- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Granada
-
Granada, Granada, Spain
- University of Granada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COVID-19 patients
|
N/A - observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 1 year
|
|
Multidimensional Fatigue
Time Frame: Through study completion, an average of 1 year
|
To assess multidimensional fatigue using the multidimensional fatigue inventory
|
Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
|
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.
|
Through study completion, an average of 1 year
|
|
Muscular Fatigue
Time Frame: Through study completion, an average of 1 year
|
To assess muscular fatigue using surface electromyography
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through study completion, an average of 1 year
|
|
Dyspnea
Time Frame: Through study completion, an average of 1 year
|
To assess Dyspnea perception using the borg modified scale
|
Through study completion, an average of 1 year
|
|
Cough
Time Frame: Through study completion, an average of 1 year
|
To assess cough using the leicester cough questionnaire
|
Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
|
Frailty
Time Frame: Through study completion, an average of 1 year
|
To assess frailty using the clinical frailty scale
|
Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
|
Psychological status
Time Frame: Through study completion, an average of 1 year
|
To assess Psychological status using the hospital anxiety and depression scale
|
Through study completion, an average of 1 year
|
|
Sleep quality
Time Frame: Through study completion, an average of 1 year
|
To assess sleep quality using the Pittsburgh Sleep Quality Index
|
Through study completion, an average of 1 year
|
|
Nutritional status
Time Frame: Through study completion, an average of 1 year
|
To assess nutritional status using the mini nutritional assessment
|
Through study completion, an average of 1 year
|
|
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.
|
Through study completion, an average of 1 year
|
|
Kinesiophobia
Time Frame: Through study completion, an average of 1 year
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To assess kinesiophobia using the TAMPA scale
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Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
|
Strength
Time Frame: Through study completion, an average of 1 year
|
To assess strength using dynamometry
|
Through study completion, an average of 1 year
|
|
Heart rate variability
Time Frame: Through study completion, an average of 1 year
|
To assess heart rate variability using holter
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene Torres Sánchez, PhD, Universidad de Granada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- COVID-19
- Fatigue
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- COVIDATE-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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