protocolSection identificationModule nctId: NCT06322446, orgStudyIdInfo id: PI23/00299, briefTitle: Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy, acronym: FIQMODE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-12-23, completionDateStruct date: 2025-12-23, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universidad Politecnica de Madrid, class: OTHER, collaborators name: Carlos III Health Institute, collaborators name: Universidad Europea de Madrid, collaborators name: Hospital Universitario La Paz, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, descriptionModule briefSummary: 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., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Changes in peripheral muscle strength, primaryOutcomes measure: Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O), primaryOutcomes measure: Changes in functional capacity: lower limbs power capacity, primaryOutcomes measure: Changes in functional capacity: walking capacity, primaryOutcomes measure: Change in Cardiorespiratory fitness: maximal oxygen consumption, primaryOutcomes measure: Change in Cardiorespiratory fitness: Ventilatory threshold VT1, secondaryOutcomes measure: Changes in Pulmonary Function: forced vital capacity (FVC), secondaryOutcomes measure: Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1), secondaryOutcomes measure: Changes in the anthropometric and body composition: Weight, secondaryOutcomes measure: Changes in the anthropometric and body composition: Height, secondaryOutcomes measure: Changes in the anthropometric and body composition: BMI, secondaryOutcomes measure: Changes in body composition: Total fat mass, secondaryOutcomes measure: Changes in body composition: FMI, secondaryOutcomes measure: Changes in body composition: lean mass kg, secondaryOutcomes measure: Changes in body composition: lean mass %, secondaryOutcomes measure: Changes in quality of life using the Cystic Fibrosis Questionnaire, secondaryOutcomes measure: Changes in plasma levels muscle damage biomarkers, secondaryOutcomes measure: Changes in plasma levels of inflammation: hs-CRP, secondaryOutcomes measure: Changes in plasma levels of inflammation: Interleukins, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Marcela González Gross, PhD, role: CONTACT, phone: +34910677980, email: marcela.gonzalez.gross@upm.es, contacts name: Margarita M Pérez-Ruiz, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marcela González-Gross, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False