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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Progressive resistance training plus impact loading
  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 i

Первичные конечные точки

• Change in Cortical and Trabecular Volumetric Bone Mineral Density (pQCT) [Срок оценки: Baseline and 6 months]
• Change in Cortical Bone Thickness (pQCT) [Срок оценки: Baseline and 6 months]
• Change in Periosteal and Endocortical Circumference (pQCT) [Срок оценки: Baseline and 6 months]
• Change in Cross-Sectional Moment of Inertia-CSMI (pQCT) [Срок оценки: Baseline and 6 months]
• Change in Bone strehgth indices (pQCT) [Срок оценки: Baseline and 6 months]
• Change in Bone Mineral Content (DXA) [Срок оценки: Baseline and 6 months]
• Change in Areal Bone Mineral Density (DXA) [Срок оценки: Baseline and 6 months]
• Change in Cross-Sectional Area (DXA-HSA) [Срок оценки: Baseline and 6 months]
• Change in Section Modulus (DXA-HSA) [Срок оценки: Baseline and 6 months]
• Change in Cross-Sectional Moment of Inertia (DXA-HSA) [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (12)

• Change in Body Mass [Срок оценки: Baseline and 6 months]
• Change in Height [Срок оценки: Baseline and 6 months]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline and 6 months]
• Change in Blood Pressure [Срок оценки: Baseline and 6 months]
• Change in body circumferences [Срок оценки: Baseline and 6 months]
• Change in Lean Soft Tissue Mass (DXA) [Срок оценки: Baseline and 6 months]
• Change in Fat Mass (DXA) [Срок оценки: Baseline and 6 months]
• Change in Body Fat Percentage (DXA) [Срок оценки: Baseline and 6 months]
• Change in 6-Minute Walk Test [Срок оценки: Baseline and 6 months]
• Change in Squat Jump Test [Срок оценки: Baseline and 6 months]
• Change in Handgrip Strength Test [Срок оценки: Baseline and 6 months]
• Change in Standing Long Jump Test [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• Prior diagnosis of pediatric cancer and history of receiving treatment (radiation therapy and/or chemotherapy).
• 18-55 years of age at recruitment

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Sport and Health University Research Institute (iMUDS), Technological Health Park, Univers — Granada

Идентификаторы

NCT: NCT07022262 · Universidad de Granada · PID2023-150311OB-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗