protocolSection identificationModule nctId: NCT06330922, orgStudyIdInfo id: 10.55776/V992, briefTitle: Muscle-tendon Pathology and Metabolic Dysregulation in CP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Graz, class: OTHER, collaborators name: Medical University of Graz, collaborators name: Karolinska Institutet, descriptionModule briefSummary: The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated.The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners).To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners., conditionsModule conditions: Cerebral Palsy, Spastic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiorespiratory fitness training, outcomesModule primaryOutcomes measure: Muscle fascicle length and muscle thickness, primaryOutcomes measure: Muscle fascicle pennation angle, primaryOutcomes measure: Passive muscle stiffness, primaryOutcomes measure: Isometric muscle strength, primaryOutcomes measure: Muscle tissue oxygenation, primaryOutcomes measure: Exosome size, primaryOutcomes measure: Exosome content, primaryOutcomes measure: Micro ribonucleic acid (RNA) cargo, secondaryOutcomes measure: Metabolic parameters, secondaryOutcomes measure: Pro-inflammatory cytokines, secondaryOutcomes measure: Resting, mean, and peak heart rate, secondaryOutcomes measure: Resting blood pressure, secondaryOutcomes measure: Distance covered, secondaryOutcomes measure: Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak), secondaryOutcomes measure: Peak respiratory frequency, secondaryOutcomes measure: Respiratory exchange ratio, secondaryOutcomes measure: VEpeak/VO2peak, secondaryOutcomes measure: VEpeak/VCO2peak, secondaryOutcomes measure: Perceived exertion, secondaryOutcomes measure: Well-being and quality of life, secondaryOutcomes measure: Total physical activity, time spent in different intensities, secondaryOutcomes measure: Passive range of motion (sagittal plane) of hip, knees, ankles, secondaryOutcomes measure: Step count, otherOutcomes measure: Body height, otherOutcomes measure: Body weight, otherOutcomes measure: Body mass index (BMI), otherOutcomes measure: Modified Ashworth Scale Score of the Plantar flexors, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Human Movement Science, Sport and Health, University of Graz, status: RECRUITING, city: Graz, zip: 8010, country: Austria, contacts name: Sebastian Ruin, Univ.-Prof., role: CONTACT, phone: 00433163802336, email: sebastian.ruin@uni-graz.at, geoPoint lat: 47.06667, lon: 15.45, hasResults: False