Clinical trial NCT06394921: Cardiopulmonary Exercise Tests in Patients With Long COVID
Official title: Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long COVID
COVID Long-Haul
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: MS Ramaiah Medical College & Hospitals
name: University of Illinois at Chicago
name: University of Nottingham
name: Northumbria University
name: King's College London
name: University of Derby
First posted: 2024-05-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test- Rate of carbon dioxide production
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test- Respiratory Exchange Ratio
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test- Respiratory Threshold
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test- Minute Ventilation
timeFrame: During CPET1 and CPET2
measure: Cardiopulmonary Exercise Test- Blood lactate
timeFrame: During CPET1 and CPET2
measure: Prevalence of symptoms of post exertional Malaise
timeFrame: 7 days post exercise
Secondary outcomes:
measure: Blood biomarkers of Inflammation- IL-6
timeFrame: Day 1 and Day 2
measure: Blood biomarkers of Inflammation- IL-1
timeFrame: Day 1 and Day 2
measure: Blood biomarkers of Inflammation- Microclots
timeFrame: Day 1 and Day 2
measure: Blood biomarkers of Inflammation- D-Dimer
timeFrame: Day 1 and Day 2
measure: Blood biomarkers of Inflammation- CRP
timeFrame: Day 1 and Day 2
measure: Echocardiogram
timeFrame: Baseline, Day 1 and Day 2
measure: Resting Systolic Blood Pressure
timeFrame: Baseline, Day 1 and Day 2
measure: Resting Diastolic Blood Pressure
timeFrame: Baseline, Day 1 and Day 2
measure: Exercise Diastolic Blood Pressure
timeFrame: Baseline, Day 1 and Day 2
measure: Exercise Systolic Blood Pressure
timeFrame: Baseline, Day 1 and Day 2
Other outcomes:
measure: Symptom Profile Questionnaire
timeFrame: Baseline
measure: Quality of Life questionnaire
timeFrame: Baseline
measure: Sleep Behavour
timeFrame: Baseline
measure: Fatigue Questionnaire- FAS
timeFrame: Baseline, Day 1 and Day 2
measure: Fatigue Questionnaire- MFI
timeFrame: Baseline, Day 1 and Day 2
measure: Medical Research Council Dyspnoea Scale
timeFrame: Baseline
measure: Post COVID-19 functional status Scale
timeFrame: Baseline
measure: Cognition
timeFrame: Baseline
measure: 6 minute walk
timeFrame: Baseline
measure: Timed Up and Go
timeFrame: Baseline
measure: Lung Function Assessment- FEV1
timeFrame: Baseline
measure: Lung Function Assessment- FVC
timeFrame: Baseline
measure: Lung Function Assessment- PEF
timeFrame: Baseline
measure: Lung Function Assessment- MIP
timeFrame: Baseline
measure: Lung Function Assessment- MEP
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: body mass index
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Bengaluru
country: India
facility: Ramaiah Medical College
city: Derby
country: United Kingdom
facility: University of Derby
state: Derbyshire
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: South Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
References: