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

NCT05758558 | Completed

• 1 other identifier: CME2022/021 S66200
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (4)

• Physical evaluation

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

  Day 1

• Fatigue severity

  Fatigue severity scale (FSS)

  Day 1

• Psychological evaluation

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

  Day 1

• Cognitive evaluation

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

  Day 1

Other Outcomes (1)

• Number of clusters

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants that match the criteria of the recently published definition of the post-COVID-19 condition will be considered eligible to participate in the study.\[8\] Post-COVID-19 has been defined as a condition that occurs in individuals with a history of confirmed SARS-CoV-2 infection, and that occurs usually within three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis. Consequently, participants that either have or have not been hospitalized will both be allowed to participate in this study. COVID infection will be self-reported by the participant. Participants will be encouraged to show any test certificate but they are not obligated to do so.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Assistant

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 7, 2023
• Study Start: May 5, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

BE (1)