Official Title
MR Spectroscopy in Well-characterized Individuals With and Without Post COVID Condition Prior to and Following a Yoga Breathing Intervention- an Explorative Randomised Controlled Trial
Brief Summary

From a clinical perspective, we find that many patients with Post COVID condition sufferfrom severe and debilitating shortness of breath, while routine pulmonary investigationsfail to find the cause of the problems experienced. If dyspnea is associated withpalpitations, dizziness or anxiety, patients are commonly diagnosed with "dysfunctionalbreathing". From a psychosomatic perspective, the symptom of dysfunctional breathing canbe classified as a "functional symptom" under the umbrella term of somatic symptomdisorder. Therefore, Yoga interventions with special emphasis on breath-guided relaxationare a promising approach. We aim to investigate the psycho-somatic and somato-psychicpathophysiology on a morphological, psychological, functional and biological basisunderlying the symptom of dysfunctional breathing. Furthermore, we plan to investigatethe mechanism of Yoga intervention on the mental and somatic symptom burden ofparticipants with Post COVID condition. Then, we aim to compare the impact of Yoga onother groups - healthy individuals, patients with chronic obstructive lung disease(COPD), as well as those with somatic symptom disorder. As a control intervention to Yogaguided breathing exercises a social contact group will be used.

Detailed Description

Not Provided

Recruiting
Post COVID-19 Condition
Somatic Symptom Disorder

Behavioral: yoga

yoga breathing techniques for dysfunctional breathing

Behavioral: social contact

social contact as active comparator

Eligibility Criteria

Inclusion Criteria:

- Inclusion criteria for participants with Post COVID condition

1. Eligible patients will be recruited at the Respiratory Outpatient Clinic
(Medical University Innsbruck, Internal Medicine II) from the PRECISE registry
or from other participating clinics at Medical University Innsbruck and via
local advertisement.

2. Persistent respiratory symptoms for 3 months after infection (mMRC dyspnea
score ≥ 1).

3. Absence of obstructive or restrictive lung disease or unilateral diaphragmatic
paresis.

4. Medical history with symptoms compatible with DB as assessed by the physician
AND Nijmegen cut-off score of >23 or reduced MIP. The last two conditions were
chosen to provide a readily accessible and objectifiable entry criterion at the
inclusion visit.

5. Age >= 18 years, < 50 years.

6. Sufficient knowledge of German language for interaction during Yoga and
completion of questionnaires.

Inclusion criteria for participants with COPD

1. Eligible patients will be recruited at the Respiratory Outpatient Clinic (Medical
University Innsbruck).

2. A postbronchodilator FEV1/FVC ratio less than 0,7 obtained in functional pulmonary
testing is required fo diagnosis of COPD (Global Initiative for Chronic Obstructive
Lung Disease (GOLD) Science Committee, 2022).

3. Persistent respiratory symptoms for 3 months (mMRC≥ 1).

4. Absence of unilateral diaphragmatic paresis.

5. Medical history with symptoms compatible with DB as assessed by the physician AND
Nijmegen cut-off score of >23 or reduced MIP. The last two conditions were chosen to
provide a readily accessible and objectifiable entry criterion at the inclusion
visit.

6. Age >= 18 years, < 50 years

7. Sufficient knowledge of German language for interaction during Yoga and completion
of questionnaires

Inclusion criteria for participants with somatic symptom disorder

1. Eligible patients will be recruited at University Hospital for Psychiatry I and II,
Medical University Innsbruck) and via local advertisement.

2. Screening positive for somatic symptoms disorder with the following scores: SSD-12 ≥
23, SSS-8 ≥ 9.

3. Persistent respiratory symptoms for 3 months after infection (mMRC≥ 1).

4. Absence of obstructive or restrictive lung disease or unilateral diaphragmatic
paresis.

5. Absence of medical history with symptoms compatible with DB as assessed by the
physician AND Nijmegen cut-off score of >23 or reduced MIP. The last two conditions
were chosen to provide a readily accessible and objectifiable entry criterion at the
inclusion visit.

6. Age >= 18 years, < 50 years.

7. Sufficient knowledge of German language for interaction during Yoga and completion
of questionnaires.

Inclusion criteria for healthy participants

1. Eligible participants will be recruited via local advertisement.

2. Absence of significant active mental or somatic disorders

3. Absence of persistent respiratory symptoms (mMRC< 1).

4. Absence of obstructive or restrictive lung disease or unilateral diaphragmatic
paresis.

5. Absence of medical history with symptoms compatible with DB as assessed by the
physician AND Nijmegen questionnaire and MIP within normal limits..

6. Age >= 18 years, < 50 years.

7. Sufficient knowledge of German language for interaction during Yoga and completion
of questionnaires.

Exclusion Criteria:

- Exclusion criteria for participants with post COVID condition

1. Conditions precluding magnetic resonance imaging (MRI) such as metal implants
in the body (e.g., pacemakers, surgical devices), phobic anxiety,
claustrophobia, or pregnancy.

2. Active psychiatric conditions interfering with study participation such as
psychosis or acute suicidality.

3. Severe fatigue interfering with study participation.

4. Previous evidence of structural brain abnormality on the structural MRI scan.

5. Significant previous meditation or Yoga experience.

6. Patients with known carotid stenosis >70% or cardiopulmonary contraindications
for tilt table and other cardiovascular autonomic function tests (e.g. Valsalva
maneuver, deep breathing, standing test).

Exclusion criteria for participants with COPD

1. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the
body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or
pregnancy.

2. Active psychiatric conditions interfering with study participation such as psychosis
or acute suicidality.

3. Severe fatigue interfering with study participation.

4. Previous evidence of structural brain abnormality on the structural MRI scan.

5. Medical history of post COVID condition.

6. Significant previous meditation or Yoga experience.

7. Patients with known carotid stenosis >70% or cardiopulmonary contraindications for
tilt table and other cardiovascular autonomic function tests (e.g. Valsalva
maneuver, deep breathing, standing test).

8. Patients dependent on a long-term oxygen therapy (LTOT )

Exclusion criteria for participants with somatic symptom disorder

1. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the
body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or
pregnancy.

2. Other active psychiatric conditions interfering with study participation such as
psychosis or acute suicidality.

3. Severe fatigue interfering with study participation.

4. Previous evidence of structural brain abnormality on the structural MRI scan.

5. Medical history of post COVID condition.

6. Significant previous meditation or Yoga experience.

7. Patients with known carotid stenosis >70% or cardiopulmonary contraindications for
tilt table and other cardiovascular autonomic function tests (e.g. Valsalva
maneuver, deep breathing, standing test).

Exclusion criteria for healthy participants

1. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the
body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or
pregnancy.

2. Active psychiatric conditions interfering with study participation such as psychosis
or acute suicidality.

3. Previous evidence of structural brain abnormality on the structural MRI scan.

4. Medical history of post COVID condition.

5. Significant previous meditation or Yoga experience.

6. Patients with known carotid stenosis >70% or cardiopulmonary contraindications for
tilt table and other cardiovascular autonomic function tests (e.g. Valsalva
maneuver, deep breathing, standing test).

legend: PRECISE = a study conducted with participants with post-COVID-19 condition at the
Medical University of Innsbruck; mMRC score = modified medical research council score; DB
= dysfunctional breathing; MIP = maximal inspiratory pressure; COPD = chronic obstructive
pulmonary disease; FEV1/FVC = forced expiratory volume in one second/ forced vital
capacity; SSD-12 = Somatic Symptom Disorder - B Criteria Scale; SSS-8 = Somatic Symptom
Scale - 8;

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
Austria
Locations

Medizinische Universität Innsbruck
Innsbruck, Tirol, Austria

Investigator: Philipp Nelles
Contact: 0505040
philipp.nelles@tirol-kliniken.at

Contacts

Philipp Alexander Nelles
0505040
philipp.nelles@tirol-kliniken.at

Elke Ruth Gizewski, Prof. Dr.
0505040
elke.gizewski@tirol-kliniken.at

Not Provided

Medical University Innsbruck
NCT Number
Keywords
Yoga breathing intervention
dysfunctional breathing
MR-Spectroscopy
MeSH Terms
Respiratory Aspiration
Disease
Medically Unexplained Symptoms