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 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.
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 →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.
Inclusion Criteria:
Inclusion criteria for participants with Post COVID condition
Inclusion criteria for participants with
Inclusion criteria for participants with somatic symptom disorder
Inclusion criteria for healthy participants
Exclusion Criteria:
Exclusion criteria for participants with post COVID condition
Exclusion criteria for participants with COPD
Exclusion criteria for participants with somatic symptom disorder
Exclusion criteria for healthy participants
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;
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: yoga
Behavioral: social contact
yoga breathing techniques for dysfunctional breathing
social contact as active comparator
brain imaging
31P MRI
Time frame: 10 weeks
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
Plan to share: No
No publications or documents are linked to this record.
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.
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