Clinical trial NCT04257630: Coping Strategies Within Pulmonary Rehabilitation in Patients With IPF and COPD
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Chronic Obstructive Pulmonary Disease
Keywords: coping strategies
psychological burden
anxiety
depression
quality of life
pulmonary rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who take part in a pulmonary rehabilitation program at Schoen Klinik Berchtesgadener land will recruited.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coping strategies in anxious vs. non-anxious IPF-patients
timeFrame: Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)
Secondary outcomes:
measure: Correlation between 6-minute walk distance and Essener Coping questionnaire
timeFrame: Day 1 and Day 21
measure: Correlation between Health related Quality of life and Essener Coping questionnaire
timeFrame: Day 1, Day 21 and 3-months after pulmonary rehabilitation program
measure: Correlation between 6-minute walk distance and Hospital Anxiety and Depresion scale
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and COPD anxiety questionnaire
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and Illness Perception Questionnaire
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and Patient-Health questionnaire
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and Health related Quality of life
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and SF-36 survey
timeFrame: Day 1 and Day 21
measure: Correlation between 6-minute walk distance and King´s Brief Interstitial lung disease questionnaire
timeFrame: Day 1 and Day 21
measure: Correlation between physical activity level and Essener Coping questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and Hospital Anxiety and Depresion scale
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and COPD anxiety questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and Illness Perception Questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and Patient-Health questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and chronic respiratory disease questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity level and SF-36 survey
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Correlation between physical activity Level and King´s Brief Interstitial lung disease questionnaire
timeFrame: 2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
measure: Differences in Coping mechanisms between IPF and COPD patients
timeFrame: Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)
Other outcomes:
Locations:
city: Schoenau am Königssee
country: Germany
facility: Schoen Klinik BGL
state: Bayern
Study officials:
References:
citation: 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.
citation: 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.