Long COVID: Evaluation of Physical and Functional Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Short Physical Performance Battery
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Fibromyalgia.
- •Chronic fatigue.
- •Neuromuscular disease.
- •Not having signed the informed consent.
- •Person undergoing treatment for active cancer.
Outcomes
Primary Outcomes
Short Physical Performance Battery
Time Frame: Baseline at 0 minutes
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.
Aerobic capacity
Time Frame: Baseline at 0 minutes
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).
Post-COVID-19 Functional Status scale
Time Frame: 5 days before start the intervention
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.
Muscle Strength
Time Frame: Baseline at 0 minutes
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.
Secondary Outcomes
- Musculoskeletal pain(5 days before start the intervention)
- Dyspnea(5 days before start the intervention)
- Physical activity(5 days before start the intervention)
- Fatigue(5 days before start the intervention)
- Subjective health status assessment(5 days before start the intervention)
Investigators
Aníbal Báez Suárez
Principal Investigator
University of Las Palmas de Gran Canaria