Profile of COVID-19 Patients Related to Fatigue

COVID-19 Clinical Trial

Official title:

Profile of COVID-19 Patients Related to Fatigue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731817
• Other study ID #: COVIDATE-01
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Universidad de Granada
• Contact: Irene Torres Sánchez, PhD
• Phone: 0034958249591
• Email: irenetorres[@]ugr.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue

Intervention

Other:
• Observational study
N/A - observational study.

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Fatigue	To assess perceived fatigue using the borg modified scale. Scale ranges from 0 to 10, with higher punctuation indicating higher fatigue perception.	Through study completion, an average of 1 year
Primary	Multidimensional Fatigue	To assess multidimensional fatigue using the multidimensional fatigue inventory	Through study completion, an average of 1 year
Primary	Fatigue Severity	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	Through study completion, an average of 1 year
Primary	Fatigue Impact	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.	Through study completion, an average of 1 year
Primary	Muscular Fatigue	To assess muscular fatigue using surface electromyography	Through study completion, an average of 1 year
Secondary	COVID-19 information	To assess information about the date and symptoms when COVID-19 was diagnosed	Through study completion, an average of 1 year
Secondary	Dyspnea	To assess Dyspnea perception using the borg modified scale	Through study completion, an average of 1 year
Secondary	Cough	To assess cough using the leicester cough questionnaire	Through study completion, an average of 1 year
Secondary	Pain intensity	To assess pain intensity using the visual analogue scale and brief pain inventory	Through study completion, an average of 1 year
Secondary	Functional status	To assess functional status using the post-covid functional scale and functional independence measure	Through study completion, an average of 1 year
Secondary	Frailty	To assess frailty using the clinical frailty scale	Through study completion, an average of 1 year
Secondary	Health-related Quality of life	To assess health-related quality of life using the euroqol-5d	Through study completion, an average of 1 year
Secondary	Psychological status	To assess Psychological status using the hospital anxiety and depression scale	Through study completion, an average of 1 year
Secondary	Sleep quality	To assess sleep quality using the Pittsburgh Sleep Quality Index	Through study completion, an average of 1 year
Secondary	Nutritional status	To assess nutritional status using the mini nutritional assessment	Through study completion, an average of 1 year
Secondary	Physical activity	To assess physical activity using the international physical activity questionnaire. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in Metabolic Equivalent (MET)-min/week and time spent sitting.	Through study completion, an average of 1 year
Secondary	Kinesiophobia	To assess kinesiophobia using the TAMPA scale	Through study completion, an average of 1 year
Secondary	Exercise capacity	To assess exercise capacity using the Short Physical Performance Battery and the 6 minutes walk test	Through study completion, an average of 1 year
Secondary	Strength	To assess strength using dynamometry	Through study completion, an average of 1 year
Secondary	Heart rate variability	To assess heart rate variability using holter	Through study completion, an average of 1 year