Effects of physical exercise and red grape juice on oxidative stress, inflammation and cardiac autonomic modulation in patients with Cystic Fibrosis

INTERVENTION: This is a randomized, double‐blind, cross‐over clinical trial. The 12 patients were randomized (www.randomizer.org) to begin the procedures. The duration of the physical training protocol is 12 weeks, three times a week (30 to 40 minutes). To monitor the intensity of the sessions, an elastic strap with a Bluetooth® heart rate transmitter (Polar H10, Polar Electro Oy, Kempele, Finland) was used. During the exercise session, the modified Borg Subjective Perceived Exertion Scale (PSE) was used, with indices from 0 to 10 so that patients become familiar with the stages of fatigue that range from very mild to exhausting (NOBLE et al. , 1983). Heart rate (HR) and Subjective perceived exertion (PSE) were questioned every 10 minutes. The intensity of home sessions was monitored using the modified Borg Subjective Perceived Exertion Scale (PSE). As for supplementation, the protocol was 14 days, with 10 mL/kg/day of whole red grape juice or placebo drink. According to the manufacturers, each 200 mL of Garibaldi red grape juice (Garibaldi, Serra Gaúcha, Brazil) contains 130 kcal and 32 g of carbohydrates. While the grape‐based placebo drink has 140 kcal and 33 g of carbohydrates. Do not contain significant amounts of protein, fat, dietary fiber or sodium CONDITION: Cystic Fibrosis G03.673 PRIMARY OUTCOME: Expected outcome: Investigate cardiac autonomic modulation in response to physical training in children and adolescents with Cystic Fibrosis, the physical training protocol will occur for 12 weeks, three times a week (30 to 40 minutes), the method to determine autonomic activity heart rate will be by recording the variability of the R‐R heart rate interval, measured by an Android® smartphone with the HRV Expert by CardioMood® application (CardioMood, Moscow, Russia), where participants will be instrumented with an elastic strap with a Bluetooth transmitter ® (Polar H10, Polar Electro Oy, Kempele, Finland), it is expected that there will be an improvement in cardiac autonomic modulation in response to physical training in children and adolescents with Cystic Fibrosis Expected outcome: To investigate the ability to modulate heart rate variability in response to red grape juice supplementation in children and adolescents with Cystic Fibrosis, the supplementation protocol will be 14 days with 10 mL/kg/day of whole red grape juice or drink placebo., the method to determine cardiac autonomic activity will be by recording the variability of the R‐R interval of heart rate, measured by an Android® smartphone with the HRV Expert by CardioMood® application (CardioMood, Moscow, Russia), where participants will be instrumented with an elastic strap with a Bluetooth® heart rate transmitter (Polar H10, Polar Electro Oy, Kempele, Finland), it is expected that there will be an improvement in cardiac autonomic modulation in response to whole red grape juice in children and adolescents with Cystic fibrosis; SECONDARY OUTCOME: No secondary outcomes are expected INCLUSION CRITERIA: Diagnosis of Cystic Fibrosis by positive sweat test and/or presence of one or more mutations in the cystic fibrosis transmembrane regulatory gene (CFTR) ; not being indicated for or having undergone lung transplantation; no renal or hepatic dysfunction; be between 5 and 18 years old; do not regularly consume red grape juice, as well as food supplements that contain bioactive substances present in grapes (polyphenols)