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<p>The Physical and Rehabilitation Medicine Institute of the University of Sao Paulo Medical School General Hospital (IMREA-HCFMUSP) conducts a research project to investigate the mid- and long-term functioning and disabling health conditions of people with clinical and serological diagnosis of COVID-19.</p>
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<p><strong>Title:</strong> Mid- and long-term complications affecting functioning after COVID-19<br><strong>Principal investigator:</strong> Linamara Rizzo Battistella<br><strong>Institution:</strong> University of Sao Paulo Medical School General Hospital<br><strong>CAAE:</strong> 39744120.3.0000.0068<br><strong>IRB approval register:</strong> 4.391.560</p>
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<h2 class="wp-block-heading title-4">Abbreviated Research Protocol</h2>
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<p><strong>Objectives</strong></p>
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<p>Identifying, in the mid- and long-term, the functioning aspects related to cognitive, mobility and language impairments and the chronic needs of patients with a clinical and serological diagnosis of COVID-19.</p>
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<p><strong>Methods</strong></p>
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<p>The study includes adult patients, 18 years or older, who were treated at the University of Sao Paulo Medical School General Hospital (HCFMUSP) for more than 24 hours, admitted to either ward-based or intensive care, with a confirmed diagnosis of COVID-19. 1,200 patients will be invited to participate based on their consecutive recruitment.</p>
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<p><strong>Study design</strong></p>
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<p>This is a prospective observational study, with face-to-face assessments conducted between 6 and 8 and again between 12 and 14 months after hospital discharge from HCFMUSP. Data will be collected using REDCap, an internet application to control and access electronic questionnaires and databases.</p>
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<p><strong>Assessments</strong></p>
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<p>It includes the demographic and clinical data collected from each participant during the treatment of acute infection, including age, sex, ethnicity, education, previous comorbidities and symptoms, as well as the use of selected medications. In addition, it registers the time since onset of symptoms, the length of hospital stay and in intensive care, if any.</p>
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<h3 class="wp-block-heading title-4">Sociodemographic variables and clinical characteristics:</h3>
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<ol class="wp-block-list"><!-- wp:list-item -->
<li>Age</li>
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<li>Sex</li>
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<li>Ethnicity</li>
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<li>Education</li>
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<li>Profession / Occupation / Employment</li>
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<li>Income</li>
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<li>Comorbidities: hypertension, diabetes, obesity, cardiovascular condition, malignant neoplasm, chronic kidney disease, chronic liver disease, asthma, stroke, spinal cord injury, neurological diseases (Parkinson's disease, Epilepsy, Dementia), immunodeficiency, anxiety, depression, other psychiatric health conditions, swallowing disorders, other (specify)</li>
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<li>Impairments: Motor, vision, nerve, pain, musculoskeletal injury</li>
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<li>Time since symptoms onset</li>
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<li>Length of stay</li>
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<h3 class="wp-block-heading title-4">Investigated symptoms:</h3>
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<li>Fever or chills</li>
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<li>Headache</li>
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<li>Abnormal changes in body temperature</li>
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<li>Unexplainable sweating or facial flushing</li>
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<li>Difficulties in vision (for example, double or blurred)</li>
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<li>Hearing difficulties</li>
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<li>Tinnitus</li>
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<li>Loss of smell</li>
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<li>Loss of taste</li>
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<li>Difficulty swallowing</li>
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<li>Cough</li>
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<li>Sore throat</li>
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<li>Shortness of breath</li>
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<li>Breathing faster than normal</li>
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<li>Fatigue or tiredness</li>
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<li>Chest pain or discomfort</li>
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<li>Palpitations</li>
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<li>Dizziness</li>
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<li>Fainting</li>
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<li>Diarrhea</li>
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<li>Nausea</li>
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<li>Vomiting</li>
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<li>Indigestion or gastroesophageal reflux</li>
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<li>Loss of appetite or unexplained weight loss</li>
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<li>Constipation</li>
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<li>Abdominal pain</li>
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<li>Difficulty concentrating or reading</li>
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<li>Mental confusion</li>
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<li>Disorientation</li>
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<li>Memory problems or forgetfulness</li>
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<li>Muscle weakness</li>
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<li>Muscle pain or cramps</li>
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<li>Joint pain or edema</li>
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<li>Tingling or numbness in the face or mouth</li>
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<li>Tingling, numbness, burning, shocks, pinches sensation</li>
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<li>Edema</li>
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<li>Urinary incontinence or difficulty passing urine</li>
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<li>Unexplained menstrual irregularity</li>
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<li>Sexual dysfunction or loss of libido</li>
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<li>Unexplained hair loss</li>
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<li>Skin lesions</li>
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<li>Difficulty sleeping</li>
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<li>Changes in mood, irritability, depression</li>
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<li>Overreactions to alcohol consumption</li>
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<li>Others</li>
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<li>No symptoms since hospital discharge</li>
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<h3 class="wp-block-heading title-4">Description of functional assessments scales and tools:</h3>
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<figure class="wp-block-table is-style-regular"><table><tbody><tr><td><strong>Scales / Tools</strong></td><td><strong>Short description</strong></td></tr><tr><td>Epworth Sleepiness Scale<sup>&nbsp;(1,2)</sup></td><td>Measurement of the subject’s general level of daytime sleepiness. The EES is based on questions referring to eight situations, based on how likely they would fall asleep. The higher the score, the more chance of falling asleep.<br><br>Situations evaluated: Sitting and reading; watching TV; sitting, inactive in a public place (e.g., a theatre or a meeting); as a passenger in a car for an hour without a break; lying down to rest in the afternoon when circumstances permit; sitting and talking to someone; sitting quietly after a lunch without alcohol; and, in a car, while stopped for a few minutes in the traffic.<br><br>Response levels for each situation: 0 (never); 1 (slight); 2 (moderate); and 3 (high).</td></tr><tr><td>EuroQoL-5 Dimensions-5 Levels&nbsp;<sup>(3)</sup></td><td>It assesses quality of life in five dimensions. Each dimension has five response levels (from “no problems” to “unable” to carry out activities related to each domain).<br><br>Dimensions: Mobility; self-care; usual activities; pain/discomfort; anxiety/depression.<br><br>Response levels for each dimension: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (unable to/extreme problems).</td></tr><tr><td>Functional Assessment of Chronic Illness Therapy - Fatigue&nbsp;<sup>(4-6)</sup></td><td>Measure of fatigue consisting of 13-items, which are scored from 0 to 4. All scores are summed, and reversed if necessary, to a single score ranging from 0 to 52. Higher score represents better quality of life or less fatigue.<br><br>Items: I feel fatigued; I feel weak all over; I feel listless (“washed out”); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; I am frustrated by being too tired to do the things I want to do; I have to limit my social activity because I am tired.<br><br>Response levels for each item: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much).</td></tr><tr><td>Functional Independence Measure&nbsp;<sup>(7)</sup></td><td>It assesses the dependence levels for performing motor and cognitive activities. It ranges from 1 to 7 points, complete dependence to complete independence.<br><br>Domains: self-care; transfer; mobility; sphincter control; communication; and cognition, including memory, social interaction and problem solving.<br><br>Rating options: 1 (total assistance); 2 (maximal assistance); 3 (moderate assistance); 4 (minimal assistance); 5 (supervision/setup); 6 (modified independence); and 7 (complete independence).</td></tr><tr><td>Functional Oral Intake Scale&nbsp;<sup>(8)</sup></td><td>A 7-point ordinal scale which focuses on what the patient consumes orally on a daily basis. Levels 1 through 3 relate to varying degrees of non-oral feeding. Levels 4 through 7 relate to degrees of feeding without non-oral supplementations.<br><br>Classifications options: 1 (nothing by mouth); 2 (tube dependent with minimal attempts of food or liquid); 3 (tube dependent with consistent oral intake of food or liquid); 4 (total oral diet of a single consistency); 5 (total oral diet with multiple consistencies but requiring special preparation or compensations); 6 (total oral diet with multiple consistencies without special preparation, but with specific food limitations); and 7 (total oral diet with no restrictions).</td></tr><tr><td>Hand Grip Strength Measurement&nbsp;<sup>(9)</sup></td><td>Hand Grip strength measured by dynamometry is well established as an indicator of muscle status, particularly among older adults. The grip strength of older adults can be interpreted using age and sex stratified norms or T-scores from younger adults.<br><br>Hand Grip strength was measured with a Jamar ® hydraulic hand dynamometer (Sammons Preston, Bolingbrook, Illinois, USA) with patients seated their elbows by their sides and flexed to right angles and a neutral wrist position. Three measurements were performed for both sides, and the mean score was recorded.</td></tr><tr><td>Insomnia Severity Index&nbsp;<sup>(10)</sup></td><td>It consists of a 7-item self-report questionnaire, to evaluate the nighttime and daytime components of insomnia. It evaluates severity of problems regarding sleep onset, sleep maintenance and early morning awakening as well as sleep dissatisfaction, interference with daytime functioning, if others note those problems, and if all of this causes distress. It is a rated with a 5-point Likert scale rendering a score range from zero to 28. The higher the score, the more severe the situation</td></tr><tr><td>Modified Borg Dyspnea Scale<sup>&nbsp;(11-13)</sup></td><td>The Modified Borg Dyspnea Scale or Borg Category-Ratio 10 is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise.<br><br>Scoring levels: 0 (nothing at all); 0.5 (very, very slight); 1 (very slight); 2 (slight); 3 (moderate); 4 (somewhat severe); 5 (severe); 6; 7 (very severe); 8; 9 (very, very severe); and 10 (maximal).</td></tr><tr><td>Modified Medical Research Council Dyspnea Scale&nbsp;<sup>(14)</sup>&nbsp;</td><td>Five-point scale based on degrees of physical activities that cause breathlessness and it is used for the clinical measurement of dyspnea.<br><br>Answer options: “Not troubled with breathlessness except with strenuous exercise”; “Troubled by shortness of breath when hurrying on the level or walking up a slight hill”; “Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level”; “Stops for breath after walking about 100 yards or after a few minutes on the level”; “Too breathless to leave the house or breathless when dressing or undressing”.</td></tr><tr><td>Post-COVID-19 Functional Status scale&nbsp;<sup>(15)</sup></td><td>An ordinal tool proposed to measure the full spectrum of functional outcomes following COVID-19. This scale can be used for tracking functional status over time as well as for research purposes.<br><br>Question: How much are you currently affected in your everyday life by COVID-19?<br><br>Answer options: “I have no limitations in my everyday life and no symptoms, pain, depression or anxiety related to the infection”; “I have negligible limitations in my everyday life as I can perform all usual duties/ activities, although I still have persistent symptoms, pain, depression or anxiety”; “I suffer from limitations in my everyday life as I occasionally need to avoid or reduce usual duties/activities or need to spread these over time due to symptoms, pain, depression or anxiety. I am, however, able to perform all activities without any assistance”; “I suffer from limitations in my everyday life as I am not able to perform all usual duties/activities due to symptoms, pain, depression or anxiety. I am, however, able to take care of myself without any assistance”; “I suffer from severe limitations in my everyday life: I am not able to take care of myself and therefore I am dependent on nursing care and/or assistance from another person due to symptoms, pain, depression or anxiety”.</td></tr><tr><td>Timed Up and Go&nbsp;<sup>(16)</sup></td><td>Measures the time in seconds taken by the participant to stand up from a chair, walk 3 meters, turn, walk back to the chair and sit without physical assistance, however with normally used walking aid.&nbsp;</td></tr><tr><td>Pain Visual Analogue Scale&nbsp;<sup>(17)</sup></td><td>100 mm line with verbal descriptors “no pain” and “worst imaginable pain” at every end. It is used to ask the patient to indicate its pain intensity for the right and the left side of the body. The highest of both sides was included into data analysis.</td></tr><tr><td>01-minute Sit to Stand Test&nbsp;<sup>(18)</sup></td><td>The 1-MSTST or the 60 seconds sit to stand test (STS-60) is performed with an armless chair and consists of doing as much sit to stand movements possible in 1 minute. When completed, it registers how many repetitions performed. It also registers oxygen saturation and dyspnea level (using the Modified Borg Dyspnea Scale) before and after the test.</td></tr><tr><td>10-meter Walking Test&nbsp;<sup>(19)</sup></td><td>The time required to walk 10 meters was measured by use of the time reported by G-walk. Subjects walk in a straight line. Test performed with a static start and stop. The distance of ten meter is divided by the time in seconds to calculate gait speed.</td></tr><tr><td>Medical Research Council Sum Score&nbsp;<sup>(20)</sup></td><td>Evaluates strength in muscle groups of all four limbs. A score between 0 and 5 is assigned to each of them. Scores ranges from 0 to 60 and a value below 48 correlates with muscle weakness. This is considered severe if it is lower than 36.<br><br>Movements assessed: abduction of the arm; flexion of the forearm; extension of the wrist; flexion of the hip; extension of the knee; and dorsal flexion of the foot.<br><br>Scoring options: 0 (no visible/palpable contraction); 1 (visible/palpable contraction without movement of the limb); 2 (movement of the limb, but not against gravity); 3 (movement against gravity); 4 (movement against gravity and some resistance); 5 (normal).</td></tr><tr><td>Muscle Thickness and Echogenicity&nbsp;<sup>(21)</sup></td><td>The thickness and echogenicity of the rectus femoris (RF) and vastus intermedius (VI) of the right quadriceps femoris muscle are evaluated, using two portable ultrasound systems: GE Healthcare LOGIQe (Wuxi, China) and FujiFilm SonoSite M-Turbo (Bothell, Washington, USA), both with a 13 MHz linear transducer. Measurements are performed with the patient in the supine position, with the knee extended and relaxed.<br><br>It measures the distal third of the distance between the lower border of the anterior-superior iliac spine and the upper pole of the patella. A sagittal image is registered for evaluation of echogenicity followed by a transversal image with minimal pressure to avoid muscle compression for measurement of muscle thickness and echogenicity.</td></tr><tr><td>World Health Organization Disability Assessment Schedule 2.0- 12-item version&nbsp;<sup>(22,23)</sup></td><td>It captures the level of functioning in six domains of life. In each of the 12 items, individuals have to estimate the magnitude of the difficulty during the previous 30 days using a five-point scale for each domain. Higher scores of the simple sum of domain scores reflects greater disability. Score ranges from 12 to 60.<br><br>Domains: cognition; mobility; self-care; getting along; life activities; and participation.<br><br>Answer options: 1 (none); 2 (mild); 3 (moderate); 4 (severe); and 5 (extreme or cannot do).</td></tr></tbody></table></figure>
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<h3 class="wp-block-heading title-4">Statistical analyses</h3>
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<p>The collected data will first be stratified by type of impairment, thus forming groups of patients by health condition. The clinical, demographic and functional data for the entire sample and for each group of health conditions will be described by mean and standard deviation in addition to frequencies, if they are continuous or categorical, respectively. After this description, the clinical, demographic and functional data of each group will be tested for normality by Shapiro-Wilk test.</p>
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<p>Therefore, statistical tests of association between dependent variables (presence of impairment) and independent variables (clinical data, demographic and functional data) will be applied to the data in order to identify the described, and possibly latent, variables that may be related (correlation tests and regression tests) to the incidence of impairments after infection by SARS-CoV-2 (COVID-19).</p>
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<p>Statistical analyzes will be performed using the Stata 14® statistical package or the R software, and statistical significance will be established whenever p≤0.05.</p>
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<h3 class="wp-block-heading title-4">References</h3>
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<p>1. Johns MW. A new method for measuring daytime sleepiness: The Epworth sleepiness scale. Sleep 1991; 14: 540–5.</p>
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<p>2. Talk About Sleep, Inc. The Epworth Sleepiness Scale. Natl. Assoc. State EMS Off. https://nasemso.org/wp-content/uploads/neuro-epworthsleepscale.pdf (accessed April 10, 2021).</p>
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<p>3. EuroQol Research Foundation. EQ-5D-5L User Guide. 2019&nbsp;<a href="https://euroqol.org/publications/user-guides/">https://euroqol.org/publications/user-guides/</a>.</p>
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<p>4. Acaster S, Dickerhoof R, DeBusk K, Bernard K, Strauss W, Allen LF. Qualitative and quantitative validation of the FACIT-fatigue scale in iron deficiency anemia. Health Qual Life Outcomes 2015; 13. DOI: 10.1186/s12955-015-0257-x.</p>
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<p>5. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 2003; 1: 1–7.</p>
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<p>6. FACIT-group. Functional Assessment of Chronic Illness Therapy – Fatigue Scale. FACIT-Fatigue. https://www.facit.org/measures/FACIT-Fatigue (accessed April 8, 2021).</p>
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<p>7. Linacre JM, Heinemann AW, Wright BD, Granger CV, Hamilton BB. The structure and stability of the functional independence measure. Arch Phys Med Rehabil 1994; 75: 127–32.</p>
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<p>8. Crary MA, Carnaby Mann GD, Groher ME. Initial Psychometric Assessment of a Functional Oral Intake Scale for Dysphagia in Stroke Patients. Arch Phys Med Rehabil 2005; 86: 1516–20.</p>
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<p>9. Bohannon RW. Muscle strength: Clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care 2015; 18: 465–70.</p>
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<p>10. Morin CM, Belleville G, Bélanger L, Ivers H. The insomnia severity index: Psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011; 34: 601–8.</p>
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<p>11. Borg, Gunnar A.V. Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982; 14: 377–81.</p>
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<p>12. Williams N. The Borg Rating of Perceived Exertion (RPE) scale. Occup Med 2017; 67: 404–5.</p>
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<p>13. Banerjee D, Kamuren J, Baird GL, et al. The Modified Borg Dyspnea Scale does not predict hospitalization in pulmonary arterial hypertension. Pulm Circ 2017; 7: 384–90.</p>
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<p>14. Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest 1988; 93: 580–6.</p>
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<p>15. Klok FA, Boon GJAM, Barco S, et al. The post-COVID-19 functional status scale: A tool to measure functional status over time after COVID-19. Eur Respir J 2020; 56: 10–2.</p>
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<p>16. Podsiadlo D, Richardson S. The Timed “Up &amp; Go”: A Test of Basic Functional Mobility for Frail Elderly Persons. J Am Geriatr Soc 1991; 39: 142–8.</p>
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<p>17. Williamson A, Hoggart B. Pain: A review of three commonly used pain rating scales. J Clin Nurs 2005; 14: 798–804.</p>
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<p>18. Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test - Systematic review of procedures, performance, and clinimetric properties. J Cardiopulm Rehabil Prev 2019; 39: 2–8.</p>
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<p>19. Scivoletto G, Tamburella F, Laurenza L, Foti C, Ditunno JF, Molinari M. Validity and reliability of the 10-m walk test and the 6-min walk test in spinal cord injury patients. Spinal Cord 2011; 49: 736–40.</p>
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<p>20. Hermans G, Clerckx B, Vanhullebusch T, et al. Interobserver agreement of medical research council sum score and handgrip strength in the intensive care unit. Muscle Nerve 2012; 45: 18–25.</p>
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<p>21. Vieira L, Rocha LPB, Mathur S, et al. Reliability of skeletal muscle ultrasound in critically ill trauma patients. Rev Bras Ter Intensiva 2019; 31: 464–73.</p>
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<p>22. Üstun T, Kostanjsek N, Chatterji S, Rehm J. Measuring Health and Disability. 2010 DOI: 10.1017/cbo9780511759055.008.</p>
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<p>23. Luciano JV, Ayuso-Mateos J, Aguado J, et al. The 12-item World Health Organization Disability Assessment Schedule II (WHO-DAS II): a nonparametric item response analysis. 2010</p>
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