopulm Rehabil Prev. 2021 Jul 1;41(4):267-270. doi: 10.1097/HCR.0000000000000613.

  PMID: 34158456 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rembert A Koczulla, MD

  Schoen Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: April 23, 2020
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

DE (1)