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Idiopathic Pulmonary FibrosisNCT04257630

Coping Strategies Within Pulmonary Rehabilitation in Patients With IPF and COPD

An observational study of Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this prospective observational trial is to evaluate the influence of Coping strategies on pulmonary rehabilitation outcomes like 6-minute walk distance and Quality of life. Read more about this study

Who is it for?
Ages 50 to 80 years
How many people
180 participants
Where
1 siteGermany
Study dates
6 Feb 2020to 31 Dec 2024
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who take part in a pulmonary rehabilitation program at Schoen Klinik Berchtesgadener land will recruited.

Who may be able to join

  • Patients with idiopathic pulmonary fibrosis with a FVC between 30 to 70% predicted or
  • Patients with chronic obstructive pulmonary disease (GOLD stage III and IV)
  • Age: 50-80 years
  • Medical treatment according to recent guidelines (including long-term oxygen therapy and or non invasive ventilation)
  • Written informed consent

Who cannot join

  • General exclusion criteria for physical training like acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure or orthopedic co-morbidities which prevent patients from participating in training program
  • Non-compliance

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Schoen Klinik BGL

    Schoenau Am Königssee, Bavaria, 83471

Other trials in Germany

About this study

Official title: Influence of Coping Strategies on Short and Long-term Outcomes of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Chronic Obstructive Pulmonary Disease (COPD)

The aim of this prospective observational trial is to evaluate the influence of Coping strategies on pulmonary rehabilitation outcomes like 6-minute walk distance and Quality of life.

Read the detailed description

In the recent pulmonary rehabilitation (PR) statement of the American Thoracic Society/ European Respiratory Society, PR is mentioned to be beneficial by improving exercise capacity, symptoms and quality of life in patients with other chronic respiratory diseases than chronic obstructive pulmonary disease (COPD) (1). Although patients with idiopathic pulmonary fibrosis (IPF) often suffer from psychological distress such as symptoms of anxiety and depression, only little is known about the impact of these mental co-morbidities on PR outcomes.

In a former study the investigators demonstrated that patients with IPF benefit well from an inpatient PR program of only 3 weeks duration by improving exercise capacity (6-Minute walk distance), health-related quality of life as well as symptoms of anxiety and depression. During the 3-months follow-up after PR, most of these improvements disappeared so that this group showed similar values at follow-up compared to baseline. However, in contrast patients from the control-group with usual care worsened significantly during the 6 months study period.

Interestingly, a linear regression analysis revealed that IPF patients with lower levels of anxiety showed the tendency to have the best sustainability in exercise capacity at the 3 months follow-up. Given that maintenance of exercise capacity may be crucial to influence prognosis and the risk of mortality, reducing symptoms of anxiety might be of special interest.

The negative influence of anxiety symptoms on exercise capacity is a new finding in IPF patients but already known in the field of other chronic diseases: in patients with chronic pain and recently also in patients with COPD, "fear avoidance" behavior is discussed as having a direct negative influence on daily physical activity levels. COPD patients seem to develop fear/anxiety of exercise-related dyspnea due to classical and operant conditioning. This may lead to consecutive avoidance of physical activity and other exercises in daily life (2).

Anxiety symptoms and psychological distress have been shown to be related to patients individual illness perceptions and their way of coping with the disease like e.g. problem-focusing coping, looking for information, depressive coping.

In patients with IPF, the role of coping styles in the context of PR has not been investigated yet. It is unclear whether anxiety symptoms are influenced by individual characteristics of IPF patients such as specific coping strategies and illness perceptions and therefore, whether individual coping strategies might have an influence on the PR outcome.

This latter might be an underestimated issue influencing the PR effects in patients with chronic respiratory diseases. Better knowledge in this field is of special clinical importance in order to ensure short- und long term PR success. Potential differences in psychological profiles or coping strategies between COPD and IPF patients might result in disease-specific interventions during and after PR.

Therforme, aim of this study is to evaluate the influence of coping strategies on pulmonary rehabilitation outcomes.

This study is a prospective observational trial. Asssessments will take place at admission of the rehabilitation program, at discharge and partially after 3-month.

Keywords
coping strategies, psychological burden, anxiety, depression, quality of life, pulmonary rehabilitation
Medical subject headings
Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coping strategies in anxious vs. non-anxious IPF-patients

    Difference in Essener Coping questionnaire in axious (Hospital anxiety and Depression scale [HADS]>=8points) and non-anxious (HADS<8points) IPF-patients

    Measured: Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)

Secondary outcomes (18)

  1. Correlation between 6-minute walk distance and Essener Coping questionnaire

    The essener Coping questionnaire measures coping mechanisms; a 45-item self-report questionnaire; higher scores indicate higher presence of the respective state

    Measured: Day 1 and Day 21

  2. Correlation between Health related Quality of life and Essener Coping questionnaire

    Health related Quality of life will be assessed by chronic respiratory disease questionnaire (CRQ)- a 20-item self-report questionnaire; score 1-7; higher scores indicate a better health-related quality of life

    ; The essener Coping questionnaire measures coping mechanisms; a 45-item self-report questionnaire; higher scores indicate higher presence of the respective state

    Measured: Day 1, Day 21 and 3-months after pulmonary rehabilitation program

  3. Correlation between 6-minute walk distance and Hospital Anxiety and Depresion scale

    Anxiety/Depression measured by Hospital Anxiety and Depression Scale (HADS) - a screening questionnaire including 6 questions about depression and 8 questions about anxiety; higher scores indicate higher presence of anxiety/ depression

    Measured: Day 1 and Day 21

  4. Correlation between 6-minute walk distance and COPD anxiety questionnaire

    assessed by the German "COPD Angst Fragebogen" (CAF) - a 20-item self-report questionnaire, rated on a Lickert-scale (score 0-4); maximum score: 80 points; higher scores indicate higher anxiety levels.

    Measured: Day 1 and Day 21

  5. Correlation between 6-minute walk distance and Illness Perception Questionnaire

    assessed by the Illness perception Questionnaire, revised (IPQ-R) - 18 items, score 1-5; higher scores indicate a worse illness perception, except of item 7,9,10,11,12.

    Measured: Day 1 and Day 21

  6. Correlation between 6-minute walk distance and Patient-Health questionnaire

    Depression measured by Patient-Health questionnaire including 9 items; each question range from 0 to 3; higher scores indicate higher presence of the respective state

    Measured: Day 1 and Day 21

  7. Correlation between 6-minute walk distance and Health related Quality of life

    Health related Quality of life will be assessed by chronic respiratory disease questionnaire (CRQ)- a 20-item self-report questionnaire; score 1-7; higher scores indicate a better health-related quality of life

    Measured: Day 1 and Day 21

  8. Correlation between 6-minute walk distance and SF-36 survey

    Health related quality of life will be measured by SF-36 questionnaire; a screening questionnaire including 36-items; higher score indicate higher quality of life

    Measured: Day 1 and Day 21

  9. Correlation between 6-minute walk distance and King´s Brief Interstitial lung disease questionnaire

    Health Status measured by King's Brief Interstitial lung disease questionnaire including 15 items; higher scores indicate better respective state

    Measured: Day 1 and Day 21

  10. Correlation between physical activity level and Essener Coping questionnaire

    The essener Coping questionnaire measures coping mechanisms; a 45-item self-report questionnaire; higher scores indicate higher presence of the respective state

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  11. Correlation between physical activity level and Hospital Anxiety and Depresion scale

    Anxiety/Depression measured by Hospital Anxiety and Depression Scale (HADS) - a screening questionnaire including 6 questions about depression and 8 questions about anxiety; higher scores indicate higher presence of anxiety/ depression

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  12. Correlation between physical activity level and COPD anxiety questionnaire

    assessed by the German "COPD Angst Fragebogen" (CAF) - a 20-item self-report questionnaire, rated on a Lickert-scale (score 0-4); maximum score: 80 points; higher scores indicate higher anxiety levels.

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  13. Correlation between physical activity level and Illness Perception Questionnaire

    assessed by the Illness perception Questionnaire, revised (IPQ-R) - 18 items, score 1-5; higher scores indicate a worse illness perception, except of item 7,9,10,11,12.

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  14. Correlation between physical activity level and Patient-Health questionnaire

    Depression measured by Patient-Health questionnaire including 9 items; each question range from 0 to 3; higher scores indicate higher presence of the respective state

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  15. Correlation between physical activity level and chronic respiratory disease questionnaire

    Depression measured by Patient-Health questionnaire including 9 Items; each question range from 0 to 3; higher scores indicate higher presence of the respective state

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  16. Correlation between physical activity level and SF-36 survey

    Health related quality of life will be measured by SF-36 questionnaire; a screening questionnaire including 36-items; higher score indicate higher quality of life

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  17. Correlation between physical activity Level and King´s Brief Interstitial lung disease questionnaire

    Health Status measured by King's Brief Interstitial lung disease questionnaire including 15 items; higher scores indicate better respective state

    Measured: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each

  18. Differences in Coping mechanisms between IPF and COPD patients

    The essener Coping questionnaire measures coping mechanisms; a 45-item self-report questionnaire; higher scores indicate higher presence of the respective state

    Measured: Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start6 Feb 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04257630
Sponsor's protocol ID
PsyLu-Study
Status last verified
Apr 2025
First submitted
28 Jan 2020
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PubMed 24127811

  • Hallas CN, Howard C, Theadom A, Wray J. Negative beliefs about breathlessness increases panic for patients with chronic respiratory disease. Psychol Health Med. 2012;17(4):467-77. doi: 10.1080/13548506.2011.626434. Epub 2012 Feb 13.

    PubMed 22329594

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease, 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 5 inclusion and 2 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 30 Apr 2025. 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?

Coping strategies in anxious vs. non-anxious IPF-patients (time frame: Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)). 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 NCT04257630, which also lists 2 linked publications.

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 30 Apr 2025.

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