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临床试验/NCT06394921
NCT06394921已完成不适用

Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study

Sheffield Hallam University5 个研究点 分布在 3 个国家目标入组 146 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
5
主要终点
Cardiopulmonary Exercise Test- Minute Ventilation

研究概览

简要总结

The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Aged 18 to 65 years old
  • Diagnosed with COVID-19
  • Still suffering from symptoms of COVID-19, 3 months after initial infection
  • Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.

排除标准

  • • <18 years of age
  • Admitted to or received treatment from Intensive Care Units
  • Unconfirmed COVID-19 test diagnosis
  • Unable to understand verbal or written information in English
  • Achieving a grade 0 or 1 on the PCFS.
  • Unstable angina
  • Uncontrolled hypertension, that is, resting systolic blood pressure (SBP) >180mmHg, or resting diastolic blood pressure (BP) (DBP) >110mmHg
  • Orthostatic blood pressure drop of >20 mmHg with symptoms
  • Significant aortic stenosis (aortic valve area 120 bpm)
  • Acute pericarditis or myocarditis
  • Decompensated HF
  • Third degree (complete) atrioventricular (AV) block without pacemaker
  • Recent embolism
  • Acute thrombophlebitis
  • Resting ST segment displacement (>2 mm)
  • Uncontrolled diabetes mellitus
  • Severe orthopaedic conditions that would prohibit exercise
  • Other metabolic conditions, such as acute thyroiditis, hypokalaemia, hyperkalaemia or hypovolaemia (until adequately treated)
  • Severe grade 3 rejection (cardiac transplantation recipients Appendix N).

结局指标

主要结局

Cardiopulmonary Exercise Test- Minute Ventilation

时间窗: During CPET1 and CPET2

Minute Ventilation using breath by breath (l/min)

Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation

时间窗: During CPET1 and CPET2

Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min)

Cardiopulmonary Exercise Test- Respiratory Threshold

时间窗: During CPET1 and CPET2

Respiratory Threshold breath by breath (l/min)

Prevalence of symptoms of post exertional Malaise

时间窗: 7 days post exercise

Symptom Profile post exercise protocols- Questionnaire

Cardiopulmonary Exercise Test- Respiratory Exchange Ratio

时间窗: During CPET1 and CPET2

Respiratory Exchange Ratio (VO2/VCO2)

Cardiopulmonary Exercise Test- Blood lactate

时间窗: During CPET1 and CPET2

Blood Lactate Concentration from fingertip (mmol/l)

Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation

时间窗: During CPET1 and CPET2

Rate of Oxygen Utilisation (VO2; l/min)

Cardiopulmonary Exercise Test- Rate of carbon dioxide production

时间窗: During CPET1 and CPET2

Rate of Carbon Dioxide Production (VCO2; l/min)

次要结局

  • Blood biomarkers of Inflammation- IL-6(Day 1 and Day 2)
  • Blood biomarkers of Inflammation- Microclots(Day 1 and Day 2)
  • Blood biomarkers of Inflammation- CRP(Day 1 and Day 2)
  • Exercise Diastolic Blood Pressure(Baseline, Day 1 and Day 2)
  • Exercise Systolic Blood Pressure(Baseline, Day 1 and Day 2)
  • Resting Diastolic Blood Pressure(Baseline, Day 1 and Day 2)
  • Blood biomarkers of Inflammation- D-Dimer(Day 1 and Day 2)
  • Blood biomarkers of Inflammation- IL-1(Day 1 and Day 2)
  • Echocardiogram(Baseline, Day 1 and Day 2)
  • Resting Systolic Blood Pressure(Baseline, Day 1 and Day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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