About this trial
Childhood cancer is a rare disease but a significant cause of death in children and adolescents. The incidence of childhood cancer is 1case per 300 cases of adult cancer, but surviving to it has important sequels. Endocrine dysfunction represents one of the most common issues in paediatric cancer survivors and impairs bone mineral density later in life. Some forms of exercise have been recommended to preserve bone health in healthy adults; however, its effect has not been properly studied yet in adult survivors of paediatric cancer using cutting-edge technologies, such as peripheral quantitative computed tomography (pQCT). As general aim, the 3D-BONE study will assess for the first time the effect of a live and online exercise programme on bone parameters and bone metabolism in adult survivors of paediatric cancer. This multicenter randomized controlled trial will be performed in three Andalusian provinces (Granada, Cordoba and Almeria). A minimum of 116 adult survivors of paediatric cancer aged 18 to 55 years will be recruited following the inclusion and exclusion criteria. They will be randomized (based on sex and age) into an INTERVENTION (n=58) or CONTROL group (n=58). The intervention group will receive a 6-month live and online exercise program based on progressive resistance and impact loading training that will be delivered by qualified professionals using a telehealth mobile app (3D-BONE app). Moreover, behaviour change techniques will be implemented in order to increase motivation and adherence to the program. This group will also receive diet counselling on calcium and vitamin so the difference between the groups is the exercise programme. Participants will be assessed before and after the intervention at the facilities of the Sport and Health University Research Institute (iMUDS) of the University of Granada. An in-depth analysis of bone parameters will be carried out using cutting-edge technologies, such as the pQCT (to analyse cortical and trabecular bone in 3 dimensions), dual-energy X-ray absorptiometry (DXA), hip and lumbar spine geometry outcomes. Moreover, a complete blood count will be obtained and markers of bone metabolism will be measured (B-CTX, PINP), including novel markers such as sclerostin and irisin which have recently been linked to human bone. Data will also be collected in anthropometry and body composition to obtain cardiovascular risk factors, sarcopenia and physiologic frailty risk factors, mental health, health-related quality of life and objective measures of physical activity and fitness. This will ensure obtaining novel, precise and strong data in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).
18-55 years of age at recruitment
Disqualifiers
Participation in another research study simultaneously.
Not currently receiving cancer treatment.
Previous diagnosed anorexia/bulimia, known pregnancy, known alcohol or drug abuse.
Requiring chronic oral glucocorticoid therapy.
Trial design
Parallel
Treatments tested in this trial
Progressive resistance training plus impact loading
BehavioralThe intervention will be performed 3 days a week (Monday, Tuesday and Thursday \[group 1\] and Monday, Wednesday and Thursday \[group 2\]), following previous studies. Each section will last 45 minutes, comprising 10 minutes of warm-up, 20 minutes of resistance training, 10 minutes of impact exercises, and 5 minutes of cool down. There will always be a minimum of 24-hour interval between exercise sessions, and an extra training day (Friday) will be available if participants miss a training day in the respective week. The exercise periodisation will be composed by 3 phases (phase 1, phase 2 and phase 3). Across phases, training volume will vary and a progressively increase in exercise intensity will be applied in each phase. The three phases of the study will consist of 8 weeks, and within each phase the participants will perform six different training sessions.
Treatment groups
Trial outcomes
Primary outcomes
Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)
Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³).
Change in Cortical Bone Thickness (pQCT)
Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images.
Change in Periosteal and Endocortical Circumference (pQCT)
Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm)
Change in Cross-Sectional Moment of Inertia-CSMI (pQCT)
CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).
Secondary outcomes
Change in Body Mass
Measured with electronic scale (kg).
Change in Height
Measured with stadiometer (cm).
Change in Body Mass Index (BMI)
Calculated as kg/m².
Change in Blood Pressure
Systolic and diastolic pressure measured in mmHg.
Other outcomes
Change in objective strength
Objective strength will be measured with a functional electromechanical dynamometer-DynaSystem (kg)
Sponsors and contacts
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Universidad de Granada
Lead sponsor
Loyola University
Collaborator
University of Thessaly
Collaborator
Hospital Materno-Infantil Torrecárdenas de Almería
Collaborator
Hospital Universitario Reina Sofia de Cordoba
Collaborator
University Hospital Virgen de las Nieves
Collaborator
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