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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Progressive resistance training plus impact loading

Intervention Type BEHAVIORAL

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.

Control group

Dietary counselling on calcium and vitamin D.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Progressive resistance training plus impact loading

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No