Coping Strategies Within Pulmonary Rehabilitation in Patients With IPF and COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257630
• Other study ID #: PsyLu-Study
• Status: Recruiting
• Start date: February 6, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2020
• Source: Schön Klinik Berchtesgadener Land
• Contact: Klaus Kenn, Prof.
• Phone: +49 8652 93 2730
• Email: KKenn[@]Schoen-Klinik.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Germany	Schoen Klinik BGL	Schoenau Am Königssee	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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 Mölken 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. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)
Secondary	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	Day 1 and Day 21
Secondary	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	Day 1, Day 21 and 3-months after pulmonary rehabilitation program
Secondary	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	Day 1 and Day 21
Secondary	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.	Day 1 and Day 21
Secondary	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.	Day 1 and Day 21
Secondary	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	Day 1 and Day 21
Secondary	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	Day 1 and Day 21
Secondary	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	Day 1 and Day 21
Secondary	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	Day 1 and Day 21
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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.	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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.	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each
Secondary	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	Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21)