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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversidad de Granada

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).

18-55 years of age at recruitment

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Change in Body Mass

Measured with electronic scale (kg).

Time frame
Baseline and 6 months
2

Change in Height

Measured with stadiometer (cm).

Time frame
Baseline and 6 months
3

Change in Body Mass Index (BMI)

Calculated as kg/m².

Time frame
Baseline and 6 months
4

Change in Blood Pressure

Systolic and diastolic pressure measured in mmHg.

Time frame
Baseline and 6 months

Other outcomes

1

Change in objective strength

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

Time frame
Baseline and 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Granada

Lead sponsor

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

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