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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05027724
Other study ID # 20/COV/8493
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 17, 2021
Est. completion date November 5, 2021

Study information

Verified date May 2022
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Ireland St James's Hospital Dublin 8 Co. Dublin

Sponsors (2)

Lead Sponsor Collaborator
University of Dublin, Trinity College Science Foundation Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Active Stand with Near Infrared Spectroscopy and Electromyography 10 minute supine rest, followed by a three minute stand Day 0
Primary Drug Free Passive Head Up Tilt Test 10 minute supine rest, followed by a 10 minute 70 degree passive tilt. Day 0
Primary 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
Primary 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
Primary Neurocognitive assessments Deary-Liewald Task Day 0
Primary Strength assessments: leg press and dynamometry 5 times sit-to-stand hand dynamometry based grip strength assessment Day 0
Secondary 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) Day 0
Secondary 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) Day 0
Secondary 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). Day 0
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