Post COVID-19 ConditionSpeCYNCT05946512
MR-spectroscopy in Post-covid Condition Prior to and Following a Yoga Breathing Intervention
A study testing yoga and social contact in people with Post COVID-19 Condition and Somatic Symptom Disorder, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post COVID-19 Condition, Somatic Symptom Disorder
- What is being tested?
- yoga and social contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteAustria
- Study dates
- 24 Jul 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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 )
- 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).
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020
Philipp Nelles, 0505040, philipp.nelles@tirol-kliniken.at
About this study
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
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
- Being tested
- yoga, social contact
- Keywords
- Yoga breathing intervention, dysfunctional breathing, MR-Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
yoga breathing techniques for dysfunctional breathing
social contactBehavioural
social contact as active comparator
| Study group | Role | What they receive |
|---|---|---|
| yoga intervention | Experimental | Not described Receives: Behavioral: yoga |
| social contact | Active comparator | Not described Receives: Behavioral: social contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain imaging
31P MRI
Measured: 10 weeks
Secondary outcomes (1)
comparison with control groups
resting state functional MRI (rs-MRI),diaphragmatic function in spirometry and MRI, laboratory analyses, autonomic testing, questionnaires
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start24 Jul 2023 (estimated)
- Primary completion24 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946512
- Sponsor's protocol ID
- 1034/2023
- Acronym
- SpeCY
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05946512
- Acronym / sponsor ID
- SpeCY / 1034/2023
- Conditions
- Post COVID-19 Condition, Somatic Symptom Disorder
- Keywords
- Yoga breathing intervention, dysfunctional breathing, MR-Spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 24 Jul 2023 (estimated)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga intervention | Experimental | Behavioral: yoga |
| social contact | Active comparator | Behavioral: social contact |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- Inclusion criteria for participants with Post COVID condition
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yogayoga breathing techniques for dysfunctional breathing | Behavioural | yoga intervention |
| social contactsocial contact as active comparator | Behavioural | social contact |
Primary outcome
brain imaging
Time frame: 10 weeks
31P MRI
1 secondary outcome
comparison with control groups
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga and social contact in people with Post COVID-19 Condition and Somatic Symptom Disorder, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Alexander Nelles (0505040, philipp.nelles@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain imaging (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.