Clinical trial NCT05731817: Profile of COVID-19 Patients Related to Fatigue
Official title: Profile of COVID-19 Patients Related to Fatigue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
fatigue
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients

Brief summary: More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.

The objective of this study is to evaluate the profile of surviving patients of COVID-19 in relation to fatigue.

Detailed description: Background: More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.

Objectives: Evaluate the profile of surviving patients of COVID-19 in relation to fatigue;

Methodology: Observational study. The profile of the survivors of COVID-19 will be described, dividing them into 2 groups based on the presence or absence of fatigue.

Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.

The evaluation will be carried out through Google forms, telematic means or face-to-face depending on the variables.

A symptomatic evaluation of fatigue, aspects related to fatigue and physical performance will be carried out.

Eligibility criteria: Inclusion Criteria:

* diagnosis of COVID-19
* adults (\>18 years)
* basic knowledge and access to the internet
* wish to participate in the study and sign the informed consent

Exclusion Criteria:

* patients with severe comorbidities that interfere with the ability to perform the study, and those with mental, physical or organic problems that under medical criteria may pose a risk to the patient

Primary outcomes:
measure: Perceived Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Multidimensional Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Fatigue Severity
timeFrame: Through study completion, an average of 1 year
measure: Fatigue Impact
timeFrame: Through study completion, an average of 1 year
measure: Muscular Fatigue
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: COVID-19 information
timeFrame: Through study completion, an average of 1 year
measure: Dyspnea
timeFrame: Through study completion, an average of 1 year
measure: Cough
timeFrame: Through study completion, an average of 1 year
measure: Pain intensity
timeFrame: Through study completion, an average of 1 year
measure: Functional status
timeFrame: Through study completion, an average of 1 year
measure: Frailty
timeFrame: Through study completion, an average of 1 year
measure: Health-related Quality of life
timeFrame: Through study completion, an average of 1 year
measure: Psychological status
timeFrame: Through study completion, an average of 1 year
measure: Sleep quality
timeFrame: Through study completion, an average of 1 year
measure: Nutritional status
timeFrame: Through study completion, an average of 1 year
measure: Physical activity
timeFrame: Through study completion, an average of 1 year
measure: Kinesiophobia
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity
timeFrame: Through study completion, an average of 1 year
measure: Strength
timeFrame: Through study completion, an average of 1 year
measure: Heart rate variability
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Irene Torres Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: