Cardiopulmonary Exercise Tests in Patients With Long COVID

Long COVID Clinical Trial

— PREPP-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394921
• Other study ID #: PREPP19
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: Sheffield Hallam University
• Contact: Mark Faghy, PhD
• Phone: 01332 592109
• Email: m.a.faghy[@]derby.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Long COVID

Intervention

Procedure:
• 2 day cardiopulmonary exercise test
Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue.

Locations

Country	Name	City	State
India	Ramaiah Medical College	Bengaluru
United Kingdom	University of Derby	Derby	Derbyshire
United Kingdom	Northumbria University	Newcastle Upon Tyne
United Kingdom	Sheffield Hallam University	Sheffield	South Yorkshire
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
Sheffield Hallam University	King's College London, MS Ramaiah Medical College & Hospitals, Northumbria University, University of Derby, University of Illinois at Chicago, University of Nottingham

Countries where clinical trial is conducted

United States,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom Profile Questionnaire	Description of previous and current symptom/s of Long COVID	Baseline
Other	Quality of Life questionnaire	EQ-5D-5L	Baseline
Other	Sleep Behavour	Pittsburgh Sleep Quality Index	Baseline
Other	Fatigue Questionnaire- FAS	Fatigue Assessment Scale	Baseline, Day 1 and Day 2
Other	Fatigue Questionnaire- MFI	Multidimensional Fatigue Index (MFI-20)	Baseline, Day 1 and Day 2
Other	Medical Research Council Dyspnoea Scale	Breathlessness scale	Baseline
Other	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
Other	Cognition	Montreal cognitive assessment	Baseline
Other	6 minute walk	6 minute walk distance (metres)	Baseline
Other	Timed Up and Go	5m timed up and go (seconds)	Baseline
Other	Lung Function Assessment- FEV1	Forced Expiratory Volume in 1 Second (l)	Baseline
Other	Lung Function Assessment- FVC	Forced Vital Capacity (l)	Baseline
Other	Lung Function Assessment- PEF	Peak Expiratory Flow Rate (l/min)	Baseline
Other	Lung Function Assessment- MIP	Maximal Inspiratory Pressure (mmHg)	Baseline
Other	Lung Function Assessment- MEP	Maximal Expiratory Pressure (mmHg)	Baseline
Other	Height	measurement of body stature (m)	Baseline
Other	Weight	Measurement of body mass (kg)	Baseline
Other	body mass index	weight and height will be combined to report BMI in kg/m^2	Baseline
Primary	Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation	Rate of Oxygen Utilisation (VO2; l/min)	During CPET1 and CPET2
Primary	Cardiopulmonary Exercise Test- Rate of carbon dioxide production	Rate of Carbon Dioxide Production (VCO2; l/min)	During CPET1 and CPET2
Primary	Cardiopulmonary Exercise Test- Respiratory Exchange Ratio	Respiratory Exchange Ratio (VO2/VCO2)	During CPET1 and CPET2
Primary	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
Primary	Cardiopulmonary Exercise Test- Respiratory Threshold	Respiratory Threshold breath by breath (l/min)	During CPET1 and CPET2
Primary	Cardiopulmonary Exercise Test- Minute Ventilation	Minute Ventilation using breath by breath (l/min)	During CPET1 and CPET2
Primary	Cardiopulmonary Exercise Test- Blood lactate	Blood Lactate Concentration from fingertip (mmol/l)	During CPET1 and CPET2
Primary	Prevalence of symptoms of post exertional Malaise	Symptom Profile post exercise protocols- Questionnaire	7 days post exercise
Secondary	Blood biomarkers of Inflammation- IL-6	Concentration of Interleukin 6	Day 1 and Day 2
Secondary	Blood biomarkers of Inflammation- IL-1	Concentration of Interleukin 1	Day 1 and Day 2
Secondary	Blood biomarkers of Inflammation- Microclots	Number of Microclots	Day 1 and Day 2
Secondary	Blood biomarkers of Inflammation- D-Dimer	D-Dimer Concentration	Day 1 and Day 2
Secondary	Blood biomarkers of Inflammation- CRP	C-Reactive protein Concentration	Day 1 and Day 2
Secondary	Echocardiogram	12 lead echocardiogram.	Baseline, Day 1 and Day 2
Secondary	Resting Systolic Blood Pressure	Systolic Blood Pressure at Rest (mmHg)	Baseline, Day 1 and Day 2
Secondary	Resting Diastolic Blood Pressure	Diastolic Blood Pressure at Rest (mmHg)	Baseline, Day 1 and Day 2
Secondary	Exercise Diastolic Blood Pressure	Diastolic Blood Pressure During Exercise (mmHg)	Baseline, Day 1 and Day 2
Secondary	Exercise Systolic Blood Pressure	Systolic Blood Pressure During Exercise (mmHg)	Baseline, Day 1 and Day 2