COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5d7hkv

Atila Trapé

atrape@usp.br

2020-11-03

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

Participants women and men aged between 30 and 69 years convalescent from COVID-19 (having the test with a positive diagnosis), having moderate to severe symptoms, approximately 30 days since recovery from clinical signs or medical discharge (if you have been hospitalized), have previous experience in aerobic physical activity.

Exposure to high places (altitude greater than 1500 m) in the last three months, significant physical limitations to carry out evaluations and intervention, acute or chronic clinical illnesses without medical supervision, anemia, use of immunosuppressive drugs, pregnant women, hormone replacement, smokers, excessive use of alcohol or drugs.

4

Escola de Educação Física e Esporte de Ribeirão Preto

30

69

Brazil

Patients recovered from covid

N/A

0

For all primary and secondary outcomes; parameters will be presented in absolute numbers and the pre and post-intervention comparisons in percentages (delta). When necessary; categories will be used to express the results.Improvements in lung functionFor pulmonary function evaluation; a portable spirometer (Micro Medical; Rochester; United Kingdom) will be used; following the current standards46 and guidelines for pulmonary function tests. Participants will be instructed to perform the maneuvers to assess forced vital capacity (FVC) and forced expiratory volume (FEV).;Improvements in inflammatory mediators and hematological parametersDosage of inflammatory soluble protein mediatorsThe quantification of cytokines IL-6; IL-8; IL-10; and TNF-alpha will be performed by the ELISA - Multiplex method (R&D Systems; Billings; USA).Inflammatory lipid mediatorsThe profiles of eicosanoids and endocannabinoids will be evaluated in plasma by mass spectrometry in samples collected with EDTA anticoagulant at the facility available from FCFRP - USP. The standard protocol with solid-phase extraction (SPE) and the identification and quantification of eicosanoids and endocannabinoids will be used. Data acquisition and processing will be performed using PeakViewTM and MultiQuantTM software (Sciex; Foster; CA; USA) (Sorgi CA; et al; Scientific Data; 2018).Hematological parametersHemogram parameters; such as total erythrocyte count; hematocrit; hemoglobin concentration; mean corpuscular volume; mean corpuscular hemoglobin; mean corpuscular hemoglobin concentration; total leukocyte; platelet; and reticulocyte count will be evaluated. Total cholesterol; triglycerides; HDL-c; LDL-c; lactic dehydrogenase; and liver enzymes (TGO and TGP) will also be analyzed. The collection will be carried out at EEFERP by a trained and specialized professional. Later; the samples will be sent for analysis at the Clinical Analysis Laboratory of FCFRP - USP; according to the technical service's standard routine and methodology. To determine the EPO concentration in the plasma samples; the EPO Immunoassay ELISA Kit will be used.;Improvements in autonomic parametersHR variability will be analyzed by acquisition at each beat to determine RR intervals and analyze autonomic variables. These responses will be subjected to digital filtering performed by the device's software (Polar Precision Performance; version 3.0) by identifying and correcting some ectopic beats (irregularities in heart rhythm); involving extrasystole and consecutive compensatory pause. The analysis of HR variability will be performed by linear methods; analyzed in the domains of time (SDNN and RMSSD) and frequency (LF; HF; and LF/HF ratio). The spectral analysis will be calculated using the Fast Fourier Transform algorithm.;Improvements in body compositionFor the analysis of body composition and the distribution of lean; bone; and adipose tissue; the dual-energy X-ray absorptiometry technique (iDXA - GE Lunar - DPX-NT) will be used. The radiation dose that the participants will receive will be less than 0.0545; equivalent to 50 times less than an X-ray exam. When positioned on the device; the subjects will remain immobile in the supine position during the exam (about 15 min). The method will estimate body composition by dividing the body into three anatomical compartments: fat-free mass; fat mass and bone mineral content.;Improvements in maximum aerobic power (VO2max) and anaerobic threshold (AT) An incremental test will be used to estimate AT; VO2max; and iVO2max. The warm-up will be 5 min in cycle ergometer (E200; COSMED; Italy) without load (0 Kp). At each 2-minute stage; there will be an increase of 0.25 Kp (approximately 13 W) until voluntary exhaustion27. O2 consumption will be measured with each breath; using the gas analyzer (Quark - PFT®; COSMED; Italy); which will be calibrated according to the manufacturer's specifications. Blood samples (25 ?L) will be collected from the earlobe at each stage's end to analyze the blood [La-]. Concomitantly; HR and PSE will be monitored at the end of each stage. VO2max will be defined as the highest mean VO2 in the last 60 s in the test; considering at least three of the criteria: volitional exhaustion; blood [La-] ? 8.0 mmol;> 90% of the maximum HR predicted for age (HRmax = 220 - age); PSE ? 9; respiratory quotient ? 1.10; inability to maintain a frequency of at least 60 rpm. The iVO2max will be the lowest intensity at which the individual reaches VO2max during the test. If the individual doesn't sustain the intensity until the stage's end; the iVO2max will be assumed like peak power (PP); estimated by equation.A partial evaluation containing the incremental test will be carried out at week 5 (half of the intervention) to adjust the training load (evaluation 2). Therefore; the incremental test will be performed in four moments: evaluation 1 (week 0 - pre); evaluation 2 (week 5 - half of the intervention); evaluation 3 (week 9 - post); and evaluation 4 (week 13 - four after the end) intervention).

Not reported

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