protocolSection identificationModule nctId: NCT06300515, orgStudyIdInfo id: PI23/00396, briefTitle: Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation, acronym: HENKO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Alejandro Lucia, class: OTHER, collaborators name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, collaborators name: Hospital General Universitario Gregorio Marañon, collaborators name: Hospital Universitario La Paz, collaborators name: Hospital Universitario 12 de Octubre, descriptionModule briefSummary: Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units., conditionsModule conditions: Hematopoietic System--Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The staff in charge of outcome assessment will be blinded to the group assigned to each participant., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Control Group (Active Comparator), interventions name: Intervention Group, outcomesModule primaryOutcomes measure: Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up, primaryOutcomes measure: Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up, secondaryOutcomes measure: Change in isometric leg muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in dynamic lower-limb muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in upper-limb muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in respiratory muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in the 'ventilatory threshold' (VT) from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) ejection fraction from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) fractional shortening from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up, secondaryOutcomes measure: Change in total cardiac mass from baseline to follow-up, secondaryOutcomes measure: Change in functional mobility (stairs test) from baseline to follow-uo, secondaryOutcomes measure: Change in functional mobility (chair rising) from baseline to follow-up, secondaryOutcomes measure: Change in functional mobility (Quick Function test) from baseline to follow-up, secondaryOutcomes measure: Change in body mass index (BMI) from baseline to follow-up, secondaryOutcomes measure: Change in adiposity index from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up, secondaryOutcomes measure: Change in physical activity (PA) from baseline to end of treatment, secondaryOutcomes measure: Change in ankle-dorsiflexion from baseline to end of treatment, secondaryOutcomes measure: Change in psychological status (health-related quality of life) from baseline to follow-up, secondaryOutcomes measure: Change in psychological status (fatigue) from baseline to follow-up, secondaryOutcomes measure: Change in lymphocyte subpopulations from baseline to follow-up, secondaryOutcomes measure: Change in immune phenotype from baseline to follow-up, secondaryOutcomes measure: Change in survival from baseline to follow-up, secondaryOutcomes measure: Change in treatment tolerability from baseline to follow-up, secondaryOutcomes measure: Change in treatment toxicities from baseline to follow-up, secondaryOutcomes measure: Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hospital 12 de Octubre, city: Madrid, zip: 28041, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False