Idiopathic Pulmonary Fibrosis and COPDNCT03477526
Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation
A study testing Pulmonary rehabilitation program in people with Idiopathic Pulmonary Fibrosis and COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis and COPD
- What is being tested?
- Pulmonary rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 26 Feb 2019to 27 Feb 2019
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD III-IV
- IPF according Pulmonary Guidelines
Who cannot join
- < 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Status and Develepment Mental Quality of Life in Lung Fibrosis in Comparison of COPD Inpatients Before and After Pulmonary Rehabilitation
As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression
- Conditions
- Idiopathic Pulmonary Fibrosis and COPD
- Being tested
- Pulmonary rehabilitation program
- Keywords
- pulmonary fibrosis, COPD, pulmonary rehabilitation, mental status (anxiety and depression), quality of life, physical activity
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Anxiety Disorders, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation programProcedure or surgery
3 weeks, ...
| Study group | Role | What they receive |
|---|---|---|
| COPD patients (GOLD stage III-IV) | Experimental | Not described Receives: Procedure: Pulmonary rehabilitation program |
| IPF patients | Active comparator | Not described Receives: Procedure: Pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score
Hospital Anxiety and Depression scale
Measured: 3 weeks
Secondary outcomes (1)
Anxiety score
Hospital Anxiety and Depression scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start26 Feb 2019
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Why it stopped: PhD Student stopped working on this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis and COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Lungenfibrose e.V.
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477526
- Sponsor's protocol ID
- Fibrosis 2016
- Status last verified
- Nov 2020
- First submitted
- 19 Mar 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status and Develepment Mental Quality of Life in Lung Fibrosis in Comparison of COPD Inpatients Before and After Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03477526
- Acronym / sponsor ID
- Fibrosis 2016
- Conditions
- Idiopathic Pulmonary Fibrosis and COPD
- Keywords
- pulmonary fibrosis, COPD, pulmonary rehabilitation, mental status (anxiety and depression), quality of life, physical activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PhD Student stopped working on this project
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Lungenfibrose e.V.
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 26 Mar 2018 (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.
As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients (GOLD stage III-IV) | Experimental | Procedure: Pulmonary rehabilitation program |
| IPF patients | Active comparator | Procedure: Pulmonary rehabilitation program |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD GOLD III-IV
- IPF according Pulmonary Guidelines
Key exclusion criteria (1 listed)
- < 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient
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 rehabilitation program3 weeks, ... | Procedure or surgery | COPD patients (GOLD stage III-IV), IPF patients |
Primary outcome
Anxiety score
Time frame: 3 weeks
Hospital Anxiety and Depression scale
1 secondary outcome
Anxiety score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: PhD Student stopped working on this project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation program in people with Idiopathic Pulmonary Fibrosis and COPD, run by Schön Klinik Berchtesgadener Land 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 2 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: stopped early, as of the sponsor's last update on 13 Nov 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 was stopped early (reason given: PhD Student stopped working on this project). Results are not available in the source record.
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?
Anxiety score (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020.