ClinicalTrials.gg
RecruitingNCT05946512SpeCYUpdated Jul 14, 2023

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

An interventional study of yoga and social contact in Post COVID-19 Condition and Somatic Symptom Disorder, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post COVID-19 Condition
  • Somatic Symptom Disorder

Keywords

  • Yoga breathing intervention
  • dysfunctional breathing
  • MR-Spectroscopy
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 320 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Eligible patients will be recruited at the Respiratory Outpatient Clinic (Medical University Innsbruck).
  2. A postbronchodilator /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 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;

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    yoga intervention

    Behavioral: yoga

  • Active comparator
    social contact

    Behavioral: social contact

Interventions

  • Behavioralyoga

    yoga breathing techniques for dysfunctional breathing

  • Behavioralsocial contact

    social contact as active comparator

06

What researchers measure

Primary outcomes

  1. brain imaging

    31P MRI

    Time frame: 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

    Time frame: 10 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2023; primary completion for Jul 2026, 36 months later.

Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 36 months is above that.

Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2023
First posted
Jul 14, 2023
StartEst.
Jul 24, 2023
Primary completionEst.
Jul 24, 2026
CompletionEst.
Jan 1, 2027
Last update
Jul 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05946512
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Jul 24, 2023 (estimated)
Primary completion
Jul 24, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jul 14, 2023

Study contacts

Philipp Alexander Nelles
Contact
philipp.nelles@tirol-kliniken.at
0505040
Elke Ruth Gizewski, Prof. Dr.
Contact
elke.gizewski@tirol-kliniken.at
0505040

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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