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Clinical Trials/NCT05731817
NCT05731817Active, not recruitingNot Applicable

Profile of COVID-19 Patients Related to Fatigue

Universidad de Granada1 site in 1 country398 target enrollmentStarted: February 15, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
398
Locations
1
Primary Endpoint
Fatigue Impact

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

COVID-19 patients

COVID-19 patients

Intervention: Observational study (Other)

Outcomes

Primary Outcomes

Fatigue Impact

Time Frame: Through study completion, an average of 1 year

To assess fatigue impact using the modified fatigue impact scale. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. This scale can range from 0 to 36.

Perceived Fatigue

Time Frame: Through study completion, an average of 1 year

To assess perceived fatigue using the borg modified scale. Scale ranges from 0 to 10, with higher punctuation indicating higher fatigue perception.

Multidimensional Fatigue

Time Frame: Through study completion, an average of 1 year

To assess multidimensional fatigue using the multidimensional fatigue inventory

Fatigue Severity

Time Frame: Through study completion, an average of 1 year

To assess fatigue severity using the fatigue severity scale. The total score ranges from 7 to 63 points, with higher punctuation indicating higher fatigue severity

Muscular Fatigue

Time Frame: Through study completion, an average of 1 year

To assess muscular fatigue using surface electromyography

Secondary Outcomes

  • Kinesiophobia(Through study completion, an average of 1 year)
  • Dyspnea(Through study completion, an average of 1 year)
  • COVID-19 information(Through study completion, an average of 1 year)
  • Frailty(Through study completion, an average of 1 year)
  • Physical activity(Through study completion, an average of 1 year)
  • Heart rate variability(Through study completion, an average of 1 year)
  • Functional status(Through study completion, an average of 1 year)
  • Cough(Through study completion, an average of 1 year)
  • Sleep quality(Through study completion, an average of 1 year)
  • Nutritional status(Through study completion, an average of 1 year)
  • Pain intensity(Through study completion, an average of 1 year)
  • Psychological status(Through study completion, an average of 1 year)
  • Exercise capacity(Through study completion, an average of 1 year)
  • Health-related Quality of life(Through study completion, an average of 1 year)
  • Strength(Through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Irene Torres Sánchez

PT, PhD, Principal investigator

Universidad de Granada

Study Sites (1)

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