COVID Long-Haul, Long COVID
Conditions
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.
Interventions
PROCEDURE2 day cardiopulmonary exercise test
Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue.
Sponsors
MS Ramaiah Medical College & Hospitals
University of Illinois at Chicago
University of Nottingham
Northumbria University
King's College London
University of Derby
Sheffield Hallam University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* • 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.
Exclusion criteria
* • \<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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation | During CPET1 and CPET2 | Rate of Oxygen Utilisation (VO2; l/min) |
| Prevalence of symptoms of post exertional Malaise | 7 days post exercise | Symptom Profile post exercise protocols- Questionnaire |
| Cardiopulmonary Exercise Test- Blood lactate | During CPET1 and CPET2 | Blood Lactate Concentration from fingertip (mmol/l) |
| Cardiopulmonary Exercise Test- Minute Ventilation | During CPET1 and CPET2 | Minute Ventilation using breath by breath (l/min) |
| Cardiopulmonary Exercise Test- Respiratory Threshold | During CPET1 and CPET2 | Respiratory Threshold 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 Exchange Ratio | During CPET1 and CPET2 | Respiratory Exchange Ratio (VO2/VCO2) |
| Cardiopulmonary Exercise Test- Rate of carbon dioxide production | During CPET1 and CPET2 | Rate of Carbon Dioxide Production (VCO2; l/min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarkers of Inflammation- IL-6 | Day 1 and Day 2 | Concentration of Interleukin 6 |
| Blood biomarkers of Inflammation- IL-1 | Day 1 and Day 2 | Concentration of Interleukin 1 |
| Blood biomarkers of Inflammation- Microclots | Day 1 and Day 2 | Number of Microclots |
| Blood biomarkers of Inflammation- D-Dimer | Day 1 and Day 2 | D-Dimer Concentration |
| Blood biomarkers of Inflammation- CRP | Day 1 and Day 2 | C-Reactive protein Concentration |
| Echocardiogram | Baseline, Day 1 and Day 2 | 12 lead echocardiogram. |
| Resting Systolic Blood Pressure | Baseline, Day 1 and Day 2 | Systolic Blood Pressure at Rest (mmHg) |
| Resting Diastolic Blood Pressure | Baseline, Day 1 and Day 2 | Diastolic Blood Pressure at Rest (mmHg) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptom Profile Questionnaire | Baseline | Description of previous and current symptom/s of Long COVID |
| Quality of Life questionnaire | Baseline | EQ-5D-5L |
| 6 minute walk | Baseline | 6 minute walk distance (metres) |
| Cognition | Baseline | Montreal cognitive assessment |
| Post COVID-19 functional status Scale | Baseline | Questionnaire to see effect of COVID-19 on physical function- 0= No Limitations; 4- Severe Limitations to function |
| Medical Research Council Dyspnoea Scale | Baseline | Breathlessness scale |
| Fatigue Questionnaire- MFI | Baseline, Day 1 and Day 2 | Multidimensional Fatigue Index (MFI-20) |
| Fatigue Questionnaire- FAS | Baseline, Day 1 and Day 2 | Fatigue Assessment Scale |
| Sleep Behavour | Baseline | Pittsburgh Sleep Quality Index |
| Timed Up and Go | Baseline | 5m timed up and go (seconds) |
| Lung Function Assessment- FEV1 | Baseline | Forced Expiratory Volume in 1 Second (l) |
| Lung Function Assessment- FVC | Baseline | Forced Vital Capacity (l) |
| Lung Function Assessment- PEF | Baseline | Peak Expiratory Flow Rate (l/min) |
| Lung Function Assessment- MIP | Baseline | Maximal Inspiratory Pressure (mmHg) |
| Lung Function Assessment- MEP | Baseline | Maximal Expiratory Pressure (mmHg) |
| Height | Baseline | measurement of body stature (m) |
| Weight | Baseline | Measurement of body mass (kg) |
| body mass index | Baseline | weight and height will be combined to report BMI in kg/m\^2 |
Countries
India, United Kingdom, United States
Outcome results
None listed