Cognitive, Psychological, and Physical Functioning in Long-COVID Patients With Different Levels of Fatigue.

Recruiting

• Conditions: Post-Acute COVID-19 Syndrome

• Registration Number: NCT05758558
• Lead Sponsor: Hasselt University

Brief Summary

Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment issues. This clinical heterogeneity complicates the identification of the appropriate needs and care.

The aim of this cross-sectional study is to identify subgroups (clusters) of post COVID patients based on clinical symptoms, demographic characteristics, levels of fatigue and physical, cognitive and psychological functioning of the individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-07
• Study Start: 2023-05-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

The participant must report current persisting symptoms (such as brain fog, anxiety, shortness of breath, headaches but also others) and indicate on the Post COVID-19 Functional Status Scale that these have an impact on everyday functioning (grade 2, 3, and 4). These symptoms need to be present for more than two months.

Further inclusion criteria are:

• Fatigue Severity Scale (FSS) score > 4
• Aged over 18 years old
• Willing to sign the digital informed consent
• Dutch speaking and Dutch understanding
• Be tested positive for COVID-19, i.e. by reverse transcription polymerase chain reaction (RT-PCR), computed tomography (CT) of the lungs, or symptom-based diagnosis by the general practitioner.

Exclusion Criteria

• Pregnant women
• Pacemaker, defibrillator
• Brain or nerve disorders
• Epilepsy
• A copper spiral or recent bone fracture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue severity	Day 1	Fatigue severity scale (FSS)
Psychological evaluation	Day 1	Anxiety and depression Scale (HADS); MINI-S, MINI International Neuropsychiatric Interview - Simplified (Overbeek \& Schruers 2019)
Physical evaluation	Day 1	Hand grip strength (Jamar hand dynamometer) \& Six Minute Walk Test (6MWT)
Cognitive evaluation	Day 1	Multi-modal Evaluation of Sensory Sensitivity (MESSY); Montreal Cognitive Assessment (MoCA)

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Diepenbeek, Belgium