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

NCT07022262 | Not Yet Recruiting

• 2 other identifiers: Universidad de GranadaPID2023-150311OB-I00
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Survivors

Keywords

cancer survivors; childhood cancer; exercise; bone health; physical fitness; sarcopenia; physiological frailty; mental health; health-related quality of life; pQCT

Outcome Measures

Primary Outcomes (34)

• 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

• 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

Secondary Outcomes (27)

• Change in Body Mass

  Baseline and 6 months

• Change in Height

  Baseline and 6 months

• Change in Body Mass Index (BMI)

  Baseline and 6 months

• Change in Blood Pressure

  Baseline and 6 months

• Change in body circumferences

  Baseline and 6 months

Other Outcomes (1)

• Change in objective strength

  Baseline and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

6-months of live and online progressive resistance training plus impact loading + dietary counselling on calcium and vitamin D.

Behavioral: Progressive resistance training plus impact loading

Control group

NO INTERVENTION

Dietary counselling on calcium and vitamin D.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• 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

Study Sites (1)

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

Granada, Andalusia, 18007, Spain

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity; Sarcopenia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Personal Satisfaction

Central Study Contacts

Esther Ubago Guisado, Ramón y Cajal researcher

CONTACT

+34 958246644; estherug@ugr.es

Luis Gracia Marco, Senior Lecturer

CONTACT

+34 958244363; lgracia@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)