Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.
Age range
6 Years – 20 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Changes in peripheral muscle strength
Timeframe: Baseline, pre-intervention and immediately after the intervention.
Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O)
Timeframe: Baseline, pre-intervention and immediately after the intervention
Changes in functional capacity: lower limbs power capacity
Timeframe: Baseline, pre-intervention and immediately after the intervention
Changes in functional capacity: walking capacity
Timeframe: Baseline, pre-intervention and immediately after the intervention
Change in Cardiorespiratory fitness: maximal oxygen consumption
Timeframe: Baseline, pre-intervention and immediately after the intervention
Change in Cardiorespiratory fitness: Ventilatory threshold VT1
Timeframe: Baseline, pre-intervention and immediately after the intervention