Fibrosing Interstitial Lung DiseasesNCT03979703
Yoga in Patients With Fibrosing Interstitial Lung Diseases
A study testing 12 week yoga class in people with Fibrosing Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fibrosing Interstitial Lung Diseases, Idiopathic Pulmonary Fibrosis
- What is being tested?
- 12 week yoga class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to understand study and study procedure
- diagnosis of fibrosing interstitial lung disease
- Age: > 18 years
- Ability to consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Yoga in Patients With Fibrosing Interstitial Lung Diseases - a Feasibilty and Pilot Study
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.
Read more
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.
Read the 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.
- Being tested
- 12 week yoga class
- Keywords
- fibrosing interstitial lung disease, Idiopathic Pulmonary Fibrosis, Yoga
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 week yoga classOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention will be a 12 week yoga class Receives: Other: 12 week yoga class |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 week follow-up
Change in physical capacity
Physical capacity will be measured by the 6 miuntes walking test
Measured: baseline and 12 week follow-up
Feasibility of a yoga class in patients with fibrosing interstitial lung diseases: focus group interview
Evaluation of the study by a focus group interview
Measured: 12 week follow-up
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).
Measured: baseline and 12 week follow-up
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.
Measured: baseline and 12 week follow-up
Expectations of study by participants
Evaluation of the study by a focus group interview
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosing Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Lungenfibrose e.V.
- Responsible party
- Principal investigator, Michael Kreuter, Heidelberg University
- Investigators
- Michael Kreuter, Prof., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979703
- Sponsor's protocol ID
- Yoga-Study
- Status last verified
- Dec 2020
- First submitted
- 14 May 2019
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yoga in Patients With Fibrosing Interstitial Lung Diseases - a Feasibilty and Pilot Study
- ClinicalTrials.gov ID
- NCT03979703
- Acronym / sponsor ID
- Yoga-Study
- Keywords
- fibrosing interstitial lung disease, Idiopathic Pulmonary Fibrosis, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Lungenfibrose e.V.
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: 12 week yoga classIntervention will be a 12 week yoga class |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ability to understand study and study procedure
- diagnosis of fibrosing interstitial lung disease
- Age: > 18 years
- Ability to consent
Key exclusion criteria (8 listed)
- Forced Vital Capacity < 50%
- Oxygen therapy
- diagnosis of pulmonary hypertension
- participant does not understand the study
- pulmonary infection within the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 week yoga classIntervention 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. | Other | Intervention group |
Primary outcome
Change from baseline quality of life at 12 weeks: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Time frame: baseline and 12 week follow-up
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
Time frame: baseline and 12 week follow-up
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
Time frame: 12 week follow-up
Evaluation of the study by a focus group interview
Change from baseline quality of life at 12 weeks: Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline and 12 week follow-up
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
Time frame: baseline and 12 week follow-up
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
Time frame: baseline
Evaluation of the study by a focus group interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Fibrosing Interstitial Lung Diseases
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 3
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Interstitial Lung Diseases
RecruitingPhase 3
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
Fibrosing Interstitial Lung Disease
RecruitingObservational study
Contribution of the Indoor Environment Medical Advisor in the Management of Fibrosing Hypersensitivity Pneumonitis
Hypersensitivity Pneumonitis
RecruitingPhase 2
Study of ORJ-001 for the Treatment of IPF
Idiopathic Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kreuter, Prof. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 week yoga class in people with Fibrosing Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline quality of life at 12 weeks: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) (time frame: baseline and 12 week follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.