In progress: Technology Assisted Solutions for the Recognition of Objective Physiological Indicators of Post-Coronavirus-19 Fatigue (TROPIC), 2021 -

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.

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) Participants from earlier post COVID-19 Fatigue research in SJH who have consented to be contacted for further studies, (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.

https://clinicaltrials.gov/ct2/show/NCT05027724

 

Primary Outcome Measures :

1. Active Stand with Near Infrared Spectroscopy and Electromyography [ Time Frame: Day 0 ]
   10 minute supine rest, followed by a three minute stand
   
   
2. Drug Free Passive Head Up Tilt Test [ Time Frame: Day 0 ]
   10 minute supine rest, followed by a 10 minute 70 degree passive tilt.
   
   
3. 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
   
   
4. 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
   
   
5. Neurocognitive assessments [ Time Frame: Day 0 ]
   Choice reaction time test Sustained attention to response task
   
   
6. Strength assessments: leg press and dynamometry [ Time Frame: Day 0 ]
   5 times sit-to-stand hand dynamometry based grip strength assessment

(*) https://www.gaitrite.com/

Thoughts? @Snow Leopard @Jonathan Edwards

 

The first two could be interesting, but the rest suggest they don't quite understand how to measure fatigue. If they used a 2 day provocation-test strategy, then it might be more useful, but...

 

Which would be a pity, as the need for objective measures in this field is rarely acknowledged and this seems to be done by a highly respected PI, and at a first glance I thought it's a good start and it could be worthwhile to reach out to the researchers to make them aware that if they wanted to get useful data they should think about amending the outcome measures a bit.

Couldn't also measures 4-6 deliver useful data on fatigability if done with prior exertion, cognitive or physical?

It's not even clear that they are aware that there are diverse diagnostic criteria for ME/CFS when they state that....

It seems they use the term for any kind of severe fatigue that's present after an unspecified number of months after a COVID infection?

Which again would be a pity.

That doesn't give me hope that they have a good understanding of their research subject either ("fatigue at a psychosocial level" vs being "physiologoligically and neurocognitively deconditioned" as the only two options.


Do people thinkt it could be worthwhile ro reach out to the resarchers to ask which criteria they use for diagnosing people with "post COVID-19 Chronic Fatigue Syndrome (CFS)" and if necessary, give them a few links to the most relevant literature?

And also suggest amendments of the outcome measures?

 

Sponsors and Collaborators:

University of Dublin, Trinity College

Science Foundation Ireland (SFI)


About the PI:

Román Romero Ortuño
https://www.tcd.ie/medicine/staff/romeroor/

His research contributions in the area of frailty have been recognised with the 2015 British Geriatrics Society Rising Star Award, the 2017 Count of Cartagena Award from the Royal National Academy of Medicine of Spain and the 2018 President of Ireland Future Research Leaders Award.

 

This is not encouraging. I have no idea what "fatigue at a psychosocial level" is even supposed to mean when it's basically the nonsense that's been applied to us and so obviously doesn't mean a damn thing. I also have no idea why they decide to frame this as being physiologically deconditioned, it's been obvious for a long time that it can switch on and off and so obviously has nothing to do with "deconditioning", even less so with neural wiring or whatever is fashionable these days.

Honestly it's the obsession with fatigue that makes any progress impossible. It's the wrong word, we feel sick, and having to use a less accurate word because of historical and ideological reasons is as foolish as having invented such flimsy wishy-washy nonsense as "fatigue at a psychosocial level".

The intent seems good, but the execution misguided because they can't be bothered to learn beyond the superficial nonsense that's been around for decades. I expect nothing useful out of this, they clearly did not involve patients at any point in the process. And of course being seemingly unaware or indifferent to PEM, well, pffft.

 

I agree with the objective "Technology Assisted Solutions for the Recognition of Objective Physiological Indicators of Post-Coronavirus-19 Fatigue". I've no idea if the indicators they are suggesting [EDIT - are objective].