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

Primary Purpose

Post COVID-19 Condition, Somatic Symptom Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
yoga
social contact
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post COVID-19 Condition focused on measuring Yoga breathing intervention, dysfunctional breathing, MR-Spectroscopy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Inclusion criteria for participants with Post COVID condition 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. 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. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Inclusion criteria for participants with COPD 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. 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. Age >= 18 years, < 50 years Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires Inclusion criteria for participants with somatic symptom disorder 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. 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. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Inclusion criteria for healthy participants Eligible participants will be recruited via local advertisement. Absence of significant active mental or somatic disorders Absence of persistent respiratory symptoms (mMRC< 1). Absence of obstructive or restrictive lung disease or unilateral diaphragmatic paresis. Absence of medical history with symptoms compatible with DB as assessed by the physician AND Nijmegen questionnaire and MIP within normal limits.. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Exclusion Criteria: Exclusion criteria for participants with post COVID condition 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). Exclusion criteria for participants with COPD 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 ) Exclusion criteria for participants with somatic symptom disorder Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or pregnancy. Other 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). Exclusion criteria for healthy participants 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. 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). 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;

Sites / Locations

  • Medizinische Universität InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

yoga intervention

social contact

Arm Description

Outcomes

Primary Outcome Measures

brain imaging
31P MRI

Secondary Outcome Measures

comparison with control groups
resting state functional MRI (rs-MRI),diaphragmatic function in spirometry and MRI, laboratory analyses, autonomic testing, questionnaires

Full Information

First Posted
July 13, 2023
Last Updated
July 13, 2023
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT05946512
Brief Title
MR-spectroscopy in Post-covid Condition Prior to and Following a Yoga Breathing Intervention
Acronym
SpeCY
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Anticipated)
Primary Completion Date
July 24, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19 Condition, Somatic Symptom Disorder
Keywords
Yoga breathing intervention, dysfunctional breathing, MR-Spectroscopy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
yoga intervention
Arm Type
Experimental
Arm Title
social contact
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
yoga
Intervention Description
yoga breathing techniques for dysfunctional breathing
Intervention Type
Behavioral
Intervention Name(s)
social contact
Intervention Description
social contact as active comparator
Primary Outcome Measure Information:
Title
brain imaging
Description
31P MRI
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
comparison with control groups
Description
resting state functional MRI (rs-MRI),diaphragmatic function in spirometry and MRI, laboratory analyses, autonomic testing, questionnaires
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for participants with Post COVID condition 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. 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. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Inclusion criteria for participants with COPD 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. 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. Age >= 18 years, < 50 years Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires Inclusion criteria for participants with somatic symptom disorder 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. 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. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Inclusion criteria for healthy participants Eligible participants will be recruited via local advertisement. Absence of significant active mental or somatic disorders Absence of persistent respiratory symptoms (mMRC< 1). Absence of obstructive or restrictive lung disease or unilateral diaphragmatic paresis. Absence of medical history with symptoms compatible with DB as assessed by the physician AND Nijmegen questionnaire and MIP within normal limits.. Age >= 18 years, < 50 years. Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires. Exclusion Criteria: Exclusion criteria for participants with post COVID condition 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). Exclusion criteria for participants with COPD 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 ) Exclusion criteria for participants with somatic symptom disorder Conditions precluding magnetic resonance imaging (MRI) such as metal implants in the body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, or pregnancy. Other 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). Exclusion criteria for healthy participants 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. 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). 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Alexander Nelles
Phone
0505040
Email
philipp.nelles@tirol-kliniken.at
First Name & Middle Initial & Last Name or Official Title & Degree
Elke Ruth Gizewski, Prof. Dr.
Phone
0505040
Email
elke.gizewski@tirol-kliniken.at
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Nelles
Phone
0505040
Email
philipp.nelles@tirol-kliniken.at

12. IPD Sharing Statement

Plan to Share IPD
No

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

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