Clinical trial NCT07022262: Virtual Exercise Training and Its Impact on Bone Compartments in Adult Survivors of Childhood Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: cancer survivors
childhood cancer
exercise
bone health
physical fitness
sarcopenia
physiological frailty
mental health
health-related quality of life
pQCT
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Loyola University
name: University of Thessaly
name: Hospital Materno-Infantil Torrecárdenas de Almería
name: Hospital Universitario Reina Sofia de Cordoba
name: University Hospital Virgen de las Nieves
First posted: 2025-06-15
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)
timeFrame: Baseline and 6 months
measure: Change in Cortical Bone Thickness (pQCT)
timeFrame: Baseline and 6 months
measure: Change in Periosteal and Endocortical Circumference (pQCT)
timeFrame: Baseline and 6 months
measure: Change in Cross-Sectional Moment of Inertia-CSMI (pQCT)
timeFrame: Baseline and 6 months
measure: Change in Muscle Area (pQCT)
timeFrame: Baseline and 6 months
measure: Change in Bone Mineral Content (DXA)
timeFrame: Baseline and 6 months
measure: Change in Areal Bone Mineral Density (DXA)
timeFrame: Baseline and 6 months
measure: Change in Cross-Sectional Area (DXA-HSA)
timeFrame: Baseline and 6 months
measure: Change in Section Modulus (DXA-HSA)
timeFrame: Baseline and 6 months
measure: Change in Cross-Sectional Moment of Inertia (DXA-HSA)
timeFrame: Baseline and 6 months
measure: Change in Trabecular Bone Score (TBS)
timeFrame: Baseline and 6 months
measure: Change in Serum Lipid Profile
timeFrame: Baseline and 6 months
measure: Change in Total bilirubin
timeFrame: Baseline and 6 months
measure: Change in Calcium
timeFrame: Baseline and 6 months
measure: Change in Creatinine
timeFrame: Baseline and 6 months
measure: Change in Phosphorus
timeFrame: Baseline and 6 months
measure: Change in Glucose
timeFrame: Baseline and 6 months
measure: Change in Magnesium
timeFrame: Baseline and 6 months
measure: Change in Uric acid
timeFrame: Baseline and 6 months
measure: Change in ALT/GPT
timeFrame: Baseline and 6 months
measure: Change in Na/K/Cl
timeFrame: Baseline and 6 months
measure: Change in Albumin
timeFrame: Baseline and 6 months
measure: Change in Total protein
timeFrame: Baseline and 6 months
measure: Change in Serum 25(OH) Vitamin D
timeFrame: Baseline and 6 months
measure: Change in Alkaline phosphatase
timeFrame: Baseline and 6 months
measure: Change in Bone specific alkaline phosphatase
timeFrame: Baseline and 6 months
measure: Change in Glycosylated hemoglobin
timeFrame: Baseline and 6 months
measure: Change in Parathyrin
timeFrame: Baseline and 6 months
measure: Change in Thyrotropin
timeFrame: Baseline and 6 months
measure: Change in Gamma-glutamyl transferase
timeFrame: Baseline and 6 months
measure: Change in β-CTX (Serum)
timeFrame: Baseline and 6 months
measure: Change in PINP (Serum)
timeFrame: Baseline and 6 months
measure: Change in Irisin (Serum)
timeFrame: Baseline and 6 months
measure: Change in Sclerostin (Serum)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Body Mass
timeFrame: Baseline and 6 months
measure: Change in Height
timeFrame: Baseline and 6 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 6 months
measure: Change in Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in body circumferences
timeFrame: Baseline and 6 months
measure: Change in Lean Soft Tissue Mass (DXA)
timeFrame: Baseline and 6 months
measure: Change in Fat Mass (DXA)
timeFrame: Baseline and 6 months
measure: Change in Body Fat Percentage (DXA)
timeFrame: Baseline and 6 months
measure: Change in 6-Minute Walk Test
timeFrame: Baseline and 6 months
measure: Change in 2-km Walk Test
timeFrame: Baseline and 6 months
measure: Change in Handgrip Strength Test
timeFrame: Baseline and 6 months
measure: Change in Standing Long Jump Test
timeFrame: Baseline and 6 months
measure: Change in 5 Times Sit-to-Stand Test
timeFrame: Baseline and 6 months
measure: Change in 4-m Gait Speed Test
timeFrame: Baseline and 6 months
measure: Change in Self-Reported Fitness (IFIS)
timeFrame: Baseline and 6 months
measure: Change in Sarcopenia Classification (EWGSOP2)
timeFrame: Baseline and 6 months
measure: Change in Frailty Status
timeFrame: Baseline and 6 months
measure: Change in Physical Activity and Sedentarism (Accelerometer)
timeFrame: Baseline and 6 months
measure: Change in Self-Reported Physical Activity (IPAQ)
timeFrame: Baseline and 6 months
measure: Change in Bone-Specific Physical Activity (BPAQ)
timeFrame: Baseline and 6 months
measure: Change in Calcium Intake
timeFrame: Baseline and 6 months
measure: Change in Vitamin D Intake
timeFrame: Baseline and 6 months
measure: Change in Mediterranean Diet Adherence
timeFrame: Baseline and 6 months
measure: Change in Quality of Life
timeFrame: Baseline and 6 months
measure: Change in Anxiety and Depression (HADS)
timeFrame: Baseline and 6 months
measure: Change in Self-Esteem (Rosenberg Scale)
timeFrame: Baseline and 6 months
measure: Change in Perceived Stress (PSS)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada
state: Andalucía
Study officials:
References: