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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change in Serum Lipid Profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).
- •18-55 years of age at recruitment
排除标准
- •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.
研究组 & 干预措施
Intervention group
6-months of live and online progressive resistance training plus impact loading + dietary counselling on calcium and vitamin D.
干预措施: Progressive resistance training plus impact loading (Behavioral)
Control group
Dietary counselling on calcium and vitamin D.
结局指标
主要结局
Change in Serum Lipid Profile
时间窗: Baseline and 6 months
Cholesterol, triglycerides, HDL, LDL levels (mg/dL).
Change in Total bilirubin
时间窗: Baseline and 6 months
mg/dL
Change in Calcium
时间窗: Baseline and 6 months
mg/dL
Change in Creatinine
时间窗: Baseline and 6 months
mg/dL
Change in Phosphorus
时间窗: Baseline and 6 months
mg/dL
Change in Glucose
时间窗: Baseline and 6 months
mg/dL
Change in Magnesium
时间窗: Baseline and 6 months
mg/dL
Change in Uric acid
时间窗: Baseline and 6 months
mg/dL
Change in ALT/GPT
时间窗: Baseline and 6 months
U/L
Change in Na/K/Cl
时间窗: Baseline and 6 months
mEq/L
Change in β-CTX (Serum)
时间窗: Baseline and 6 months
Marker of bone resorption (ng/mL)
Change in PINP (Serum)
时间窗: Baseline and 6 months
Marker of bone formation (ng/mL)
Change in Cross-Sectional Moment of Inertia-CSMI (pQCT)
时间窗: Baseline and 6 months
CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).
Change in Bone Mineral Content (DXA)
时间窗: Baseline and 6 months
BMC will be assessed using DXA at whole-body and regional sites (g)
Change in Areal Bone Mineral Density (DXA)
时间窗: 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)
时间窗: Baseline and 6 months
Derived from hip structural analysis (mm²).
Change in Section Modulus (DXA-HSA)
时间窗: Baseline and 6 months
Indicates bone strength; calculated from HSA (mm³).
Change in Cross-Sectional Moment of Inertia (DXA-HSA)
时间窗: Baseline and 6 months
Assesses resistance to bending forces (mm⁴).
Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)
时间窗: 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)
时间窗: Baseline and 6 months
Cortical bone thickness at tibia and radius (mm) will be derived from pQCT images.
Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT)
时间窗: Baseline and 6 months
Cortical and trabecular BMD will be measured at tibia and radius using pQCT (mg/cm³).
Change in Trabecular Bone Score (TBS)
时间窗: Baseline and 6 months
Lumbar spine texture will be assessed using TBS (TBS index).
Change in Periosteal and Endocortical Circumference (pQCT)
时间窗: Baseline and 6 months
Periosteal and endocortical circumference at tibia and radius will be measured via pQCT (mm)
Change in Cortical Bone Thickness (pQCT)
时间窗: 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)
时间窗: 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)
时间窗: Baseline and 6 months
CSMI at tibia and radius will be calculated to assess structural bone strength (mm⁴).
Change in Muscle Area (pQCT)
时间窗: Baseline and 6 months
Muscle area at tibia and radius will be obtained from pQCT images (cm²)
Change in Areal Bone Mineral Density (DXA)
时间窗: Baseline and 6 months
Areal BMD will be measured with DXA at whole-body and regional sites (g/cm²)
Change in Calcium
时间窗: Baseline and 6 months
mg/dL
Change in Bone strehgth indices (pQCT)
时间窗: Baseline and 6 months
Bone strehgth indices at tibia and radius will be obtained from pQCT images
Change in Bone Mineral Content (DXA)
时间窗: Baseline and 6 months
BMC will be assessed using DXA at whole-body and regional sites (g)
Change in Cross-Sectional Area (DXA-HSA)
时间窗: Baseline and 6 months
Derived from hip structural analysis (mm²).
Change in Section Modulus (DXA-HSA)
时间窗: Baseline and 6 months
Indicates bone strength; calculated from HSA (mm³).
Change in Trabecular Bone Score (TBS)
时间窗: Baseline and 6 months
Lumbar spine texture will be assessed using TBS (TBS index).
Change in Serum Lipid Profile
时间窗: Baseline and 6 months
Cholesterol, triglycerides, HDL, LDL levels (mg/dL).
Change in Total bilirubin
时间窗: Baseline and 6 months
mg/dL
Change in Glucose
时间窗: Baseline and 6 months
mg/dL
Change in Magnesium
时间窗: Baseline and 6 months
mg/dL
Change in Na/K/Cl
时间窗: Baseline and 6 months
mEq/L
Change in Cross-Sectional Moment of Inertia (DXA-HSA)
时间窗: Baseline and 6 months
Assesses resistance to bending forces (mm⁴).
Change in ALT/GPT
时间窗: Baseline and 6 months
U/L
Change in Creatinine
时间窗: Baseline and 6 months
mg/dL
Change in Phosphorus
时间窗: Baseline and 6 months
mg/dL
Change in Uric acid
时间窗: Baseline and 6 months
mg/dL
Change in Albumin
时间窗: Baseline and 6 months
g/dL
Change in Total protein
时间窗: Baseline and 6 months
g/dL
Change in Serum 25(OH) Vitamin D
时间窗: Baseline and 6 months
ng/mL
Change in Alkaline phosphatase
时间窗: Baseline and 6 months
U/L
Change in Bone specific alkaline phosphatase
时间窗: Baseline and 6 months
ng/mL
Change in Glycosylated hemoglobin
时间窗: Baseline and 6 months
mmol/mol
Change in Parathyrin
时间窗: Baseline and 6 months
pg/mL
Change in Thyrotropin
时间窗: Baseline and 6 months
µUI/mL
Change in Gamma-glutamyl transferase
时间窗: Baseline and 6 months
U/L
Change in β-CTX (Serum)
时间窗: Baseline and 6 months
Marker of bone resorption (ng/mL)
Change in PINP (Serum)
时间窗: Baseline and 6 months
Marker of bone formation (ng/mL)
Change in Irisin (Serum)
时间窗: Baseline and 6 months
ng/mL
Change in Sclerostin (Serum)
时间窗: Baseline and 6 months
ng/mL
次要结局
- Change in Mediterranean Diet Adherence(Baseline and 6 months)
- Change in Quality of Life(Baseline and 6 months)
- Change in Anxiety and Depression (HADS)(Baseline and 6 months)
- Change in Self-Esteem (Rosenberg Scale)(Baseline and 6 months)
- Change in Perceived Stress (PSS)(Baseline and 6 months)
- 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)
- Change in Lean Soft Tissue Mass (DXA)(Baseline and 6 months)
- Change in Fat Mass (DXA)(Baseline and 6 months)
- Change in Body Fat Percentage (DXA)(Baseline and 6 months)
- Change in 6-Minute Walk Test(Baseline and 6 months)
- Change in Handgrip Strength Test(Baseline and 6 months)
- Change in Standing Long Jump Test(Baseline and 6 months)
- Change in 5 Times Sit-to-Stand Test(Baseline and 6 months)
- Change in 4-m Gait Speed Test(Baseline and 6 months)
- Change in Self-Reported Fitness (IFIS)(Baseline and 6 months)
- Change in Vitamin D Intake(Baseline and 6 months)
- Change in Sarcopenia Classification (EWGSOP2)(Baseline and 6 months)
- Change in Frailty Status(Baseline and 6 months)
- Change in Physical Activity and Sedentarism (Accelerometer)(Baseline and 6 months)
- Change in Self-Reported Physical Activity (IPAQ)(Baseline and 6 months)
- Change in Bone-Specific Physical Activity (BPAQ)(Baseline and 6 months)
- Change in Calcium Intake(Baseline and 6 months)
- Change in Height(Baseline and 6 months)
- Change in 6-Minute Walk Test(Baseline and 6 months)
- Change in Lean Soft Tissue Mass (DXA)(Baseline and 6 months)
- Change in Standing Long Jump Test(Baseline and 6 months)
- Change in Self-Reported Physical Activity (IPAQ)(Baseline and 6 months)
- Change in Bone-Specific Physical Activity (BPAQ)(Baseline and 6 months)
- Change in Calcium Intake(Baseline and 6 months)
- Change in Self-Esteem (Rosenberg Scale)(Baseline and 6 months)
- Change in Body Mass Index (BMI)(Baseline and 6 months)
- Change in Squat Jump Test(Baseline and 6 months)
- Change in Handgrip Strength Test(Baseline and 6 months)
- Change in 5 Times Sit-to-Stand Test(Baseline and 6 months)
- Change in 4-m Gait Speed Test(Baseline and 6 months)
- Change in Body Mass(Baseline and 6 months)
- Change in Blood Pressure(Baseline and 6 months)
- Change in body circumferences(Baseline and 6 months)
- Change in Body Fat Percentage (DXA)(Baseline and 6 months)
- Change in Fat Mass (DXA)(Baseline and 6 months)
- Change in Frailty Status(Baseline and 6 months)
- Change in Vitamin D Intake(Baseline and 6 months)
- Change in Self-Reported Fitness (IFIS)(Baseline and 6 months)
- Change in Sarcopenia Classification (EWGSOP2)(Baseline and 6 months)
- Change in Mediterranean Diet Adherence(Baseline and 6 months)
- Change in Quality of Life(Baseline and 6 months)
- Change in Physical Activity and Sedentarism (Accelerometer)(Baseline and 6 months)
- Change in Anxiety and Depression (HADS)(Baseline and 6 months)
- Change in Perceived Stress (PSS)(Baseline and 6 months)
研究者
Esther Ubago Guisado
Principal Investigator
Universidad de Granada