Paediatric cancer survivors at risk of endocrine dysfunction Cancer
Conditions
Interventions
iBoneFIT is a multicentre randomized controlled trial. Participants will be allocated into two groups: an intervention group (a 9-month exercise intervention) and a control group (no exercise program
updated 11/08/2020: no exercise intervention). Specific dietary advice regarding calcium and vitamin D will be given to both groups. Simple randomization will be applied using an online tool.
Interve
in stage 2 (3 months), participants will perform squat jumps
in stage 3 (4 months), participants will perform countermovement jumps.
Furthermore, five behavior change techniques were used to increase participants’ engagement (i.e. action planning and goal set
Sponsors
University of Granada
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Paediatric cancer survivors 6 to 18 years old 2. =1 year from diagnosis 3. Have been exposed to radiotherapy or chemotherapy 4. Not currently receiving treatment for cancer
Exclusion criteria
Exclusion criteria: 1. Simultaneous participation in another study 2. Previous diagnosed anorexia nervosa/bulimia; known pregnancy, alcohol or drug abuse 3. Children requiring chronic oral glucocorticoid therapy or pharmacologic agents for reduced BMD other than calcium or vitamin D 4. Presence of an injury (before inclusion) that may affect daily life activities and can be aggravated by exercise 5. Have a lower limb prosthesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 20/06/2022: 1. Bone mineral density measured using Dual-energy X-ray Absorptiometry (DXA) at baseline and post-intervention 2. Bone architecture and geometry measured using specific software for Hip Structural Analysis at baseline and post-intervention 3. Spine Trabecular Bone Score measured using the software iNsight at baseline and post-intervention 4. Volumetric bone parameters measured using the software 3D-SHAPER at baseline and post-intervention Previous primary outcome measures from 11/08/2020 to 20/06/2022: 1. Bone mineral density measured using Dual-energy X-ray Absorptiometry (DXA) at baseline, post-intervention and follow-up (4 months post-intervention) 2. Bone architecture and geometry measured using specific software for Hip Structural Analysis at baseline, post-intervention and follow-up (4 months post-intervention) 3. Spine Trabecular Bone Score measured using the software iNsight at baseline, post-intervention and follow-up (4 months post-intervention) 4. Volumetric bone parameters measured using the software 3D-SHAPER at baseline, post-intervention and follow-up (4 months post-intervention) Previous primary outcome measures: 1. Bone mineral density measured using Dual-energy X-ray Absorptiometry (DXA) at baseline, post-intervention and follow-up (4 months post-intervention) 2. Bone architecture and geometry using specific software for Hip Structural Analysis Trabecular Bone Score at baseline, post-intervention and follow-up (4 months post-intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/06/2022: 1. Anthropometric measurements measured using an electronic scale for body mass and a precision stadiometer for body height (body mass index is also calculated). Body composition measured using DXA and a bioimpedance scale. Additionally, somatic maturation measured using the prediction of years from peak height velocity using validated algorithms for children. All of these parameters are assessed at baseline and post-intervention. 2. Physical fitness measured using the ALPHA fitness test battery at baseline and post-intervention. In addition, perceived physical fitness measured by the International Fitness Scale 3. Physical activity and sedentarism measured using tri-axial accelerometers at baseline and post-intervention. Furthermore, these variables are measured using the Youth Activity Profile questionnaire. Additionally, the influence of previous physical activities on bone is measured using the bone-specific physical activity questionnaire. 4. Calcium intake measured using a food-frequency questionnaire at baseline and post-intervention. Vitamin D status measured using the vitamin D questionnaire at baseline and post-intervention 5. Biochemical markers measured using venous blood samples between 8:00 and 10:00 after an overnight fast at baseline and post-intervention 6. Psychological distress measured using State-Trait Anxiety Inventory for Children (STAIC-T), Children Depression Inventory (CDI) and Positive Affect Schedule for children (PANAS-C) at baseline and post-intervention 7. Well-being measured using Subjective Happiness Scale (SHS), Life Orientation Test-Revised (LOT-R) and Positive Affect Schedule for children (PANAS-C) at baseline and post-intervention 8. Quality of life measured using the Paediatric Quality of Life Inventory (PedsQLTM 4.0 Generic Core Scales) at baseline and post-intervention Previous secondary outcome measures from 11/08/2020 to 20/06/2022: 1. Anthropometric measurements measured | — |
Countries
Spain
Contacts
Public ContactLuis Andrés Gracia Marco
Outcome results
None listed