Viewing Study NCT04257630



Ignite Creation Date: 2024-05-06 @ 2:14 PM
Last Modification Date: 2024-10-26 @ 1:27 PM
Study NCT ID: NCT04257630
Status: UNKNOWN
Last Update Posted: 2020-02-07
First Post: 2020-01-28

Brief Title: Coping Strategies Within Pulmonary Rehabilitation in Patients With IPF and COPD
Sponsor: Schön Klinik Berchtesgadener Land
Organization: Schön Klinik Berchtesgadener Land

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2020-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 fearanxiety 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 eg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None