Virtual Exercise Training and Its Impact on Bone Compartments in Adult Survivors of Childhood Cancer (3D-BONE)

University of Granada (UGR)

Status

Not yet enrolling

Conditions

Cancer Survivors

Treatments

Behavioral: Progressive resistance training plus impact loading

Study type

Interventional

Funder types

Other

Identifiers

NCT07022262

Universidad de Granada

PID2023-150311OB-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

116 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.