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