Symptom Assessment, General Symptoms, Statistics on Sequelae and Disability
Conditions
Interventions
In the intervention group, 50 participants will be evaluated and will undergo a screening stage, to define the volunteer's aptitude according to the inclusion/exclusion criteria established in the stu
EADS-21 Psychometric Scale to assess Stress, Anxiety and Depression indices
12-Item Short-Form Health Survey (SF-12) to assess quality of life
Visual Analog Scale (VAS) to assess pain status
Modified Fatigue Impact Scale (MFIS) to assess fatigue status
and the Cognitive Failure Questionnaire (CFQ) to assess the cognitive status of the participants, and in cases of pulmonary sequelae, the participants will be referred for a CT scan before and after t
55021
27463
28397
Sponsors
Universidade Federal do Amapá
Universidade Federal do Amapá
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult volunteers, over 18; of both genders; with previous clinical and laboratory diagnosis of Covid-19; with or without comorbidities; presenting complaints of persistent symptoms of Covid-19 for at least 14 days after recovery from acute Covid-19; with or without pulmonary sequelae by Covid-19 upon presentation of Computed Tomography.
Exclusion criteria
Exclusion criteria: Volunteer children or teenagers, under 18 years old; without previous clinical and laboratory diagnosis of Covid-19; presenting limiting conditions of attendance or use of a pacemaker; report of untrustworthy symptoms to the clinical picture of post-Covid sequelae or reports longer than the 12 weeks period after recovery from the acute phase of Covid-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved quality of life: The 12-Item Short-Form Health Survey (SF-12) was created as an alternative to the 36-Item Health Survey (SF-36) instrument, allowing for a quick assessment of quality of life through twelve items derived from the SF-36, distributed in a graduated Likert-type scale, which assess 8 domains through 2 components: Physical Component - Physical Component Summary or PCS (assess functional capacity, limitation by physical aspect, pain and general health status) and the Mental Component - Mental Component Summary or MCS (evaluate vitality, social aspects, emotional aspects and mental health). Both in the SF-12 and in the SF-36, the score varies on a scale from zero to one hundred, with the highest scores being associated with better levels of Quality of Life. Fatigue Reduction: The Modified Fatigue Impact Scale (MFIS) is a Likert-type scale, consisting of 21 questions with scores from 0 to 4 points per item, which allows the assessment of 3 domains of the Fatigue State: Physical Domain (items 4,6,7,10,13,14,17,20 and 21); Cognitive Domain (items 1,2,3,5,11,12,15,16,18 and 19); and Psychosocial Domain (items 8 and 9). The total MFIS score is given by the sum of the three domains and ranges from 0 to 84 points. Cognitive Improvement: The Cognitive Failures Questionnaire (CFQ) is a Likert-type scale, consisting of 25 questions with scores ranging from 0 (Never) to 4 points (Very often), allowing the assessment of 3 domains: Memory (items 2, 6, 12, 16, 17, 20, 22 and 23), Attention (items 1, 3, 4, 7, 8, 9, 13, 14, 18, 19 and 21) and Action ( Items 5, 10, 11, 15, 24 and 25). The total CFQ score ranges from 0 (zero) to 100 (one hundred), with the highest scores being associated with worse cognitive declines. Reduction of symptoms associated with Post-Covid Syndrome: The questionnaire developed by the International Severe Acute Respiratory Emerging and Emerging Infection Consortium (ISARIC) allows the collection of data on health status, lifestyle, clinica | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in breathing pattern: the Pulmonary Function tests, consisting of Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC), assessed by Spirometry, being repeated 3 times before and after the intervention, the values ??being considered normal above 80% of FVC, and FEV1 will have as reference the age and height of the participants, and in both, the difference cannot exceed 10% between repetitions. In the Respiratory Muscle Strength Test, the parameters of Maximum Inspiratory Pressure (PImax) and Maximum Expiratory Pressure (PEmax) will be evaluated. To compare the collected variables, Student's t test will be applied, with Simple Linear Regression and a significance level of 5% (p<0.05). Changes in pulmonary tomographic pattern: will be measured by subjective descriptive analysis of Computed Tomography by a Radiologist Physician unrelated to the study before and after the intervention, identifying changes in the tomographic pattern, and comparing the data obtained from the assessment of Pulmonary Function and Muscle Strength Test Respiratory.; Improvement in Stress, Anxiety and Depression indices: The triad Stress, Anxiety and Depression will be assessed using the EADS-21 psychometric test, which allows measuring the mental health status of the participants, with items 3, 5, 10, 13, 16, 17 and 21 to assess depression; items 2, 4, 7, 9, 15, 19 and 20 for anxiety assessment; and items 1, 6, 8, 11, 12, 14 and 18 to assess stress. At the end of the test, the scores allow distinguishing in 5 different degrees the mental health status, for 1) depression, 2) anxiety and 3) stress respectively: Normal: 0–9 / 0–7 / 0–14; Light: 10–13 / 8–9 / 15–18; Moderate: 14–20 / 10–14 / 19–25; Fort 21–27 / 15–19 / 26–33; and Extremely Severe: 28+ / 20+ / 34+. Data will be stored and treated by descriptive statistics. Improvement in Pain perception: Pain will be assessed by adapting the Visual Analog Scale (VAS), numbered from 0 to 4, where 0 corresponds to | — |
Countries
Brazil
Contacts
Public ContactErick Neri
Outcome results
None listed