Cystic Fibrosis
Conditions
Interventions
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,
Sponsors
Hospital Universitário Lauro Wanderley/HULW, Universidade Federal da Paraíba/UFPB
Hospital Universitário Lauro Wanderley/HULW, Universidade Federal da Paraíba/UFPB
Eligibility
Age
5 Years to 18 Years
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: Participants who do not perform all procedures; experience gastric discomfort with ingestion of grape juice during the study; present changes in kidney or liver function; have intolerance to physical training
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactAna Carla de França
Universidade Federal da Paraíba
Outcome results
None listed