Actively Recruiting
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
Led by Medical University Innsbruck · Updated on 2023-07-14
320
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Many patients with Post COVID condition experience severe and disabling shortness of breath, often without clear causes found in routine lung tests. When this shortness of breath occurs alongside symptoms like palpitations, dizziness, or anxiety, it is often labeled as dysfunctional breathing, which may be a functional symptom under somatic symptom disorder. Researchers aim to explore the psychological and physical factors behind dysfunctional breathing and study how Yoga breathing exercises may affect symptoms in people with Post COVID condition compared to healthy individuals, those with chronic obstructive lung disease (COPD), and those with somatic symptom disorder. The study evaluates two interventions: a Yoga breathing program focusing on breath-guided relaxation and a social contact group as an active comparison. Participants include people with Post COVID condition, COPD, somatic symptom disorder, and healthy volunteers. The study uses a randomized design to assign participants to either the Yoga intervention or the social contact group. The study period covers 10 weeks of intervention and observation. During the study, participants undergo brain imaging to assess changes before and after the interventions. Researchers will compare the effects of Yoga and social contact on mental and physical symptoms using various assessments. The study also monitors participants' symptom burden and physiological responses. Participation requires interaction in German for completing questionnaires and Yoga sessions, with a total involvement lasting around 10 weeks.
CONDITIONS
Brief Title
MR-spectroscopy in Post-covid Condition Prior to and Following a Yoga Breathing Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 50 years
- Persistent respiratory symptoms for at least 3 months after infection with mMRC dyspnea score ≥ 1 (for Post COVID condition group)
- Diagnosis of COPD with postbronchodilator FEV1/FVC ratio less than 0.7 and persistent respiratory symptoms for 3 months (for COPD group)
- Screening positive for somatic symptom disorder with SSD-12 score ≥ 23 and SSS-8 score ≥ 9 (for somatic symptom disorder group)
- Absence of obstructive or restrictive lung disease or unilateral diaphragmatic paresis (for Post COVID and somatic symptom disorder groups)
- Medical history with symptoms compatible with dysfunctional breathing (DB) and Nijmegen score > 23 or reduced maximal inspiratory pressure (MIP) (for Post COVID and COPD groups)
- Sufficient knowledge of German language for interaction during Yoga and completion of questionnaires
- Absence of significant active mental or somatic disorders and respiratory symptoms with mMRC < 1 (for healthy participants)
You will not qualify if you...
- Conditions preventing MRI such as metal implants, pacemakers, surgical devices, phobic anxiety, claustrophobia, or pregnancy
- Active psychiatric conditions interfering with participation such as psychosis or acute suicidality
- Severe fatigue interfering with study participation
- Evidence of structural brain abnormalities on MRI
- Significant previous meditation or Yoga experience
- Known carotid stenosis > 70% or cardiopulmonary contraindications for autonomic function tests
- Medical history of post COVID condition (for COPD, somatic symptom disorder, and healthy participants)
- Dependence on long-term oxygen therapy (for COPD participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants undergo a Yoga breathing intervention or social contact as a comparator to explore effects on brain function and respiratory symptoms.
Weekly visits for up to 10 weeks
Trial Site Locations
Total: 1 location
1
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
Research Team
P
Philipp Alexander Nelles
E
Elke Ruth Gizewski, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here