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出境医 / 临床实验 / Yoga in Patients With Fibrosing Interstitial Lung Diseases

Yoga in Patients With Fibrosing Interstitial Lung Diseases

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.


Condition or disease Intervention/treatment Phase
Fibrosing Interstitial Lung Diseases Idiopathic Pulmonary Fibrosis Other: 12 week yoga class Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of Yoga in Patients With Fibrosing Interstitial Lung Diseases - a Feasibilty and Pilot Study
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : May 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention group
Intervention will be a 12 week yoga class
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.

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.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. Change in physical capacity [ Time Frame: baseline and 12 week follow-up ]
    Physical capacity will be measured by the 6 miuntes walking test

  3. 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

  4. 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).

  5. 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.

  6. Expectations of study by participants [ Time Frame: baseline ]
    Evaluation of the study by a focus group interview


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Germany
Thoraxklinik-Heidelberg
Heidelberg, Germany, 69126
Sponsors and Collaborators
Heidelberg University
Lungenfibrose e.V.
Investigators
Layout table for investigator information
Principal Investigator: Michael Kreuter, Prof. Heidelberg University
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE December 1, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Change from baseline quality of life at 12 weeks [ Time Frame: baseline and 12 week follow-up ]
    Quality of life will be measured with K-BILD-questionnaire
  • 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 [ Time Frame: 12 week follow-up ]
    Evaluation of the study by a focus group interview
  • Change from baseline quality of life at 12 weeks [ Time Frame: baseline and 12 week follow-up ]
    Quality of life will be measured with HADS-questionnaire
  • Change from baseline quality of life at 12 weeks [ Time Frame: baseline and 12 week follow-up ]
    Quality of life will be measured with ILD-questionnaire
  • Expectations of study by participants [ Time Frame: baseline ]
    Evaluation of the study by a focus group interview
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga in Patients With Fibrosing Interstitial Lung Diseases
Official Title  ICMJE Effectiveness of Yoga in Patients With Fibrosing Interstitial Lung Diseases - a Feasibilty and Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Fibrosing Interstitial Lung Diseases
  • Idiopathic Pulmonary Fibrosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention will be a 12 week yoga class
    Intervention: Other: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
20
Actual Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979703
Other Study ID Numbers  ICMJE Yoga-Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Kreuter, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Lungenfibrose e.V.
Investigators  ICMJE
Principal Investigator: Michael Kreuter, Prof. Heidelberg University
PRS Account Heidelberg University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP