Technology Assisted Solutions for the Recognition of Objective Physiological Indicators of Post-Coronavirus-19 Fatigue

NCT05027724 | Completed

• 1 other identifier: 20/COV/8493
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Preliminary research from our group indicates that up to half of COVID-19 patients are experiencing symptoms consistent with severe fatigue a median of 10 weeks after their initial illness, while almost one third of those previously employed have not returned to work. At present, most clinical and research measurements of fatigue have relied upon self-reported perception of sensations such as exhaustion or weariness. Using such tools, there is an inherent challenge for clinicians in differentiating between patients who are experiencing fatigue at a psychosocial level, versus those who are actively physiologically and neurocognitively deconditioned. The TROPIC study will use our existing clinical expertise and technology assisted solutions to address features of post-COVID-19 fatigue by quantifying physiological signatures of adverse sequelae in adult patients previously diagnosed with COVID-19, who are now COVID-19 negative. Our suite of assessments will encompass four systems; physical deconditioning, orthostatic instability, neurocognitive deficits and respiratory sequelae. This will not only inform accurate objective diagnostics of post-COVID-19 Chronic Fatigue Syndrome, but will also guide clinicians in directing the most appropriate therapeutic interventions with maximum efficacy and specificity, bringing not only patient-related but also health system and economic benefits.

Conditions

Covid19; Post Viral Fatigue

Keywords

fatigue; deconditioning; orthostatic intolerance; long-COVID

Outcome Measures

Primary Outcomes (6)

• Active Stand with Near Infrared Spectroscopy and Electromyography

  10 minute supine rest, followed by a three minute stand

  Day 0

• Drug Free Passive Head Up Tilt Test

  10 minute supine rest, followed by a 10 minute 70 degree passive tilt.

  Day 0

• Cardiorespiratory fitness test

  Submaximal (Test terminated at 85% maximal heart rate) cycle ergometer based assessment, using indirect calorimetry and heart rate monitoring to determine breath-by-breath oxygen consumption

  Day 0

• Gait assessment via Gaitrite™ system

  Three walks on a sensor-embedded 9m floor mat. Walk 1 - normal gait Walk 2 - normal gait with dual cognitive task Walk 3 - fast walk

  Day 0

• Neurocognitive assessments

  Deary-Liewald Task

  Day 0

• Strength assessments: leg press and dynamometry

  5 times sit-to-stand hand dynamometry based grip strength assessment

  Day 0

Secondary Outcomes (3)

• Fatigue

  Day 0

• Depression

  Day 0

• Post-Traumatic Stress (after contracting COVID-19)

  Day 0

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants over 18 years, with a history of COVID-19 who are community ambulant, mobilizing independently and free from contra-indications to testing procedures.

You may qualify if:

• Participants age 18 years or over.
• Able to give informed consent
• Good spoken and written English
• History of COVID-19 and experiencing prolonged symptoms.
• Community ambulant
• Able to mobilise independently (with or without aid).
• Able to transfer with minimal assistance of one person from lying to standing.
• Patients with a history of COVID-19 who now present with a negative swab

You may not qualify if:

• Unwilling to participate
• Aged less than 18
• Persons with cognitive impairment / dementia that would render them unable to give informed consent.
• Persons who are pregnant
• Persons who require more than min assistance of one person to transfer from lying to standing.
• Persons who are not independently mobile.
• Persons with an acute illness.
• Participants with skin allergies to adhesive tapes.
• Participants with upper limb lymphoedema (cuff-site)
• Participants registered as blind or partially blind.
• Persons for whom tilt testing and exercise testing is contra-indicated as per results of the Physical Activity Readiness Questionnaire or anyone falling under the absolute contra-indications to exercise testing as per the American Heart Association's Guidelines for Exercise testing, including: 1. Acute myocardial infarction within 2 days (or any other acute cardiac event) 2. Unstable angina 3. Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise 4. Uncontrolled symptomatic heart failure 5. Symptomatic sever aortic stenosis 6. Suspected or known dissecting aneurysm 7. Acute myocarditis or pericarditis 8. Acute pulmonary embolus or pulmonary infarction 9. Acute systemic infection, accompanied by fever, body aches or swollen lymph glands, 10. patients in whom low organ perfusion pressures may compromise end artery supplied tissue, 11 severe left ventricular outflow obstruction, 12. critical mitral stenosis.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Science Foundation Ireland: collaborator

Study Sites (1)

St James's Hospital

Dublin, Co. Dublin, D08 NHY1, Ireland

Location

Related Publications (2)

• Romero-Ortuno R, Jennings G, Xue F, Duggan E, Gormley J, Monaghan A. Predictors of Submaximal Exercise Test Attainment in Adults Reporting Long COVID Symptoms. J Clin Med. 2022 Apr 23;11(9):2376. doi: 10.3390/jcm11092376.

  PMID: 35566502 DERIVED

• Monaghan A, Jennings G, Xue F, Byrne L, Duggan E, Romero-Ortuno R. Orthostatic Intolerance in Adults Reporting Long COVID Symptoms Was Not Associated With Postural Orthostatic Tachycardia Syndrome. Front Physiol. 2022 Mar 4;13:833650. doi: 10.3389/fphys.2022.833650. eCollection 2022.

  PMID: 35309052 DERIVED

MeSH Terms

Conditions

COVID-19; Fatigue; Orthostatic Intolerance; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Roman Romero-Orthuno, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Discipline of Medical Gerontology, Trinity College Dublin

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 30, 2021
• Study Start: May 17, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)