NCT06394921Completed
Cardiopulmonary Exercise Tests in Patients With Long COVID
Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study
Source: ClinicalTrials.gov · Last updated 22 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 146 (actual)
- First submitted
- 26 Mar 2024
- Start date
- 1 Mar 2023
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Sheffield Hallam University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06394921
What you commit to
- Study type: Observational
- Participants enrolled: 146
- From 1 Mar 2023 to the primary completion date, 30 Apr 2024
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • \<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).
Who the study is looking for
- • 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Derby Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Northumbria University Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Sheffield Hallam University Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Ramaiah Medical College Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.