Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Respiratory muscle strength |
The assessment of respiratory muscle strength will be performed by measuring the maximum respiratory pressures (Maximum Inspiratory Pressure: PImax and Maximum Expiratory Pressure: PEmax) through the use of an analog manometer (GERAR®, São Paulo, Brazil) with an operating range of ± 300 cmH2O and equipped with a mouthpiece adapter, containing an exhaust valve through an orifice of approximately 2mm in diameter to prevent the increase of intraoral pressure. For data analysis, at least three reproducible maneuvers will be used, with variability less than 20%, and the highest value will be recorded. The normality references for the calculation of maximal respiratory pressures as a function of age and gender will respect the description of the method used by Pessoa et al. (2014) for the Brazilian population. |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Primary |
Dyspnea - Medical Research Council |
Dyspnea will be assessed using the scale adapted to Portuguese by the Medical Research Council. The scale will allow the volunteer to indicate the extent to which their shortness of breath affected their mobility in daily activities. The scores range from 1 to 5, whose higher values refer to greater dyspnea, and the lower values reflect less dyspnea and will be chosen by the participant (BESTALL et al., 1999). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Primary |
Quality of life (SF-36) |
The Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) is a multidimensional questionnaire translated and validated for the Brazilian reality (CICONELLI et al., 1999; LAGUARDIA et al., 2011) that was developed to assess quality of life related to health. Scores range from 0 to 100 for each subscale, with higher scores being indicative of a better health-related quality of life (WARE; SHERBOURNE, 1992). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Pulmonary function |
All participants will undergo an evaluation by a Koko Digidoser model spirometer (Spide, Longmont, USA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Exercise tolerance |
The six-minute walk test assesses a submaximal level of functional capacity during exercise, measuring the distance a patient can walk on a flat surface of 30 meters for six minutes. At the end of the six minutes the number of laps will be registered and a marker placed on the floor beside the subject (ATS, 2002). The distance covered in the last lap will be measured by a tape measure and the total distance obtained by multiplying the number of laps by the measure of space and adding the distance covered in the last lap (ATS, 2002). The method to assess the predicted distance will follow the equations proposed in the literature, based on the gender, weight, age and height of the participants (ENRIGHT; SHERRILL, 1998). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Functional status |
The post-covid-19 functional status scale assesses relevant aspects of daily life during follow-up after infection. The scale contains six items ranging from zero to five and comprises the full range of functional outcomes with a focus on limitations of tasks and activities of daily living (home, work/study and lifestyle changes). The general classification corresponds to the worst functional status indicated by the patients' responses (the highest degree corresponding to the greatest limitations) (KLOK et al., 2020). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Anxiety and depression |
Depression Self-Rating Scales (SDS) and Anxiety Self-Rating Scale (SAS) will be explored to assess depression and anxiety in groups. Both the SDS and the SAS have 20 items, each of which will be scored on a scale of 1-4, and the higher the score, the more severe the degree of depression and anxiety (ZUNG, 1991). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Peripheral muscle strength |
The handgrip strength will be measured with the manual hydraulic dynamometer (Saehan®). It will be quantified by measuring the amount of maximum isometric force that the dominant hand can squeeze the dynamometer. The cut-off point will be <27kg for men and <16kg for women (CRUZ-JENTOFT et al., 2019). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Adverse effects and adherence |
For the assessment of adverse effects, a training diary will be provided to all study volunteers, in which all training days they must take will be provided and a blank space for positive and/or negative observations and to record any complications during and/or after training sessions. For analysis of adherence to training will be considered every time they mark the tables signaling the performance of the session. The sum of all sessions made will be carried out and these will be divided by the total number of sessions that the participants must do. |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Physical activity level |
The level of physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). The long version of the IPAQ (ANNEX 5), adapted (MAZO; BENEDETTI, 2001) and validated for the Brazilian population (BENEDETTI et al., 2008) comprises 5 domains and 15 questions. Participants will be classified as very active, active, irregularly active and sedentary (MATSUDO et al., 2002). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Cognition |
The Mini Mental State Examination (MMSE) will be used for cognitive screening in the elderly. It consists of two sections that assess cognitive functions. The final score is 30 points. Higher score values indicate greater cognitive performance (FOLSTEIN et al., 1975). The proposed cutoff scores will be used to minimize the influence of the level of education on the total scores (BERTOLUCCI et al., 1994). |
baseline |
|
Secondary |
Perception of effort and fatigue |
Individuals will be asked separately about their subjective perception of effort during breathing and fatigue in the lower limbs. To quantify it was the modified Borg RPE scale. The scale had numerical values from 0 to 10 and expressions that classify the degree of difficulty, whose higher values reflect a greater feeling of breathlessness (BORG, 2007). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|
Secondary |
Functional independence measure |
The FIM is a scale used to analyze the individual's performance to perform Basic Activities of Daily Living (ABVD) and Instrumental Activities of Daily Living (IADL) in a set of 18 tasks, related to the motor domains (self-care, sphincter control, transfers and locomotion). Thus, the total scale score ranges from eighteen points to one hundred and twenty-six points, with a classification of severe functional impairment (18-36 points), moderate (37-89 points), mild (90-126 points) (Riberto et al. 2004). |
Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks. |
|