Investigating yoga breathing for post-COVID symptoms

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

This study tests if yoga breathing exercises can help people with post-COVID symptoms and breathing issues feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Medical University Innsbruck (Academic / other)
• Locations: 1 site (Innsbruck, Tyrol)
• Trial ID: NCT05946512 on ClinicalTrials.gov

What this trial studies

This study explores the effects of a yoga breathing intervention on patients suffering from post-COVID condition and dysfunctional breathing. It aims to understand the psycho-somatic and somato-psychic mechanisms underlying these symptoms through MR-spectroscopy and other assessments. Participants will engage in yoga sessions focused on breath-guided relaxation, while their respiratory symptoms and psychological well-being will be monitored before and after the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with persistent respiratory symptoms following COVID-19 and a diagnosis of dysfunctional breathing.

Not a fit: Patients with obstructive or restrictive lung diseases or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly alleviate debilitating respiratory symptoms in post-COVID patients.

How similar studies have performed: While the specific combination of yoga breathing and MR-spectroscopy is novel, similar interventions have shown promise in managing respiratory symptoms and anxiety in other populations.

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;

Where this trial is running

Innsbruck, Tyrol

• Medizinische Universität Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)

Study contacts

• Study coordinator: Philipp Alexander Nelles

Conditions Post COVID-19 Condition; Somatic Symptom Disorder; Yoga breathing intervention; dysfunctional breathing; MR-Spectroscopy