Clinical trial NCT03979703: Yoga in Patients With Fibrosing Interstitial Lung Diseases
Official title: Effectiveness of Yoga in Patients With Fibrosing Interstitial Lung Diseases - a Feasibilty and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosing Interstitial Lung Diseases
Idiopathic Pulmonary Fibrosis
Keywords: fibrosing interstitial lung disease
Idiopathic Pulmonary Fibrosis
Yoga
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Lungenfibrose e.V.
First posted: 2019-06-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline quality of life at 12 weeks: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
timeFrame: baseline and 12 week follow-up
measure: Change in physical capacity
timeFrame: baseline and 12 week follow-up
measure: Feasibility of a yoga class in patients with fibrosing interstitial lung diseases: focus group interview
timeFrame: 12 week follow-up
measure: Change from baseline quality of life at 12 weeks: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline and 12 week follow-up
measure: Change from baseline quality of life at 12 weeks: Interstitial Lung Disease Anxiety-questionnaire
timeFrame: baseline and 12 week follow-up
measure: Expectations of study by participants
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg
Study officials:
affiliation: Heidelberg University
name: Michael Kreuter, Prof.
role: PRINCIPAL_INVESTIGATOR
References: