Virtual Exercise Training and Its Impact on Bone Compartments in Adult Survivors of Childhood Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Progressive resistance training plus impact loading: 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.

Study summary

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

Primary outcome measure(s)

• Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT) — Baseline and 6 months
  Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³).
• Change in Cortical Bone Thickness (pQCT) — Baseline and 6 months
  Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images.
• Change in Periosteal and Endocortical Circumference (pQCT) — Baseline and 6 months
  Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm)
• Change in Cross-Sectional Moment of Inertia-CSMI (pQCT) — Baseline and 6 months
  CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).
• Change in Bone strehgth indices (pQCT) — Baseline and 6 months
  Bone strehgth indices at tibia and radius will be obtained from pQCT images
• Change in Bone Mineral Content (DXA) — Baseline and 6 months
  BMC will be assessed using DXA at whole-body and regional sites (g)
• Change in Areal Bone Mineral Density (DXA) — Baseline and 6 months
  Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²)
• Change in Cross-Sectional Area (DXA-HSA) — Baseline and 6 months
  Derived from hip structural analysis (mm²).
• Change in Section Modulus (DXA-HSA) — Baseline and 6 months
  Indicates bone strength; calculated from HSA (mm³).
• Change in Cross-Sectional Moment of Inertia (DXA-HSA) — Baseline and 6 months
  Assesses resistance to bending forces (mm⁴).
• Change in Trabecular Bone Score (TBS) — Baseline and 6 months
  Lumbar spine texture will be assessed using TBS (TBS index).
• Change in Serum Lipid Profile — Baseline and 6 months
  Cholesterol, triglycerides, HDL, LDL levels (mg/dL).
• Change in Total bilirubin — Baseline and 6 months
  mg/dL
• Change in Calcium — Baseline and 6 months
  mg/dL
• Change in Creatinine — Baseline and 6 months
  mg/dL
• Change in Phosphorus — Baseline and 6 months
  mg/dL
• Change in Glucose — Baseline and 6 months
  mg/dL
• Change in Magnesium — Baseline and 6 months
  mg/dL
• Change in Uric acid — Baseline and 6 months
  mg/dL
• Change in ALT/GPT — Baseline and 6 months
  U/L
• Change in Na/K/Cl — Baseline and 6 months
  mEq/L
• Change in Albumin — Baseline and 6 months
  g/dL
• Change in Total protein — Baseline and 6 months
  g/dL
• Change in Serum 25(OH) Vitamin D — Baseline and 6 months
  ng/mL
• Change in Alkaline phosphatase — Baseline and 6 months
  U/L
• Change in Bone specific alkaline phosphatase — Baseline and 6 months
  ng/mL
• Change in Glycosylated hemoglobin — Baseline and 6 months
  mmol/mol
• Change in Parathyrin — Baseline and 6 months
  pg/mL
• Change in Thyrotropin — Baseline and 6 months
  µUI/mL
• Change in Gamma-glutamyl transferase — Baseline and 6 months
  U/L
• Change in β-CTX (Serum) — Baseline and 6 months
  Marker of bone resorption (ng/mL)
• Change in PINP (Serum) — Baseline and 6 months
  Marker of bone formation (ng/mL)
• Change in Irisin (Serum) — Baseline and 6 months
  ng/mL
• Change in Sclerostin (Serum) — Baseline and 6 months
  ng/mL

Trial sites (1)

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