Material and Methods
tumor necrosis, Peripheral venous blood samples, shoulder abductors, hemoptysis, trauma
TUMOR NECROSIS, PNEUMOTHORAX, CYSTIC FIBROSIS, THORACIC, HEMODYNAMIC INSTABILITY, BLOOD, COMPLICATIONS
This randomized controlled trial was approved by the HCPA Research Ethics Committee (15-0443) and was registered in the Clinical Trials platform (NCT03100214). All patients gave consent prior to inclusion.The study included patients diagnosed with CF according to consensus criteria (Exclusion criteria were cardiac, orthopedic, or trauma complications that precluded exercise performance, pregnancy, hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.Initially, general information such as gender, age, age at diagnosis, body mass index (BMI), and bacteriology were collected. Then, the Cystic Fibrosis Questionnaire Revised (CFQ-R) (After the interview and initial data collection, the patients underwent the following evaluations: spirometry, maximal one repetition test (1RM), the six-minute walk test (6MWT), and a C-reactive protein (CRP) assay. These evaluations were performed within 24 h of admission and again on the 14th day of hospitalization.Spirometry was performed at the Pulmonary Physiology Unit of the HCPA Pulmonology Service with a Jaeger 4.31a spirometer (Germany) according to the Brazilian Society of Pulmonology and Phthisiology technical criteria (Functional capacity assessment was performed at the HCPA Pulmonology Service using the 6MWT according to the American Thoracic Society and European Respiratory Society guidelines (To measure muscle strength, the 1RM test was used, i.e., the maximum amount of weight that the patient could lift once during a standardized weightlifting exercise (Peripheral venous blood samples were collected from all subjects in coated tubes. Blood samples were centrifuged for 15 min at 4°C and 302 Serum levels of inflammatory cytokines interleukin (IL)-1, IL-6, IL-10, IL-17, and tumor necrosis factor (TNF)-α were measured by Multiplex Bead Immunoassay, using Human Magnetic Custom Luminex Kit by the Luminex system 200 (Invitrogen by Life Technologies, USA). All analyses were performed in duplicate using commercial assays and in accordance with the manufacturer's recommendations.Within 48 h of hospitalization, the patients were randomized to either the intervention or control group. Randomization was performed with the Research Randomizer (The exercise group, besides receiving the same monitoring as the control group, also received physical training through the early rehabilitation program, which began within 48 h of hospitalization. The patients underwent supervised physical training 5 times per week for 14 days, with sessions lasting between 45 min and 1 h. The individual who performed the outcome assessments was blinded to group allocation.The aerobic exercise intensity was based on the 6MWT results, kept within a target range of 80% of the test speed. The exercise was performed on a treadmill with a desired duration of 30 min.The intensity of anaerobic exercise was calculated based on the 1RM test results, kept within a range of 30-40% of the maximum load. Patients performed three sets of 10 repetitions for the following muscle groups: biceps, triceps, shoulder abductors, shoulder flexors, hamstrings, and quadriceps.Patients randomized to the control group continued to be monitored by the entire team from the HCPA Program for Adolescents and Adults with CF (physician, nutritionist, psychologist, and physiotherapist) throughout their hospitalization. Supervised physiotherapy included respiratory therapy, which involved inhalation therapy and secretion removal techniques.SPSS version 22.0 (IBM, USA) was used to process and analyze the data. A descriptive analysis of the study variables in each group was performed. Quantitative data are reported as means±SD or median (interquartile range). Qualitative data are reported as n (% of all cases). For the comparison between groups, a The sample size was calculated following Ziegler et al. (