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OpenTrials
Completed

NCT Number: NCT05758558

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

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.

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Key information

Conditions

Post-Acute COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasselt University

Diepenbeek, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Physical evaluation

    Time frame: Day 1

    Hand grip strength (Jamar hand dynamometer) & Six Minute Walk Test (6MWT)

  2. Fatigue severity

    Time frame: Day 1

    Fatigue severity scale (FSS)

  3. Psychological evaluation

    Time frame: Day 1

    Anxiety and depression Scale (HADS); MINI-S, MINI International Neuropsychiatric Interview - Simplified (Overbeek & Schruers 2019)

  4. Cognitive evaluation

    Time frame: Day 1

    Multi-modal Evaluation of Sensory Sensitivity (MESSY); Montreal Cognitive Assessment (MoCA)

Other outcomes

  1. Number of clusters

    Time frame: Day 1

    The main outcome of the study is identification of the best-fitting number of clusters and the reliability of clustering. To check for differences in characteristics between the clusters, we will use an analysis of variance for normally distributed continuous variables and the nonparametric Kruskal-Wallis test for nonnormally variances (R package "FSA").

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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