Cardiopulmonary Exercise Tests in Patients With Long COVID
- Conditions
- Long COVIDCOVID Long-Haul
- Interventions
- Procedure: 2 day cardiopulmonary exercise test
- Registration Number
- NCT06394921
- Lead Sponsor
- Sheffield Hallam University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
-
• 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.
-
• <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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description People with Long COVID 2 day cardiopulmonary exercise test Eligibility * Aged 18 to 65 years old * Diagnosed with COVID-19 * Still suffering from symptoms and experiencing functional limitations beyond 3 months after initial COVID-19 infection (quantified as PCFS grade 1 or greater). * Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.
- Primary Outcome Measures
Name Time Method Cardiopulmonary Exercise Test- Minute Ventilation During CPET1 and CPET2 Minute Ventilation using breath by breath (l/min)
Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation During CPET1 and CPET2 Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min)
Cardiopulmonary Exercise Test- Respiratory Threshold During CPET1 and CPET2 Respiratory Threshold breath by breath (l/min)
Prevalence of symptoms of post exertional Malaise 7 days post exercise Symptom Profile post exercise protocols- Questionnaire
Cardiopulmonary Exercise Test- Respiratory Exchange Ratio During CPET1 and CPET2 Respiratory Exchange Ratio (VO2/VCO2)
Cardiopulmonary Exercise Test- Blood lactate During CPET1 and CPET2 Blood Lactate Concentration from fingertip (mmol/l)
Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation During CPET1 and CPET2 Rate of Oxygen Utilisation (VO2; l/min)
Cardiopulmonary Exercise Test- Rate of carbon dioxide production During CPET1 and CPET2 Rate of Carbon Dioxide Production (VCO2; l/min)
- Secondary Outcome Measures
Name Time Method Echocardiogram Baseline, Day 1 and Day 2 12 lead echocardiogram.
Blood biomarkers of Inflammation- IL-6 Day 1 and Day 2 Concentration of Interleukin 6
Blood biomarkers of Inflammation- Microclots Day 1 and Day 2 Number of Microclots
Blood biomarkers of Inflammation- CRP Day 1 and Day 2 C-Reactive protein Concentration
Exercise Diastolic Blood Pressure Baseline, Day 1 and Day 2 Diastolic Blood Pressure During Exercise (mmHg)
Exercise Systolic Blood Pressure Baseline, Day 1 and Day 2 Systolic Blood Pressure During Exercise (mmHg)
Blood biomarkers of Inflammation- D-Dimer Day 1 and Day 2 D-Dimer Concentration
Resting Diastolic Blood Pressure Baseline, Day 1 and Day 2 Diastolic Blood Pressure at Rest (mmHg)
Blood biomarkers of Inflammation- IL-1 Day 1 and Day 2 Concentration of Interleukin 1
Resting Systolic Blood Pressure Baseline, Day 1 and Day 2 Systolic Blood Pressure at Rest (mmHg)
Trial Locations
- Locations (5)
University of Derby
🇬🇧Derby, Derbyshire, United Kingdom
Ramaiah Medical College
🇮🇳Bengaluru, India
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Sheffield Hallam University
🇬🇧Sheffield, South Yorkshire, United Kingdom
Northumbria University
🇬🇧Newcastle Upon Tyne, United Kingdom