Cardiopulmonary Exercise Tests in Patients With Long COVID

NCT ID: NCT06394921

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Long COVID COVID Long-Haul

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

2 day cardiopulmonary exercise test

Intervention Type PROCEDURE

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

Interventions

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2 day cardiopulmonary exercise test

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MS Ramaiah Medical College & Hospitals

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

University of Derby

OTHER

Sponsor Role collaborator

Sheffield Hallam University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Ramaiah Medical College

Bengaluru, , India

Site Status

University of Derby

Derby, Derbyshire, United Kingdom

Site Status

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Site Status

Northumbria University

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States India United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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PREPP19

Identifier Type: -

Identifier Source: org_study_id

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