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| Name | Class |
|---|---|
| MS Ramaiah Medical College & Hospitals | OTHER |
| University of Illinois at Chicago | OTHER |
| University of Nottingham | OTHER |
| Northumbria University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Long COVID | Eligibility
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 day cardiopulmonary exercise test | Procedure | Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation | Rate of Oxygen Utilisation (VO2; l/min) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test- Rate of carbon dioxide production | Rate of Carbon Dioxide Production (VCO2; l/min) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test- Respiratory Exchange Ratio | Respiratory Exchange Ratio (VO2/VCO2) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation | Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test- Respiratory Threshold | Respiratory Threshold breath by breath (l/min) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test- Minute Ventilation | Minute Ventilation using breath by breath (l/min) | During CPET1 and CPET2 |
| Cardiopulmonary Exercise Test- Blood lactate | Blood Lactate Concentration from fingertip (mmol/l) | During CPET1 and CPET2 |
| Prevalence of symptoms of post exertional Malaise |
| Measure | Description | Time Frame |
|---|---|---|
| Blood biomarkers of Inflammation- IL-6 | Concentration of Interleukin 6 | Day 1 and Day 2 |
| Blood biomarkers of Inflammation- IL-1 | Concentration of Interleukin 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Profile Questionnaire | Description of previous and current symptom/s of Long COVID | Baseline |
| Quality of Life questionnaire | EQ-5D-5L |
Inclusion Criteria:
• Aged 18 to 65 years old
Exclusion Criteria:
• <18 years of age
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Patients will be assessed according to the eligibility criteria and recruited directly from Long COVID Clinics in the UK (Derbyshire Community Health Services, Sheffield Teaching Hospitals NHS Foundation Trust and Northumbria NHS Trust), the University of Illinois Post-COVID-19 Clinic, (Chicago, USA) and the Ramiah Medical Centre Post COVID Centre (Bangalore, India). Long COVID patients will be assessed according to the eligibility criteria and recruited following referral or contact with a long COVID clinic or having suspected or confirmed long COVID. Social media and targeted recruitment from established pages will be used to advertise the opportunity to engage with the trial for those in proximity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60607 | United States | ||
| Ramaiah Medical College |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2023 | Mar 26, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| King's College London | OTHER |
| University of Derby | OTHER |
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Blood plasma samples
Symptom Profile post exercise protocols- Questionnaire
| 7 days post exercise |
| Day 1 and Day 2 |
| Blood biomarkers of Inflammation- Microclots | Number of Microclots | Day 1 and Day 2 |
| Blood biomarkers of Inflammation- D-Dimer | D-Dimer Concentration | Day 1 and Day 2 |
| Blood biomarkers of Inflammation- CRP | C-Reactive protein Concentration | Day 1 and Day 2 |
| Echocardiogram | 12 lead echocardiogram. | Baseline, Day 1 and Day 2 |
| Resting Systolic Blood Pressure | Systolic Blood Pressure at Rest (mmHg) | Baseline, Day 1 and Day 2 |
| Resting Diastolic Blood Pressure | Diastolic Blood Pressure at Rest (mmHg) | Baseline, Day 1 and Day 2 |
| Exercise Diastolic Blood Pressure | Diastolic Blood Pressure During Exercise (mmHg) | Baseline, Day 1 and Day 2 |
| Exercise Systolic Blood Pressure | Systolic Blood Pressure During Exercise (mmHg) | Baseline, Day 1 and Day 2 |
| Baseline |
| Sleep Behavour | Pittsburgh Sleep Quality Index | Baseline |
| Fatigue Questionnaire- FAS | Fatigue Assessment Scale | Baseline, Day 1 and Day 2 |
| Fatigue Questionnaire- MFI | Multidimensional Fatigue Index (MFI-20) | Baseline, Day 1 and Day 2 |
| Medical Research Council Dyspnoea Scale | Breathlessness scale | Baseline |
| Post COVID-19 functional status Scale | Questionnaire to see effect of COVID-19 on physical function- 0= No Limitations; 4- Severe Limitations to function | Baseline |
| Cognition | Montreal cognitive assessment | Baseline |
| 6 minute walk | 6 minute walk distance (metres) | Baseline |
| Timed Up and Go | 5m timed up and go (seconds) | Baseline |
| Lung Function Assessment- FEV1 | Forced Expiratory Volume in 1 Second (l) | Baseline |
| Lung Function Assessment- FVC | Forced Vital Capacity (l) | Baseline |
| Lung Function Assessment- PEF | Peak Expiratory Flow Rate (l/min) | Baseline |
| Lung Function Assessment- MIP | Maximal Inspiratory Pressure (mmHg) | Baseline |
| Lung Function Assessment- MEP | Maximal Expiratory Pressure (mmHg) | Baseline |
| Height | measurement of body stature (m) | Baseline |
| Weight | Measurement of body mass (kg) | Baseline |
| body mass index | weight and height will be combined to report BMI in kg/m^2 | Baseline |
| Bengaluru |
| India |
| University of Derby | Derby | Derbyshire | United Kingdom |
| Sheffield Hallam University | Sheffield | South Yorkshire | United Kingdom |
| Northumbria University | Newcastle upon Tyne | United Kingdom |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |