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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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).

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

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

Recruiting Locations

More Details

NCT ID
NCT06394921
Status
Completed
Sponsor
Sheffield Hallam University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.