NCT05946512招募中不适用
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
Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2023年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- brain imaging
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •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.
排除标准
- •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;
结局指标
主要结局
brain imaging
时间窗: 10 weeks
31P MRI
次要结局
- comparison with control groups(10 weeks)
研究者
研究点 (2)
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