Chronic Obstructive Pulmonary DiseaseNCT04363723
The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in COPD Patients Awaiting Lung Transplantation
An observational study of Chronic Obstructive Pulmonary Disease, run by Klaus Kenn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary Rehabilitation
- How many people
- 559 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2020to 10 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: data will be collected from the internal database of the reference Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary Rehabilitation
- Keywords
- COPD, Exacerbation COPD, pulmonary rehabilitation, lung transplantation, acute exacerbation, waiting list, end-stage lung disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: day 1 and last day of pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start23 Apr 2020
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaus Kenn
- Sponsor type
- University, hospital or other
- Collaborators
- Schön Klinik Berchtesgadener Land
- Responsible party
- Sponsor-investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Rembert A Koczulla, MD, Principal investigator, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363723
- Sponsor's protocol ID
- AECOPD pre-LTX
- Status last verified
- Jun 2020
- First submitted
- 23 Apr 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34158456
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease Awaiting Lung Transplantation
- ClinicalTrials.gov ID
- NCT04363723
- Acronym / sponsor ID
- AECOPD pre-LTX
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Exacerbation COPD, pulmonary rehabilitation, lung transplantation, acute exacerbation, waiting list, end-stage lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Klaus KennUniversity, hospital or other
- Collaborators
- Schön Klinik Berchtesgadener Land
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with an acute exacerbation during Rehabilitation | – | Other: Pulmonary RehabilitationPatients 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 | – | Other: Pulmonary RehabilitationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- data will be collected from the internal database of the reference Center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationPatients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration. | Other | patients with an acute exacerbation during Rehabilitation, patients without an acute exacerbation during Rehabilitation |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 34158456Gloeckl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rembert A Koczulla, MD principal investigator
Schoen Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Klaus Kenn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (time frame: day 1 and last day of pulmonary rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.