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Yoga in Patients With Fibrosing Interstitial Lung Diseases

Study Purpose

Fibrosing interstitial lung diseases are characterized by loss of lung function, which leads to a decrease in quality of life and physical capacity. Several studies have shown an increase in quality of life and physical capacity after increasing physical activity in patients. There is evicence that yoga has a positive influence in patients with chronic obstructive pulmonary diseases, but so far, studies examining the effect of yoga in patients with fibrosing interstitial lung diseases are missing. Study aims are to determine the feasibilty of this study, and to determine the effects of yoga to patients' quality of life and physical capacity. Twenty patients with a fibrosing interstitial lung disease will be recruited and randomly assigned to the intervention or control group. Several questionnaires regarding quality of life will be conducted. Furthermore, the 6 minutes walking test, a lung function test and a biomarker analysis will be conducted at baseline and follow-up. The intervention group will participate in a 12 week yoga class, whereas the controll group will not participate. Yoga classes will be offered to the control group after the study. In addition, focus group interviews will be conducted at baseline and follow-up with the intervention group.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- ability to understand study and study procedure.

- diagnosis of fibrosing interstitial lung disease.

- Age: > 18 years.

- Ability to consent.

Exclusion Criteria:

- Forced Vital Capacity < 50% - Oxygen therapy.

- diagnosis of pulmonary hypertension.

- participant does not understand the study.

- pulmonary infection within the last 4 weeks.

- acute exacerbation within the last 4 weeks.

- other respiratory decline within the last 4 weeks.

- co-morbidities which make yoga training impossible

Trial Details

Trial ID: 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.	NCT03979703
Phase 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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Heidelberg University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Kreuter, Prof.
Principal Investigator Affiliation	Heidelberg University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibrosing Interstitial Lung Diseases, Idiopathic Pulmonary Fibrosis

Additional Details

Patients with a fibrosing interstitial lung disease will be recruited. In total 20 patients will be recruited, 10 for the intervention group and 10 for the control group. The Intervention group will participate in a 12 week yoga class with classes twice a week for about 1 hour. The control group will not participate in a yoga class. At baseline all patients will conduct a 6 minutes walking test, a lung function test, several surveys to measure health related quaility of life (King's Brief Interstitial Lung Disease Questionnaire (K-BILD), Hospital Anxiety and Depression Scale (HADS), Interstitial Lung Disease Anxiety questionnaire), and some blood will be drawn for biomarker analysis. Furthermore, participants in the Intervention group will participate in two focus group interviews, one at baseline and the second one at 12 week follow-up.

Arms & Interventions

Arms

Experimental: Intervention group

Intervention will be a 12 week yoga class

No Intervention: Control group

Control group will not participate in the 12 week yoga class but will participate in Surveys, 6 minute walking test, lung function test, and biomarker analysis. Furthermore, they will be offered a yoga class after the study.

Interventions

Other: - 12 week yoga class

Intervention is a 12 week yoga class with classes twice a week. Each yoga class will last about 1 hour. Furthermore, focus group interviews will be conducted after the first and last yoga class.

Contact a Trial Team

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.