ClinicalTrials.gg
TerminatedNCT03477526Updated Nov 13, 2020

Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation

An interventional study of Pulmonary rehabilitation program in Idiopathic Pulmonary Fibrosis and COPD, sponsored by Schön Klinik Berchtesgadener Land. Terminated at 1 site in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Schön Klinik Berchtesgadener Land · Not applicable, Interventional, and Health services research

Why this study was terminated
PhD Student stopped working on this project
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 76 studies in Idiopathic Pulmonary Fibrosis with a site in Germany — 10 open to participants now, 17 under way, 4 of them phase 3. Idiopathic Pulmonary Fibrosis · Germany.

Enrollment
67th of 68
1 · median 163
Started
2019
with 1 other
No phase
7 of 76
none open now
Registered
32nd of 76
by date
Lead sponsor
5 of 76
Schön Klinik Berchtesgadener Land

Among the 76 studies in Idiopathic Pulmonary Fibrosis with a site in Germany, this one is the 67th largest by enrollment of the 68 interventional ones that give a count, is one of 2 that started in 2019, is one of 7 with no phase, and was the 32nd registered.

Idiopathic Pulmonary Fibrosis

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

Browse Idiopathic Pulmonary Fibrosis studies →

Open to participants now

10 of the 76 studies in Idiopathic Pulmonary Fibrosis with a site in Germany are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 86 Idiopathic Pulmonary Fibrosis studies recruiting now, 56 (65%) set no upper age limit and 8 (9%) stop at 75 or younger; 3 take children under 18; 15 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Idiopathic Pulmonary Fibrosis and COPD

Keywords

  • pulmonary fibrosis
  • COPD
  • pulmonary rehabilitation
  • mental status (anxiety and depression)
  • quality of life
  • physical activity
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • GOLD III-IV
  • IPF according Pulmonary Guidelines

Exclusion criteria

Exclusion Criteria:

\< 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 of the patient

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    COPD patients (GOLD stage III-IV)

    Procedure: Pulmonary rehabilitation program

  • Active comparator
    IPF patients

    Procedure: Pulmonary rehabilitation program

Interventions

  • ProcedurePulmonary rehabilitation program

    3 weeks, ...

06

What researchers measure

Primary outcomes

  1. Anxiety score

    Hospital Anxiety and Depression scale

    Time frame: 3 weeks

Secondary outcomes

  1. Anxiety score

    Hospital Anxiety and Depression scale

    Time frame: 3 months

07

Study locations

1 site
  • Schön Klinik Berchtesgadener Land
    Schönau a.Königssee, 83471, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2019 to primary completion in Feb 2019, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 26, 2018
StartActual
Feb 26, 2019
Primary completionActual
Feb 27, 2019
CompletionActual
Feb 27, 2019
Last update
Nov 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477526
Lead sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Lungenfibrose e.V.
Responsible party
Klaus Kenn (Principal Investigator, Schön Klinik Berchtesgadener Land) — Principal investigator
First posted
Mar 26, 2018
Start date
Feb 26, 2019
Primary completion
Feb 27, 2019
Completion
Feb 27, 2019
Last update
Nov 13, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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