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

NCT05946512 | Recruiting

• 1 other identifier: 1034/2023
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post COVID-19 Condition; Somatic Symptom Disorder

Keywords

Yoga breathing intervention; dysfunctional breathing; MR-Spectroscopy

Outcome Measures

Primary Outcomes (1)

• brain imaging

  31P MRI

  10 weeks

Secondary Outcomes (1)

• comparison with control groups

  10 weeks

Study Arms (2)

yoga intervention

EXPERIMENTAL

Behavioral: yoga

social contact

ACTIVE COMPARATOR

Behavioral: social contact

Interventions

yoga BEHAVIORAL

yoga breathing techniques for dysfunctional breathing

yoga intervention

social contact BEHAVIORAL

social contact as active comparator

social contact

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Persistent respiratory symptoms for 3 months after infection (mMRC dyspnea score ≥ 1).
• Absence of obstructive or restrictive lung disease or unilateral diaphragmatic paresis.
• Age \>= 18 years, \< 50 years.
• Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires.
• Eligible patients will be recruited at the Respiratory Outpatient Clinic (Medical University Innsbruck).
• 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).
• Persistent respiratory symptoms for 3 months (mMRC≥ 1).
• Absence of unilateral diaphragmatic paresis.
• Age \>= 18 years, \< 50 years
• Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires
• Eligible patients will be recruited at University Hospital for Psychiatry I and II, Medical University Innsbruck) and via local advertisement.
• Screening positive for somatic symptoms disorder with the following scores: SSD-12 ≥ 23, SSS-8 ≥ 9.
• Persistent respiratory symptoms for 3 months after infection (mMRC≥ 1).
• Absence of obstructive or restrictive lung disease or unilateral diaphragmatic paresis.

You may not qualify if:

• Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or pregnancy.
• Active psychiatric conditions interfering with study participation such as psychosis or acute suicidality.
• Severe fatigue interfering with study participation.
• Previous evidence of structural brain abnormality on the structural MRI scan.
• Significant previous meditation or Yoga experience.
• 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).
• Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or pregnancy.
• Active psychiatric conditions interfering with study participation such as psychosis or acute suicidality.
• Severe fatigue interfering with study participation.
• Previous evidence of structural brain abnormality on the structural MRI scan.
• Medical history of post COVID condition.
• Significant previous meditation or Yoga experience.
• 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).
• Patients dependent on a long-term oxygen therapy (LTOT )
• Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or pregnancy.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Philipp Alexander Nelles

CONTACT

0505040; philipp.nelles@tirol-kliniken.at

Elke Ruth Gizewski, Prof. Dr.

CONTACT

0505040; elke.gizewski@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 14, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)