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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||50 Years - 80 Years|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Schön Klinik Berchtesgadener Land|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Pulmonary Fibrosis, Chronic Obstructive Pulmonary Disease|
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.
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If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.