Profile of COVID-19 Patients Related to Fatigue

Sponsor
Universidad de Granada (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05731817
Collaborator
(none)
398
10.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
398 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Profile of COVID-19 Patients Related to Fatigue
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
COVID-19 patients

COVID-19 patients

Other: Observational study
N/A - observational study.

Outcome Measures

Primary Outcome Measures

  1. Perceived Fatigue [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.

  2. Multidimensional Fatigue [Through study completion, an average of 1 year]

    To assess multidimensional fatigue using the multidimensional fatigue inventory

  3. Fatigue Severity [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

  4. Fatigue Impact [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.

  5. Muscular Fatigue [Through study completion, an average of 1 year]

    To assess muscular fatigue using surface electromyography

Secondary Outcome Measures

  1. COVID-19 information [Through study completion, an average of 1 year]

    To assess information about the date and symptoms when COVID-19 was diagnosed

  2. Dyspnea [Through study completion, an average of 1 year]

    To assess Dyspnea perception using the borg modified scale

  3. Cough [Through study completion, an average of 1 year]

    To assess cough using the leicester cough questionnaire

  4. Pain intensity [Through study completion, an average of 1 year]

    To assess pain intensity using the visual analogue scale and brief pain inventory

  5. Functional status [Through study completion, an average of 1 year]

    To assess functional status using the post-covid functional scale and functional independence measure

  6. Frailty [Through study completion, an average of 1 year]

    To assess frailty using the clinical frailty scale

  7. Health-related Quality of life [Through study completion, an average of 1 year]

    To assess health-related quality of life using the euroqol-5d

  8. Psychological status [Through study completion, an average of 1 year]

    To assess Psychological status using the hospital anxiety and depression scale

  9. Sleep quality [Through study completion, an average of 1 year]

    To assess sleep quality using the Pittsburgh Sleep Quality Index

  10. Nutritional status [Through study completion, an average of 1 year]

    To assess nutritional status using the mini nutritional assessment

  11. Physical activity [Through study completion, an average of 1 year]

    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.

  12. Kinesiophobia [Through study completion, an average of 1 year]

    To assess kinesiophobia using the TAMPA scale

  13. Exercise capacity [Through study completion, an average of 1 year]

    To assess exercise capacity using the Short Physical Performance Battery and the 6 minutes walk test

  14. Strength [Through study completion, an average of 1 year]

    To assess strength using dynamometry

  15. Heart rate variability [Through study completion, an average of 1 year]

    To assess heart rate variability using holter

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad de Granada

Investigators

  • Principal Investigator: Irene Torres Sánchez, PhD, Universidad de Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Irene Torres Sánchez, PT, PhD, Principal investigator, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT05731817
Other Study ID Numbers:
  • COVIDATE-01
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Irene Torres Sánchez, PT, PhD, Principal investigator, Universidad de Granada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2023