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NCT Number: NCT07022262

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada

Granada, Andalusia, 18007, Spain

Location contact

Esther Ubago Guisado, Ramón y Cajal researcher

CONTACT

[email protected]

+34 958246644

Luis Gracia Marco, Senior Lecturer

CONTACT

[email protected]

+34 958244363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).
  • 18-55 years of age at recruitment

Exclusion criteria

  • 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.
  • Having an injury that may affect daily life activities and can be aggravated by exercise.

Treatment and study plan

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.

Primary outcomes

  1. Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)

    Time frame: Baseline and 6 months

    Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³).

  2. Change in Cortical Bone Thickness (pQCT)

    Time frame: Baseline and 6 months

    Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images.

  3. Change in Periosteal and Endocortical Circumference (pQCT)

    Time frame: Baseline and 6 months

    Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm)

  4. Change in Cross-Sectional Moment of Inertia-CSMI (pQCT)

    Time frame: Baseline and 6 months

    CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).

  5. Change in Bone strehgth indices (pQCT)

    Time frame: Baseline and 6 months

    Bone strehgth indices at tibia and radius will be obtained from pQCT images

  6. Change in Bone Mineral Content (DXA)

    Time frame: Baseline and 6 months

    BMC will be assessed using DXA at whole-body and regional sites (g)

  7. Change in Areal Bone Mineral Density (DXA)

    Time frame: Baseline and 6 months

    Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²)

  8. Change in Cross-Sectional Area (DXA-HSA)

    Time frame: Baseline and 6 months

    Derived from hip structural analysis (mm²).

  9. Change in Section Modulus (DXA-HSA)

    Time frame: Baseline and 6 months

    Indicates bone strength; calculated from HSA (mm³).

  10. Change in Cross-Sectional Moment of Inertia (DXA-HSA)

    Time frame: Baseline and 6 months

    Assesses resistance to bending forces (mm⁴).

  11. Change in Trabecular Bone Score (TBS)

    Time frame: Baseline and 6 months

    Lumbar spine texture will be assessed using TBS (TBS index).

  12. Change in Serum Lipid Profile

    Time frame: Baseline and 6 months

    Cholesterol, triglycerides, HDL, LDL levels (mg/dL).

  13. Change in Total bilirubin

    Time frame: Baseline and 6 months

    mg/dL

  14. Change in Calcium

    Time frame: Baseline and 6 months

    mg/dL

  15. Change in Creatinine

    Time frame: Baseline and 6 months

    mg/dL

  16. Change in Phosphorus

    Time frame: Baseline and 6 months

    mg/dL

  17. Change in Glucose

    Time frame: Baseline and 6 months

    mg/dL

  18. Change in Magnesium

    Time frame: Baseline and 6 months

    mg/dL

  19. Change in Uric acid

    Time frame: Baseline and 6 months

    mg/dL

  20. Change in ALT/GPT

    Time frame: Baseline and 6 months

    U/L

  21. Change in Na/K/Cl

    Time frame: Baseline and 6 months

    mEq/L

  22. Change in Albumin

    Time frame: Baseline and 6 months

    g/dL

  23. Change in Total protein

    Time frame: Baseline and 6 months

    g/dL

  24. Change in Serum 25(OH) Vitamin D

    Time frame: Baseline and 6 months

    ng/mL

  25. Change in Alkaline phosphatase

    Time frame: Baseline and 6 months

    U/L

  26. Change in Bone specific alkaline phosphatase

    Time frame: Baseline and 6 months

    ng/mL

  27. Change in Glycosylated hemoglobin

    Time frame: Baseline and 6 months

    mmol/mol

  28. Change in Parathyrin

    Time frame: Baseline and 6 months

    pg/mL

  29. Change in Thyrotropin

    Time frame: Baseline and 6 months

    µUI/mL

  30. Change in Gamma-glutamyl transferase

    Time frame: Baseline and 6 months

    U/L

  31. Change in β-CTX (Serum)

    Time frame: Baseline and 6 months

    Marker of bone resorption (ng/mL)

  32. Change in PINP (Serum)

    Time frame: Baseline and 6 months

    Marker of bone formation (ng/mL)

  33. Change in Irisin (Serum)

    Time frame: Baseline and 6 months

    ng/mL

  34. Change in Sclerostin (Serum)

    Time frame: Baseline and 6 months

    ng/mL

Secondary outcomes

  1. Change in Body Mass

    Time frame: Baseline and 6 months

    Measured with electronic scale (kg).

  2. Change in Height

    Time frame: Baseline and 6 months

    Measured with stadiometer (cm).

  3. Change in Body Mass Index (BMI)

    Time frame: Baseline and 6 months

    Calculated as kg/m².

  4. Change in Blood Pressure

    Time frame: Baseline and 6 months

    Systolic and diastolic pressure measured in mmHg.

  5. Change in body circumferences

    Time frame: Baseline and 6 months

    Waist, hip and neck circumferences measured in cm.

  6. Change in Lean Soft Tissue Mass (DXA)

    Time frame: Baseline and 6 months

    Assessed at whole-body using DXA (g).

  7. Change in Fat Mass (DXA)

    Time frame: Baseline and 6 months

    Assessed at whole-body using DXA (kg).

  8. Change in Body Fat Percentage (DXA)

    Time frame: Baseline and 6 months

    Assessed at whole-body using DXA (%).

  9. Change in 6-Minute Walk Test

    Time frame: Baseline and 6 months

    Distance walked in 6 minutes (meters).

  10. Change in Squat Jump Test

    Time frame: Baseline and 6 months

    Height achieved in the test (cm).

  11. Change in Handgrip Strength Test

    Time frame: Baseline and 6 months

    Maximal grip force (kg).

  12. Change in Standing Long Jump Test

    Time frame: Baseline and 6 months

    Distance achieved in the test (cm).

  13. Change in 5 Times Sit-to-Stand Test

    Time frame: Baseline and 6 months

    Time to complete 5 repetitions (seconds)

  14. Change in 4-m Gait Speed Test

    Time frame: Baseline and 6 months

    Time to walk 4 meters (seconds)

  15. Change in Self-Reported Fitness (IFIS)

    Time frame: Baseline and 6 months

    Perceived fitness using IFIS questionnaire.

  16. Change in Sarcopenia Classification (EWGSOP2)

    Time frame: Baseline and 6 months

    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).

  17. Change in Frailty Status

    Time frame: Baseline and 6 months

    Frailty will be assessed using five criteria: low muscle mass, fatigue, low physical activity, slowness, and weakness. Categorical (frail/non-frail).

  18. Change in Physical Activity and Sedentarism (Accelerometer)

    Time frame: Baseline and 6 months

    Measured over 7 consecutive days using ActiGraph (counts per minute).

  19. Change in Self-Reported Physical Activity (IPAQ)

    Time frame: Baseline and 6 months

    Activity levels using the IPAQ (MET-min/week)

  20. Change in Bone-Specific Physical Activity (BPAQ)

    Time frame: Baseline and 6 months

    Scored from the BPAQ questionnaire (BPAQ score)

  21. Change in Calcium Intake

    Time frame: Baseline and 6 months

    Estimated using validated short calcium questionnaire (mg/day).

  22. Change in Vitamin D Intake

    Time frame: Baseline and 6 months

    Estimated from dietary questionnaire (IU/day).

  23. Change in Mediterranean Diet Adherence

    Time frame: Baseline and 6 months

    Calculated from validated adherence questionnaire (Score 0-14)

  24. Change in Quality of Life

    Time frame: Baseline and 6 months

    HRQoL from the SF-36 questionnaire (0-100 scale).

  25. Change in Anxiety and Depression (HADS)

    Time frame: Baseline and 6 months

    Anxiety and depression score from HADS (Score 0-21)

  26. Change in Self-Esteem (Rosenberg Scale)

    Time frame: Baseline and 6 months

    Assessed using Rosenberg Self-Esteem Scale (Score 0-30)

  27. Change in Perceived Stress (PSS)

    Time frame: Baseline and 6 months

    Assessed via Perceived Stress Scale (Score 0-40).

Other outcomes

  1. Change in objective strength

    Time frame: Baseline and 6 months

    Objective strength will be measured with a functional electromechanical dynamometer-DynaSystem (kg)

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Ubago Guisado, Ramón y Cajal researcher

CONTACT

[email protected]

+34 958246644

Luis Gracia Marco, Senior Lecturer

CONTACT

[email protected]

+34 958244363

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Hospital Materno-Infantil Torrecárdenas de Almería
  • Hospital Universitario Reina Sofia de Cordoba
  • Loyola University
  • University Hospital Virgen de las Nieves
  • University of Thessaly

Registry information

Official study title

3D-BONE: Virtual Exercise Training and Its Impact on Cortical and Trabecular Bone Compartments in Adult Survivors of Childhood Cancer: a Peripheral Quantitative Computed Tomography (pQCT) Study

Acronym: 3D-BONE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 15, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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