Yoga in Patients With Fibrosing Interstitial Lung Diseases
Primary Purpose
Fibrosing Interstitial Lung Diseases, Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
12 week yoga class
Sponsored by
About this trial
This is an interventional other trial for Fibrosing Interstitial Lung Diseases focused on measuring fibrosing interstitial lung disease, Idiopathic Pulmonary Fibrosis, Yoga
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
Sites / Locations
- Thoraxklinik-Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Intervention will be a 12 week yoga class
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.
Outcomes
Primary Outcome Measures
Change from baseline quality of life at 12 weeks: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Quality of life will be measured with King's Brief Interstitial Lung Disease Questionnaire (K-BILD). It is a 15-item validated questionnaire assessing health status in patients with an interstitial lung disease. Questions are related to three domains: breathlessness and activities, psychological aspects, and chest symptoms. Each question has 7 possible answers. The questionnaire has a scale from 0 - 100, in which 100 means highest quality of life.
Change in physical capacity
Physical capacity will be measured by the 6 miuntes walking test
Feasibility of a yoga class in patients with fibrosing interstitial lung diseases: focus group interview
Evaluation of the study by a focus group interview
Change from baseline quality of life at 12 weeks: Hospital Anxiety and Depression Scale (HADS)
Quality of life will be measured with the Hospital Anxiety and Depression Scale (HADS). It is a 14-item questionnaire, 7 items are related to depression and 7 items are related to anxiety. Each question has 4 different answer options, each scored from 0-3. Scores are summed up for each field (depression or anxiety) with 0 points as lowest possibility and 21 scores as highest (0-7 = normal, 8-10 = borderline abnormal, and 11-21 = abnormal).
Change from baseline quality of life at 12 weeks: Interstitial Lung Disease Anxiety-questionnaire
Quality of life will be measured with Interstitial Lung Disease Anxiety-questionnaire. This is a 37-item questionnaire with 5 answer possibilities for each question (never, rare, sometimes, often, always). Total scores are a sum of all questions. Lowest score = 0, highest score = 136. The higher the score the better is the patients' quality of life.
Expectations of study by participants
Evaluation of the study by a focus group interview
Secondary Outcome Measures
Full Information
NCT ID
NCT03979703
First Posted
May 14, 2019
Last Updated
December 4, 2020
Sponsor
Heidelberg University
Collaborators
Lungenfibrose e.V.
1. Study Identification
Unique Protocol Identification Number
NCT03979703
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Lungenfibrose e.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosing Interstitial Lung Diseases, Idiopathic Pulmonary Fibrosis
Keywords
fibrosing interstitial lung disease, Idiopathic Pulmonary Fibrosis, Yoga
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention will be a 12 week yoga class
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
12 week yoga class
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline quality of life at 12 weeks: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Description
Quality of life will be measured with King's Brief Interstitial Lung Disease Questionnaire (K-BILD). It is a 15-item validated questionnaire assessing health status in patients with an interstitial lung disease. Questions are related to three domains: breathlessness and activities, psychological aspects, and chest symptoms. Each question has 7 possible answers. The questionnaire has a scale from 0 - 100, in which 100 means highest quality of life.
Time Frame
baseline and 12 week follow-up
Title
Change in physical capacity
Description
Physical capacity will be measured by the 6 miuntes walking test
Time Frame
baseline and 12 week follow-up
Title
Feasibility of a yoga class in patients with fibrosing interstitial lung diseases: focus group interview
Description
Evaluation of the study by a focus group interview
Time Frame
12 week follow-up
Title
Change from baseline quality of life at 12 weeks: Hospital Anxiety and Depression Scale (HADS)
Description
Quality of life will be measured with the Hospital Anxiety and Depression Scale (HADS). It is a 14-item questionnaire, 7 items are related to depression and 7 items are related to anxiety. Each question has 4 different answer options, each scored from 0-3. Scores are summed up for each field (depression or anxiety) with 0 points as lowest possibility and 21 scores as highest (0-7 = normal, 8-10 = borderline abnormal, and 11-21 = abnormal).
Time Frame
baseline and 12 week follow-up
Title
Change from baseline quality of life at 12 weeks: Interstitial Lung Disease Anxiety-questionnaire
Description
Quality of life will be measured with Interstitial Lung Disease Anxiety-questionnaire. This is a 37-item questionnaire with 5 answer possibilities for each question (never, rare, sometimes, often, always). Total scores are a sum of all questions. Lowest score = 0, highest score = 136. The higher the score the better is the patients' quality of life.
Time Frame
baseline and 12 week follow-up
Title
Expectations of study by participants
Description
Evaluation of the study by a focus group interview
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kreuter, Prof.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik-Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Yoga in Patients With Fibrosing Interstitial Lung Diseases
We'll reach out to this number within 24 hrs