Cardiopulmonary Exercise Tests in Patients With Long COVID

NCT06394921 | Completed

• 1 other identifier: PREPP19
• Study Type: observational
• Target: 146
• Locations: 3 countries
• Sites: 5

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.

Conditions

Long COVID; COVID Long-Haul

Outcome Measures

Primary Outcomes (8)

• 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

  Symptom Profile post exercise protocols- Questionnaire

  7 days post exercise

Secondary Outcomes (10)

• Blood biomarkers of Inflammation- IL-6

  Day 1 and Day 2

• Blood biomarkers of Inflammation- IL-1

  Day 1 and Day 2

• Blood biomarkers of Inflammation- Microclots

  Day 1 and Day 2

• Blood biomarkers of Inflammation- D-Dimer

  Day 1 and Day 2

• Blood biomarkers of Inflammation- CRP

  Day 1 and Day 2

Other Outcomes (18)

• Symptom Profile Questionnaire

  Baseline

• Quality of Life questionnaire

  Baseline

• Sleep Behavour

  Baseline

Study Arms (1)

People with Long COVID

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.

Procedure: 2 day cardiopulmonary exercise test

Interventions

2 day cardiopulmonary exercise test PROCEDURE

Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue.

People with Long COVID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Sheffield Hallam University: lead
• MS Ramaiah Medical College & Hospitals: collaborator
• University of Illinois at Chicago: collaborator
• University of Nottingham: collaborator
• Northumbria University: collaborator
• King's College London: collaborator
• University of Derby: collaborator

Study Sites (5)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

Ramaiah Medical College

Bengaluru, India

Location

University of Derby

Derby, Derbyshire, United Kingdom

Location

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Location

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma samples

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: May 1, 2024
• Study Start: March 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (3); IN (1)