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NCT Number: NCT04257630

Coping Strategies Within Pulmonary Rehabilitation in Patients With IPF and 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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Anxiety Disorders Behavior Behavioral Symptoms Chronic Disease Chronic Obstructive Pulmonary Disease Depression Disease Attributes Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schoen Klinik BGL

Schoenau Am Königssee, Bavaria, 83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

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

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

Secondary outcomes

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

    Time frame: Day 1 and Day 21

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

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

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

    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

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

    Time frame: Day 1 and Day 21

    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

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

    Time frame: Day 1 and Day 21

    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.

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

    Time frame: Day 1 and Day 21

    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.

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

    Time frame: Day 1 and Day 21

    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

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

    Time frame: Day 1 and Day 21

    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

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

    Time frame: Day 1 and Day 21

    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

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

    Time frame: Day 1 and Day 21

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

  10. Correlation between physical activity level and Essener Coping questionnaire

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

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

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

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

    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

  12. Correlation between physical activity level and COPD anxiety questionnaire

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

    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.

  13. Correlation between physical activity level and Illness Perception Questionnaire

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

    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.

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

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

    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

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

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

    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

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

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

    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

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

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

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

  18. Differences in Coping mechanisms between IPF and COPD patients

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

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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2020
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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