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临床试验/NCT04257630
NCT04257630已完成不适用

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)

Schön Klinik Berchtesgadener Land1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Coping strategies in anxious vs. non-anxious IPF-patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

次要结局

  • Correlation between 6-minute walk distance and Health related Quality of life(Day 1 and Day 21)
  • Correlation between 6-minute walk distance and Essener Coping questionnaire(Day 1 and Day 21)
  • Correlation between Health related Quality of life and Essener Coping questionnaire(Day 1, Day 21 and 3-months after pulmonary rehabilitation program)
  • Correlation between 6-minute walk distance and COPD anxiety questionnaire(Day 1 and Day 21)
  • Correlation between 6-minute walk distance and Hospital Anxiety and Depresion scale(Day 1 and Day 21)
  • Correlation between 6-minute walk distance and Illness Perception Questionnaire(Day 1 and Day 21)
  • Correlation between 6-minute walk distance and Patient-Health questionnaire(Day 1 and Day 21)
  • Correlation between physical activity level and Hospital Anxiety and Depresion scale(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between physical activity level and SF-36 survey(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between physical activity Level and King´s Brief Interstitial lung disease questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between physical activity level and Patient-Health questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between 6-minute walk distance and SF-36 survey(Day 1 and Day 21)
  • Correlation between 6-minute walk distance and King´s Brief Interstitial lung disease questionnaire(Day 1 and Day 21)
  • Correlation between physical activity level and Essener Coping questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between physical activity level and chronic respiratory disease questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Differences in Coping mechanisms between IPF and COPD patients(Day 1, Day 21 and 3-months after pulmonary rehabilitation program (Day 21))
  • Correlation between physical activity level and COPD anxiety questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)
  • Correlation between physical activity level and Illness Perception Questionnaire(2 weeks and 3 months after pulmonary rehabilitation program completion (Day 21) activity monitoring for 5 week days each)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaus Kenn

Professor for pulmonary rehabilitation

Schön Klinik Berchtesgadener Land

研究点 (1)

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