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| ID | Type | Description | Link |
|---|---|---|---|
| PID2023-150311OB-I00 | Other Grant/Funding Number | Ministerio de Ciencia, Innovación y Universidades |
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| Name | Class |
|---|---|
| Loyola University | OTHER |
| University of Thessaly | OTHER |
| Hospital Materno-Infantil Torrecárdenas de Almería | UNKNOWN |
| Hospital Universitario Reina Sofia de Cordoba |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 6-months of live and online progressive resistance training plus impact loading + dietary counselling on calcium and vitamin D. |
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| Control group | No Intervention | Dietary counselling on calcium and vitamin D. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive resistance training plus impact loading | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 6 months |
| Change in Cortical Bone Thickness (pQCT) | Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images. | Baseline and 6 months |
| Change in Periosteal and Endocortical Circumference (pQCT) | Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm) | Baseline and 6 months |
| Change in Cross-Sectional Moment of Inertia-CSMI (pQCT) | CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴). | Baseline and 6 months |
| Change in Bone strehgth indices (pQCT) | Bone strehgth indices at tibia and radius will be obtained from pQCT images | Baseline and 6 months |
| Change in Bone Mineral Content (DXA) | BMC will be assessed using DXA at whole-body and regional sites (g) | Baseline and 6 months |
| Change in Areal Bone Mineral Density (DXA) | Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²) | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass | Measured with electronic scale (kg). | Baseline and 6 months |
| Change in Height | Measured with stadiometer (cm). | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in objective strength | Objective strength will be measured with a functional electromechanical dynamometer-DynaSystem (kg) | Baseline and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Ubago Guisado, Ramón y Cajal researcher | Contact | +34 958246644 | estherug@ugr.es | |
| Luis Gracia Marco, Senior Lecturer | Contact | +34 958244363 | lgracia@ugr.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada | Granada | Andalusia | 18007 | Spain |
Data files including IPD and corresponding data dictionaries will be shared under restricted access and upon reasonable request (E Ubago-Guisado or L Gracia-Marco) due to privacy issue and GDPR regulations. In principle, all collected IPD will be available for sharing under the "as open as possible, as closed as necessary" principle. The shared data files will be pseudonymized, only include participants who provided informed consent for sharing, and sharing is only possible when the data is used for research purposes. This is stated at the informed consent files that the participants signed when they agree to participate.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| D055948 | Sarcopenia |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| OTHER_GOV |
| University Hospital Virgen de las Nieves | OTHER |
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| Change in Cross-Sectional Area (DXA-HSA) | Derived from hip structural analysis (mm²). | Baseline and 6 months |
| Change in Section Modulus (DXA-HSA) | Indicates bone strength; calculated from HSA (mm³). | Baseline and 6 months |
| Change in Cross-Sectional Moment of Inertia (DXA-HSA) | Assesses resistance to bending forces (mm⁴). | Baseline and 6 months |
| Change in Trabecular Bone Score (TBS) | Lumbar spine texture will be assessed using TBS (TBS index). | Baseline and 6 months |
| Change in Serum Lipid Profile | Cholesterol, triglycerides, HDL, LDL levels (mg/dL). | Baseline and 6 months |
| Change in Total bilirubin | mg/dL | Baseline and 6 months |
| Change in Calcium | mg/dL | Baseline and 6 months |
| Change in Creatinine | mg/dL | Baseline and 6 months |
| Change in Phosphorus | mg/dL | Baseline and 6 months |
| Change in Glucose | mg/dL | Baseline and 6 months |
| Change in Magnesium | mg/dL | Baseline and 6 months |
| Change in Uric acid | mg/dL | Baseline and 6 months |
| Change in ALT/GPT | U/L | Baseline and 6 months |
| Change in Na/K/Cl | mEq/L | Baseline and 6 months |
| Change in Albumin | g/dL | Baseline and 6 months |
| Change in Total protein | g/dL | Baseline and 6 months |
| Change in Serum 25(OH) Vitamin D | ng/mL | Baseline and 6 months |
| Change in Alkaline phosphatase | U/L | Baseline and 6 months |
| Change in Bone specific alkaline phosphatase | ng/mL | Baseline and 6 months |
| Change in Glycosylated hemoglobin | mmol/mol | Baseline and 6 months |
| Change in Parathyrin | pg/mL | Baseline and 6 months |
| Change in Thyrotropin | µUI/mL | Baseline and 6 months |
| Change in Gamma-glutamyl transferase | U/L | Baseline and 6 months |
| Change in β-CTX (Serum) | Marker of bone resorption (ng/mL) | Baseline and 6 months |
| Change in PINP (Serum) | Marker of bone formation (ng/mL) | Baseline and 6 months |
| Change in Irisin (Serum) | ng/mL | Baseline and 6 months |
| Change in Sclerostin (Serum) | ng/mL | Baseline and 6 months |
| Change in Body Mass Index (BMI) | Calculated as kg/m². | Baseline and 6 months |
| Change in Blood Pressure | Systolic and diastolic pressure measured in mmHg. | Baseline and 6 months |
| Change in body circumferences | Waist, hip and neck circumferences measured in cm. | Baseline and 6 months |
| Change in Lean Soft Tissue Mass (DXA) | Assessed at whole-body using DXA (g). | Baseline and 6 months |
| Change in Fat Mass (DXA) | Assessed at whole-body using DXA (kg). | Baseline and 6 months |
| Change in Body Fat Percentage (DXA) | Assessed at whole-body using DXA (%). | Baseline and 6 months |
| Change in 6-Minute Walk Test | Distance walked in 6 minutes (meters). | Baseline and 6 months |
| Change in Squat Jump Test | Height achieved in the test (cm). | Baseline and 6 months |
| Change in Handgrip Strength Test | Maximal grip force (kg). | Baseline and 6 months |
| Change in Standing Long Jump Test | Distance achieved in the test (cm). | Baseline and 6 months |
| Change in 5 Times Sit-to-Stand Test | Time to complete 5 repetitions (seconds) | Baseline and 6 months |
| Change in 4-m Gait Speed Test | Time to walk 4 meters (seconds) | Baseline and 6 months |
| Change in Self-Reported Fitness (IFIS) | Perceived fitness using IFIS questionnaire. | Baseline and 6 months |
| Change in Sarcopenia Classification (EWGSOP2) | Sarcopenia will be classified as no, probable, or confirmed based on grip strength, sit-to-stand time, and appendicular lean mass by DXA. Categorical (no/probable/confirmed). | Baseline and 6 months |
| Change in Frailty Status | Frailty will be assessed using five criteria: low muscle mass, fatigue, low physical activity, slowness, and weakness. Categorical (frail/non-frail). | Baseline and 6 months |
| Change in Physical Activity and Sedentarism (Accelerometer) | Measured over 7 consecutive days using ActiGraph (counts per minute). | Baseline and 6 months |
| Change in Self-Reported Physical Activity (IPAQ) | Activity levels using the IPAQ (MET-min/week) | Baseline and 6 months |
| Change in Bone-Specific Physical Activity (BPAQ) | Scored from the BPAQ questionnaire (BPAQ score) | Baseline and 6 months |
| Change in Calcium Intake | Estimated using validated short calcium questionnaire (mg/day). | Baseline and 6 months |
| Change in Vitamin D Intake | Estimated from dietary questionnaire (IU/day). | Baseline and 6 months |
| Change in Mediterranean Diet Adherence | Calculated from validated adherence questionnaire (Score 0-14) | Baseline and 6 months |
| Change in Quality of Life | HRQoL from the SF-36 questionnaire (0-100 scale). | Baseline and 6 months |
| Change in Anxiety and Depression (HADS) | Anxiety and depression score from HADS (Score 0-21) | Baseline and 6 months |
| Change in Self-Esteem (Rosenberg Scale) | Assessed using Rosenberg Self-Esteem Scale (Score 0-30) | Baseline and 6 months |
| Change in Perceived Stress (PSS) | Assessed via Perceived Stress Scale (Score 0-40). | Baseline and 6 months |
| D009422 |
| Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010549 | Personal Satisfaction |