Yoga in Patients With Fibrosing Interstitial Lung Diseases

NCT03979703 | Completed

• 1 other identifier: Yoga-Study
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosing Interstitial Lung Diseases; Idiopathic Pulmonary Fibrosis

Keywords

fibrosing interstitial lung disease; Idiopathic Pulmonary Fibrosis; Yoga

Outcome Measures

Primary Outcomes (6)

• 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.

  baseline and 12 week follow-up

• Change in physical capacity

  Physical capacity will be measured by the 6 miuntes walking test

  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

  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).

  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.

  baseline and 12 week follow-up

• Expectations of study by participants

  Evaluation of the study by a focus group interview

  baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention will be a 12 week yoga class

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.

Interventions

12 week yoga class OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to understand study and study procedure
• diagnosis of fibrosing interstitial lung disease
• Age: \> 18 years
• Ability to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Lungenfibrose e.V.: collaborator

Study Sites (1)

Thoraxklinik-Heidelberg

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Kreuter, Prof.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 7, 2019
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)