Clinical trial NCT05228691: Prevalence of Long COVID-19 in the Canary Islands
Official title: Long COVID: Evaluation of Physical and Functional Status
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: physical therapy modality
Long COVID
post-acute COVID-19 syndrome
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the Autonomous Community of the Canary Islands presenting signs and symptoms related to COVID-19 and that last beyond 12 weeks from when disease debuted.

Brief summary: With more than 246 million people diagnosed with coronavirus 2019 (COVID-19) around the world, many of whom have required medical attention for past 23 months, greater emphasis is being placed on post-acute care of COVID-19 survivors. According to recent data, millions of patients who have recovered from acute COVID-19 are experiencing persistent symptoms, which lead to disability and impaired activities of daily living.

Various terms have been used to describe the condition of patients who do not return to their initial health status to include post-acute sequelae of COVID-19, such as post-acute COVID syndrome (PACS) and Long COVID.

The growing global burden of COVID-19 suggests that the potential effects of Long COVID in public health are vast even if Long COVID is experienced by a small proportion of patients recovering from acute infection.

The ability to identify patients at high risk for Long COVID and forecasting medical resource requirements is of important clinical utility in the present.

In view of the large number of people surviving after infection with COVID-19 and that should require follow-up, determine which patients are at risk of have Long COVID and who require close monitoring is crucial. In this study, therefore, we set out to analyze what type of patient profile with COVID-19 who, after 12 weeks of having suffered the infection, experiences the signs and symptoms described by current literature.

Detailed description: 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.

Primary outcomes:
measure: Post-COVID-19 Functional Status scale
timeFrame: 5 days before start the intervention
measure: Short Physical Performance Battery
timeFrame: Baseline at 0 minutes
measure: Aerobic capacity
timeFrame: Baseline at 0 minutes
measure: Muscle Strength
timeFrame: Baseline at 0 minutes
Secondary outcomes:
measure: Musculoskeletal pain
timeFrame: 5 days before start the intervention
measure: Dyspnea
timeFrame: 5 days before start the intervention
measure: Fatigue
timeFrame: 5 days before start the intervention
measure: Physical activity
timeFrame: 5 days before start the intervention
measure: Subjective health status assessment
timeFrame: 5 days before start the intervention
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: University of Las Palmas de Gran Canaria
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
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