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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05946512
Acronym
SpeCY
Enrollment
320
Registered
2023-07-14
Start date
2023-07-24
Completion date
2027-01-01
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post COVID-19 Condition, Somatic Symptom Disorder

Keywords

Yoga breathing intervention, dysfunctional breathing, MR-Spectroscopy

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.

Interventions

BEHAVIORALyoga

yoga breathing techniques for dysfunctional breathing

BEHAVIORALsocial contact

social contact as active comparator

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
brain imaging10 weeks31P MRI

Secondary

MeasureTime frameDescription
comparison with control groups10 weeksresting state functional MRI (rs-MRI),diaphragmatic function in spirometry and MRI, laboratory analyses, autonomic testing, questionnaires

Countries

Austria

Contacts

Primary ContactPhilipp Alexander Nelles
philipp.nelles@tirol-kliniken.at0505040
Backup ContactElke Ruth Gizewski, Prof. Dr.
elke.gizewski@tirol-kliniken.at0505040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026