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

N/ANot Yet RecruitingNCT07022262

Universidad de Granada116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Conditions

Cancer Survivors

Interventions

Progressive resistance training plus impact loadingBEHAVIORAL

The structure of the exercise sessions will be: 1) warm up; 2) progressive resistance training plus impact loading; 3) cool down. Briefly, the warm-ups will be based on RAMP methodology (i.e., raise, activate, mobilise and potentiate) in order to maximize middle-term performance of the main exercises. Exercises focused on the brace, squat, lunge or jump patterns will be included in the first part of the session. The main part of the session will consist of 9 sets of 10-12 jumps, 9 sets of 10-12 repetitions of lower body resistance exercise and 3 sets of 10-12 repetitions of upper resistance exercise. Each set will be performed with approximately 15-30 seconds of rest for jumps and 2-3 minutes of rest for resistance exercises. Finally, participants will perform a cool down including guided static stretching and relaxing exercises.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Granada, Andalusia, Spain

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 6 months

Change in Cortical Bone Thickness (pQCT)

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

Time frame: 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)

Time frame: 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).

Time frame: Baseline and 6 months

Change in Muscle Area (pQCT)

Muscle area at tibia and radius will be obtained from pQCT images (cm²)

Time frame: Baseline and 6 months

Change in Bone Mineral Content (DXA)

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

Time frame: 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)

Time frame: Baseline and 6 months

Change in Cross-Sectional Area (DXA-HSA)

Derived from hip structural analysis (mm²).

Time frame: Baseline and 6 months

Change in Section Modulus (DXA-HSA)

Indicates bone strength; calculated from HSA (mm³).

Time frame: Baseline and 6 months

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

Assesses resistance to bending forces (mm⁴).

Time frame: Baseline and 6 months

Change in Trabecular Bone Score (TBS)

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

Time frame: Baseline and 6 months

Change in Serum Lipid Profile

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

Time frame: Baseline and 6 months

Change in Total bilirubin

mg/dL

Time frame: Baseline and 6 months

Change in Calcium

mg/dL

Time frame: Baseline and 6 months

Change in Creatinine

mg/dL

Time frame: Baseline and 6 months

Change in Phosphorus

mg/dL

Time frame: Baseline and 6 months

Change in Glucose

mg/dL

Time frame: Baseline and 6 months

Change in Magnesium

mg/dL

Time frame: Baseline and 6 months

Change in Uric acid

mg/dL

Time frame: Baseline and 6 months

Change in ALT/GPT

U/L

Time frame: Baseline and 6 months

Change in Na/K/Cl

mEq/L

Time frame: Baseline and 6 months

Change in Albumin

g/dL

Time frame: Baseline and 6 months

Change in Total protein

g/dL

Time frame: Baseline and 6 months

Change in Serum 25(OH) Vitamin D

ng/mL

Time frame: Baseline and 6 months

Change in Alkaline phosphatase

U/L

Time frame: Baseline and 6 months

Change in Bone specific alkaline phosphatase

ng/mL

Time frame: Baseline and 6 months

Change in Glycosylated hemoglobin

mmol/mol

Time frame: Baseline and 6 months

Change in Parathyrin

pg/mL

Time frame: Baseline and 6 months

Change in Thyrotropin

µUI/mL

Time frame: Baseline and 6 months

Change in Gamma-glutamyl transferase

U/L

Time frame: Baseline and 6 months

Change in β-CTX (Serum)

Marker of bone resorption (ng/mL)

Time frame: Baseline and 6 months

Change in PINP (Serum)

Marker of bone formation (ng/mL)

Time frame: Baseline and 6 months

Change in Irisin (Serum)

ng/mL

Time frame: Baseline and 6 months

Change in Sclerostin (Serum)

ng/mL

Time frame: Baseline and 6 months

Secondary Outcomes

Change in Body Mass

Measured with electronic scale (kg).

Time frame: Baseline and 6 months

Change in Height

Measured with stadiometer (cm).

Time frame: Baseline and 6 months

Change in Body Mass Index (BMI)

Calculated as kg/m².

Time frame: Baseline and 6 months

Change in Blood Pressure

Systolic and diastolic pressure measured in mmHg.

Time frame: Baseline and 6 months

Change in body circumferences

Waist, hip and neck circumferences measured in cm.

Time frame: Baseline and 6 months

Change in Lean Soft Tissue Mass (DXA)

Assessed at whole-body using DXA (g).

Time frame: Baseline and 6 months

Change in Fat Mass (DXA)

Assessed at whole-body using DXA (kg).

Time frame: Baseline and 6 months

Change in Body Fat Percentage (DXA)

Assessed at whole-body using DXA (%).

Time frame: Baseline and 6 months

Change in 6-Minute Walk Test

Distance walked in 6 minutes (meters).

Time frame: Baseline and 6 months

Change in Squat Jump Test

Height achieved in the test (cm).

Time frame: Baseline and 6 months

Central 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change in Handgrip Strength Test

Maximal grip force (kg).

Time frame: Baseline and 6 months

Change in Standing Long Jump Test

Distance achieved in the test (cm).

Time frame: Baseline and 6 months

Change in 5 Times Sit-to-Stand Test

Time to complete 5 repetitions (seconds)

Time frame: Baseline and 6 months

Change in 4-m Gait Speed Test

Time to walk 4 meters (seconds)

Time frame: Baseline and 6 months

Change in Self-Reported Fitness (IFIS)

Perceived fitness using IFIS questionnaire.

Time frame: Baseline and 6 months

Change in Sarcopenia Classification (EWGSOP2)

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).

Time frame: Baseline and 6 months

Change in Frailty Status

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

Time frame: Baseline and 6 months

Change in Physical Activity and Sedentarism (Accelerometer)

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

Time frame: Baseline and 6 months

Change in Self-Reported Physical Activity (IPAQ)

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

Time frame: Baseline and 6 months

Change in Bone-Specific Physical Activity (BPAQ)

Scored from the BPAQ questionnaire (BPAQ score)

Time frame: Baseline and 6 months

Change in Calcium Intake

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

Time frame: Baseline and 6 months

Change in Vitamin D Intake

Estimated from dietary questionnaire (IU/day).

Time frame: Baseline and 6 months

Change in Mediterranean Diet Adherence

Calculated from validated adherence questionnaire (Score 0-14)

Time frame: Baseline and 6 months

Change in Quality of Life

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

Time frame: Baseline and 6 months

Change in Anxiety and Depression (HADS)

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

Time frame: Baseline and 6 months

Change in Self-Esteem (Rosenberg Scale)

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

Time frame: Baseline and 6 months

Change in Perceived Stress (PSS)

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

Time frame: Baseline and 6 months