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NCT Number: NCT05731817

Profile of COVID-19 Patients Related to Fatigue

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

N/A - observational study.

Primary outcomes

  1. 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.

  2. Multidimensional Fatigue

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

    To assess multidimensional fatigue using the multidimensional fatigue inventory

  3. 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

  4. 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.

  5. Muscular Fatigue

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

    To assess muscular fatigue using surface electromyography

Secondary outcomes

  1. COVID-19 information

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

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

  2. Dyspnea

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

    To assess Dyspnea perception using the borg modified scale

  3. Cough

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

    To assess cough using the leicester cough questionnaire

  4. Pain intensity

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

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

  5. Functional status

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

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

  6. Frailty

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

    To assess frailty using the clinical frailty scale

  7. Health-related Quality of life

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

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

  8. Psychological status

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

    To assess Psychological status using the hospital anxiety and depression scale

  9. Sleep quality

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

    To assess sleep quality using the Pittsburgh Sleep Quality Index

  10. Nutritional status

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

    To assess nutritional status using the mini nutritional assessment

  11. Physical activity

    Time frame: 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

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

    To assess kinesiophobia using the TAMPA scale

  13. Exercise capacity

    Time frame: 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

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

    To assess strength using dynamometry

  15. Heart rate variability

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

    To assess heart rate variability using holter

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Feb 16, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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