MR-spectroscopy in Post-covid Condition Prior to and Following a Yoga Breathing Intervention

Last updated: July 13, 2023
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypochondriasis

Somatoform And Dissociative Disorders

Functional Dyspepsia

Treatment

social contact

yoga

Clinical Study ID

NCT05946512
1034/2023
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

From a clinical perspective, we find that many patients with Post COVID condition suffer from severe and debilitating shortness of breath, while routine pulmonary investigations fail to find the cause of the problems experienced. If dyspnea is associated with palpitations, dizziness or anxiety, patients are commonly diagnosed with "dysfunctional breathing". From a psychosomatic perspective, the symptom of dysfunctional breathing can be classified as a "functional symptom" under the umbrella term of somatic symptom disorder. Therefore, Yoga interventions with special emphasis on breath-guided relaxation are a promising approach. We aim to investigate the psycho-somatic and somato-psychic pathophysiology on a morphological, psychological, functional and biological basis underlying the symptom of dysfunctional breathing. Furthermore, we plan to investigate the mechanism of Yoga intervention on the mental and somatic symptom burden of participants with Post COVID condition. Then, we aim to compare the impact of Yoga on other groups - healthy individuals, patients with chronic obstructive lung disease (COPD), as well as those with somatic symptom disorder. As a control intervention to Yoga guided breathing exercises a social contact group will be used.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria for participants with Post COVID condition
  1. Eligible patients will be recruited at the Respiratory Outpatient Clinic (MedicalUniversity Innsbruck, Internal Medicine II) from the PRECISE registry or fromother participating clinics at Medical University Innsbruck and via localadvertisement.
  2. Persistent respiratory symptoms for 3 months after infection (mMRC dyspnea score ≥ 1).
  3. Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
  4. Medical history with symptoms compatible with DB as assessed by the physician ANDNijmegen cut-off score of >23 or reduced MIP. The last two conditions were chosento provide a readily accessible and objectifiable entry criterion at theinclusion visit.
  5. Age >= 18 years, < 50 years.
  6. Sufficient knowledge of German language for interaction during Yoga andcompletion of questionnaires. Inclusion criteria for participants with COPD
  7. Eligible patients will be recruited at the Respiratory Outpatient Clinic (MedicalUniversity Innsbruck).
  8. A postbronchodilator FEV1/FVC ratio less than 0,7 obtained in functional pulmonarytesting is required fo diagnosis of COPD (Global Initiative for Chronic ObstructiveLung Disease (GOLD) Science Committee, 2022).
  9. Persistent respiratory symptoms for 3 months (mMRC≥ 1).
  10. Absence of unilateral diaphragmatic paresis.
  11. Medical history with symptoms compatible with DB as assessed by the physician ANDNijmegen cut-off score of >23 or reduced MIP. The last two conditions were chosen toprovide a readily accessible and objectifiable entry criterion at the inclusion visit.
  12. Age >= 18 years, < 50 years
  13. Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires Inclusion criteria for participants with somatic symptom disorder
  14. Eligible patients will be recruited at University Hospital for Psychiatry I and II,Medical University Innsbruck) and via local advertisement.
  15. Screening positive for somatic symptoms disorder with the following scores: SSD-12 ≥ 23, SSS-8 ≥ 9.
  16. Persistent respiratory symptoms for 3 months after infection (mMRC≥ 1).
  17. Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
  18. Absence of medical history with symptoms compatible with DB as assessed by thephysician AND Nijmegen cut-off score of >23 or reduced MIP. The last two conditionswere chosen to provide a readily accessible and objectifiable entry criterion at theinclusion visit.
  19. Age >= 18 years, < 50 years.
  20. Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires. Inclusion criteria for healthy participants
  21. Eligible participants will be recruited via local advertisement.
  22. Absence of significant active mental or somatic disorders
  23. Absence of persistent respiratory symptoms (mMRC< 1).
  24. Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
  25. Absence of medical history with symptoms compatible with DB as assessed by thephysician AND Nijmegen questionnaire and MIP within normal limits..
  26. Age >= 18 years, < 50 years.
  27. Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires.

Exclusion

Exclusion Criteria:

  • Exclusion criteria for participants with post COVID condition
  1. Conditions precluding magnetic resonance imaging (MRI) such as metal implants inthe body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
  2. Active psychiatric conditions interfering with study participation such aspsychosis 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 contraindicationsfor tilt table and other cardiovascular autonomic function tests (e.g. Valsalvamaneuver, deep breathing, standing test). Exclusion criteria for participants with COPD
  7. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
  8. Active psychiatric conditions interfering with study participation such as psychosisor acute suicidality.
  9. Severe fatigue interfering with study participation.
  10. Previous evidence of structural brain abnormality on the structural MRI scan.
  11. Medical history of post COVID condition.
  12. Significant previous meditation or Yoga experience.
  13. Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt table and other cardiovascular autonomic function tests (e.g. Valsalva maneuver,deep breathing, standing test).
  14. Patients dependent on a long-term oxygen therapy (LTOT ) Exclusion criteria for participants with somatic symptom disorder
  15. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
  16. Other active psychiatric conditions interfering with study participation such aspsychosis or acute suicidality.
  17. Severe fatigue interfering with study participation.
  18. Previous evidence of structural brain abnormality on the structural MRI scan.
  19. Medical history of post COVID condition.
  20. Significant previous meditation or Yoga experience.
  21. Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt table and other cardiovascular autonomic function tests (e.g. Valsalva maneuver,deep breathing, standing test). Exclusion criteria for healthy participants
  22. Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
  23. Active psychiatric conditions interfering with study participation such as psychosisor acute suicidality.
  24. Previous evidence of structural brain abnormality on the structural MRI scan.
  25. Medical history of post COVID condition.
  26. Significant previous meditation or Yoga experience.
  27. Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt 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 theMedical University of Innsbruck; mMRC score = modified medical research council score; DB =dysfunctional breathing; MIP = maximal inspiratory pressure; COPD = chronic obstructivepulmonary disease; FEV1/FVC = forced expiratory volume in one second/ forced vitalcapacity; SSD-12 = Somatic Symptom Disorder - B Criteria Scale; SSS-8 = Somatic SymptomScale - 8;

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: social contact
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Medizinische Universität Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Active - Recruiting

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