Covid19TROPICNCT05027724
Technology Assisted Solutions for the Recognition of Objective Physiological Indicators of Post-Coronavirus-19 Fatigue
An observational study of Covid19 and Post Viral Fatigue, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19, Post Viral Fatigue
- How many people
- 108 participants
- Where
- 1 siteIreland
- Study dates
- 17 May 2021to 5 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background: At the time of writing, over 214 million people globally are infected with the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that up to 50% of people are experiencing debilitating levels of fatigue months after recovering from the acute phase of COVID-19, known as post COVID-19 Chronic Fatigue Syndrome (CFS). The most challenging aspect in the management of CFS for clinicians is the lack of objective measurement tools. At present, most clinical and research measurements of fatigue have relied upon self-reported perceptions of sensations such as exhaustion or weariness. We believe that an objective, technology-based assessment of this complex condition is required for the quantification of complex multi-system dynamic physiological signals in order to guide clinicians in directing targeted valuable resources towards therapeutic interventions with specificity and rigour to those patients who are most in need.
Aim: The aim of the TROPIC study is to identify bio- signals and contributing factors in the development of post-Covid-19 Chronic Fatigue Syndrome using a suite of technology-assisted assessment techniques.
TROPIC STUDY PARTICULARS:
The primary endpoint will be successful recruitment and completion of data collection of 100 participants in the TROPIC cohort.
Setting: Assessments will take place in the Falls and Syncope Unit and Clinical Research Facility of St James's Hospital.
Participants: Participants will be recruited from five sources; (i) the Robert Mayne Day Hospital, (ii) the Falls and Syncope Unit, (iii) Advocacy Groups, (iv) staff who contracted COVID-19, and (v) the Post COVID-19 outpatient (OPD) Clinic.
Participants must be aged 18 years or older, have a history of COVID-19 and be free of exclusion criteria outlined in later sections.
Data collection and analysis: Participants will be invited for one assessment session to St James's Hospital (SJH), where they will undergo a series of neurocardiovascular, neurocognitive and physical performance tests, outlined in more detail in later sections.
- Conditions
- Covid19, Post Viral Fatigue
- Keywords
- fatigue, deconditioning, orthostatic intolerance, long-COVID
- Medical subject headings
- COVID-19, Fatigue, Orthostatic Intolerance, Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Stand with Near Infrared Spectroscopy and Electromyography
10 minute supine rest, followed by a three minute stand
Measured: Day 0
Drug Free Passive Head Up Tilt Test
10 minute supine rest, followed by a 10 minute 70 degree passive tilt.
Measured: 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
Measured: 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
Measured: Day 0
Neurocognitive assessments
Deary-Liewald Task
Measured: Day 0
Strength assessments: leg press and dynamometry
5 times sit-to-stand hand dynamometry based grip strength assessment
Measured: Day 0
Secondary outcomes (3)
Fatigue
Chalder Fatigue Scale (11-item scale with a 0-3 Likert scale for each item. Scores range from 0 - 33. A higher score represents more severe fatigue)
Measured: Day 0
Depression
Center for Epidemiological Studies-Depression Scale (20-item measure with a 0-3 Likert scale response for each item. Scores range from 0-60. A higher score represents more severe depressive symptoms)
Measured: Day 0
Post-Traumatic Stress (after contracting COVID-19)
Impact of Events Scale (Revised) (22-item questionnaire with a 0-5 Likert scale for each response. Scores range from 0 - 110. A higher score indicates an increased perception of stress after an event).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start17 May 2021
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Science Foundation Ireland
- Responsible party
- Principal investigator, Román Romero Ortuño, University of Dublin, Trinity College
- Investigators
- Roman Romero-Orthuno, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027724
- Sponsor's protocol ID
- 20/COV/8493
- Acronym
- TROPIC
- Status last verified
- May 2022
- First submitted
- 23 Aug 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35566502Monaghan 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.
PubMed 35309052
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Solutions for the Recognition of Objective Physiological Indicators of Post-Coronavirus-19 Fatigue
- ClinicalTrials.gov ID
- NCT05027724
- Acronym / sponsor ID
- TROPIC / 20/COV/8493
- Conditions
- Covid19, Post Viral Fatigue
- Keywords
- fatigue, deconditioning, orthostatic intolerance, long-COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Science Foundation Ireland
- Study start
- 17 May 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: At the time of writing, over 214 million people globally are infected with the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that up to 50% of people are experiencing debilitating levels of fatigue months after recovering from the acute phase of COVID-19, known as post COVID-19 Chronic Fatigue Syndrome (CFS). The most challenging aspect in the management of CFS for clinicians is the lack of objective measurement tools. At present, most clinical and research measurements of fatigue have relied upon self-reported perceptions of sensations such as exhaustion or weariness. We believe that an objective, technology-based assessment of this complex condition is required for the quantification of complex multi-system dynamic physiological signals in order to guide clinicians in directing targeted valuable resources towards therapeutic interventions with specificity and rigour to those patients who are most in need.
Aim: The aim of the TROPIC study is to identify bio- signals and contributing factors in the development of post-Covid-19 Chronic Fatigue Syndrome using a suite of technology-assisted assessment techniques.
TROPIC STUDY PARTICULARS:
The primary endpoint will be successful recruitment and completion of data collection of 100 participants in the TROPIC cohort.
Setting: Assessments will take place in the Falls and Syncope Unit and Clinical Research Facility of St James's Hospital.
Participants: Participants will be recruited from five sources; (i) the Robert Mayne Day Hospital, (ii) the Falls and Syncope Unit, (iii) Advocacy Groups, (iv) staff who contracted COVID-19, and (v) the Post COVID-19 outpatient (OPD) Clinic.
Participants must be aged 18 years or older, have a history of COVID-19 and be free of exclusion criteria outlined in later sections.
Data collection and analysis: Participants will be invited for one assessment session to St James's Hospital (SJH), where they will undergo a series of neurocardiovascular, neurocognitive and physical performance tests, outlined in more detail in later sections.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Active Stand with Near Infrared Spectroscopy and Electromyography
Time frame: Day 0
10 minute supine rest, followed by a three minute stand
Drug Free Passive Head Up Tilt Test
Time frame: Day 0
10 minute supine rest, followed by a 10 minute 70 degree passive tilt.
Cardiorespiratory fitness test
Time frame: Day 0
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
Gait assessment via Gaitrite™ system
Time frame: Day 0
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
Neurocognitive assessments
Time frame: Day 0
Deary-Liewald Task
Strength assessments: leg press and dynamometry
Time frame: Day 0
5 times sit-to-stand hand dynamometry based grip strength assessment
3 secondary outcomes
Fatigue
Time frame: Day 0
Depression
Time frame: Day 0
Post-Traumatic Stress (after contracting COVID-19)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 35566502Romero-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.
- Derived from this study: PubMed 35309052Monaghan 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.
- Individual participant dataSharing planned: No
Related trials for Covid19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Romero-Orthuno, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Post Viral Fatigue, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Stand with Near Infrared Spectroscopy and Electromyography (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.