RecruitingRecruiting
Prevalence of Long COVID-19 in the Canary Islands
NCT05228691 · University of Las Palmas de Gran Canaria
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Long COVID: Evaluation of Physical and Functional Status
About this study
It is intended to develop a Cross-sectional Descriptive Observational Study. The investigation will be carried out following the guidelines of "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE).
A registry will be carried out at a multicenter level, in which a physical-functional evaluation will be carried out. of the patient who has suffered from COVID-19 and whose signs and symptoms last 12 weeks after its detection. This assessment is carried out by physiotherapists members of the entire Canarian Autonomous Community. Some quizzes will be completed with the assistance of a specific evaluator (physiotherapist), while that others will be self-completion.
In order to avoid bias and try to guarantee the highest methodological quality, prior to the recruitment, screening and evaluation of the participants, a specific training for all evaluators (physiotherapists). They will be addressed general theoretical content on COVID-persistent, justification and development logistics of the proposed study protocol, and implementation of the battery of evaluation tests.
The study participants will be recruited through non-recruited sampling probabilistic convenience.
The statistical analysis of the data will be carried out using the statistical software International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) 27.
Categorical variables will be summarized using percentages and relative frequencies. The equality of proportions of the categories will be contrasted with the non-parametric tests Bi-nominal and Chi-Square (Goodness of fit). To test the possible association between categorical variables will use the Chi-square test or the exact test Fisher's.
To analyze the possible association between ordinal categorical variables, we will use to contrast Spearman's correlation coefficient. Numeric variables are summarized with the mean and standard deviation or by means of the median and the interquartile range, depending on whether or not the normality condition of the data is met.
To analyze the normality of the samples, the test of Kolmogorov-Smirnov or Shapiro-Wild. To compare the means of two independent samples, will use the Student's T test or the non-parametric U-Mann Whitney test, depending on whether or not the data normality condition.
In the case of means of 3 or more independent samples, will use the one-way ANOVA procedure or the non-parametric Kruskal Wallis test, depending on whether or not the normality condition of the data is met. To analyze the possible association between the numerical variables, the contrast of the coefficient of linear Pearson correlation.
According to the objectives and the associations that could be detected, it will be possible to use other statistical tools, or propose the construction of mathematical models predictive. The results will be considered statistically significant if p-value \<0.05.
Eligibility criteria
Inclusion Criteria:
* Have been positive for COVID-19 since the declaration of the state of alarm throughout the Spanish territory to deal with the health emergency situation caused by COVID-19 (March 14, 2020).
* Symptoms associated with COVID-19 at least after 12 weeks of its detection.
* Adequate cognitive and physical level to understand and perform the tests evaluation.
Exclusion Criteria:
* Present comorbidities prior to suffering from COVID-19 whose symptoms are resemble Post-acute COVID-19.
* Fibromyalgia.
* Chronic fatigue.
* Neuromuscular disease.
* Not having signed the informed consent.
* Person undergoing treatment for active cancer.
Study design
Enrollment target: 600 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-03-22
Estimated completion: 2026-05-01
Last updated: 2025-08-28
Interventions
Other: Evaluation and Education
Primary outcomes
- • Post-COVID-19 Functional Status scale (5 days before start the intervention)
- • Short Physical Performance Battery (Baseline at 0 minutes)
- • Aerobic capacity (Baseline at 0 minutes)
Sponsor
University of Las Palmas de Gran Canaria · other
Contacts & investigators
ContactAníbal Báez Suárez, PhD · contact · anibal.baez@ulpgc.es · +34652077692
InvestigatorAníbal Báez Suárez, PhD · principal_investigator, University of Las Palmas de Gran Canaria
All locations (1)
University of Las Palmas de Gran CanariaRecruiting
Las Palmas de Gran Canaria, Las Palmas, Spain