Prevalence of Long COVID-19 in the Canary Islands
ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Las Palmas de Gran Canaria
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Present comorbidities prior to suffering from COVID-19 whose symptoms are resemble Post-acute COVID-19.
Fibromyalgia.
Chronic fatigue.
Neuromuscular disease.
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Evaluation and Education
Other interventionA functional physical evaluation will be carried out and they will be informed about the characteristics of their symptoms. After the evaluation, they will be taught a guideline of exercises and recommendations.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Long COVID1 intervention
Trial outcomes
Primary outcomes
1
Post-COVID-19 Functional Status scale
The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death, D), and covers the full range of functional outcomes by focusing on limitations in usual tasks/activities, whether at home or at work/study, as well as lifestyle changes. The scale ratings are intuitive and can be easily understood by clinicians and patients alike.
Time frame
5 days before start the intervention2
Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) is a measure of physical performance that has been used to predict long-term disability and/or future institutionalization in adults aged 65 years and older. The test consists of three specific physical performance activities, scored from 0 to 4, with a summed score of 12. Higher scores reflect higher levels of function.
Time frame
Baseline at 0 minutes3
Aerobic capacity
Aerobic capacity will be measured with the 1 minute sit to stand test: The purpose of the test is to assess the exercise capacity and leg muscle strength. The movement required is to get up from this chair with the legs straight and sit back continuing the repetitions as fast as possible within one minute. The mean number of 1-minute sit to stand test repetitions reported in the literature achieved ranged from 8.1 (patients with stroke) to 50.0 (young men).
Time frame
Baseline at 0 minutes4
Muscle Strength
Muscle Strength will be measured with Medical Research Council (MRC) Scale : is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). This score was defined as the sum of the MRC scores of six muscles in the upper and lower limbs on both sides, so the score ranged from 60 (normal) to 0 (quadriplegic). The Criteria require that each of the six muscle groups be tested bilaterally, each scoring from 0 to 5.
Time frame
Baseline at 0 minutesSecondary outcomes
1
Musculoskeletal pain
Orebro Musculoskeletal Pain Questionnaire (OMPQ) This questionnaire is a clinical tool used to identify patients at risk of develop long-term chronic musculoskeletal problems. The questionnaire includes 21 questions, which are scored on a scale of 0 to 10, with a maximum possible score of 210 points.
Time frame
5 days before start the intervention2
Dyspnea
The Modified Medical Research Council (mMRC) Dyspnea Scale will be used. It´s a five-level rating scale based on the patient's perception of dyspnoea in daily activities. Grade 0: breathless with strenuous exercise; Grade 1: short of breath when hurrying on level ground or walking up a slight hill; Grade 2: walked slower than people of the same age on level ground, and experienced breathlessness or the need to stop to breathe when walking on level ground at their own pace; Grade 3: stop to breathe after walking about 100 yards, or after a few minutes on level ground; and Grade 4: too breathless to leave the house, or breathless when dressing or undressing.
Time frame
5 days before start the intervention3
Fatigue
The Fatigue Assessment Scale (FAS) is a tool that provides information about the physical and psychological aspects of fatigue, and provides a single overall score measuring its intensity. A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63
Time frame
5 days before start the intervention4
Physical activity
The International Physical Activity Questionnaires (IPAQ). 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 of Task (MET)-min/week and time spent sitting. A 7 items questionnaire, with open-ended questions surrounding individuals' last 7-day recall of physical activity.
Time frame
5 days before start the interventionSponsors and contacts
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Source ClinicalTrials.gov