Plain English Summary
Background and study aims
Despite a 13% increase in childhood cancer incidence over the last 40 years, the 5-year survival rate has now been set up at 80%. However, curing cancer has important consequences. One of the most common issues in paediatric cancer survivors is a reduction of the bone mineral density. Recent evidence highlights the survivorship phase (rather than the treatment one) for performing interventions to improve bone health. Exercise can improve bone health in healthy children; however, this effect has not been studied yet in this population.
This intervention will analyse the influence of a 9-month exercise intervention on bone mass in growing paediatric cancer survivors.
Who can participate?
Paediatric cancer survivors 6 to 18-years of age at recruitment, ≥ 1year from diagnosis and not currently receiving treatment for cancer.
What does the study involve?
Participants will be randomly allocated to the intervention or control group. The intervention will involve a combination of strength and jumping activities. Likewise, the intervention will aim to improve muscular fitness before implementing mechanical loading through jumping exercises. This exercise program will be completed at home and delivered through an online platform. The control group will not perform the exercise program, but they will be offered the same program at the end of the intervention. Nutritional and sun exposure counselling will also be given to both groups.
What are the possible benefits and risks of participating?
The main expected benefit of participating in this study is the improvement in bone mass which lowers the risk of having future bone diseases, such as osteoporosis. The risks of participating are similar to those derived of exercise practice.
Where is the study run from?
1. Virgen de las Nieves Hospital (Spain)
2. Reina Sofía Hospital (Spain)
When is the study starting and how long is it expected to run for?
May 2020 to February 2023
Who is funding the study?
1. “la Caixa” Foundation (Spain)
2. Ministry of Science and Innovation (Spain)
Who is the main contact?
Dr Luis Andrés Gracia Marco, lgracia@ugr.es
Study website
Contact information
Type
Public
Contact name
Dr Luis Andrés Gracia Marco
ORCID ID
http://orcid.org/0000-0002-4020-0256
Contact details
Pasaje de la Ciencia 1
Granada
18016
Spain
+34 689 205 924
lgracia@ugr.es
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
LCF/ BO/PR19/11700007
Study information
Scientific title
Effect of an online exercise program on bone health in paediatric cancer survivors
Acronym
iBoneFIT
Study hypothesis
A 9-month plyometric-exercise intervention improves bone health in paediatric cancer survivors
Ethics approval(s)
Approved 10/01/2020, Review Committee for Research Involving Human Subjects of Andalucía (Comite de Etica de Investigación de Cordoba. Avda. Menéndez Pidal s/nº 14004-Córdoba, Spain; no tel. provided; no email provided), ref: 4500
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Paediatric cancer survivors at risk of endocrine dysfunction
Intervention
iBoneFIT is a multicentre randomized controlled trial. Participants will be allocated into two groups: intervention group (a 9-month exercise intervention) and control group (no exercise program for 9 months; 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.
Intervention group: The program will be delivered via an online platform. Nutritional and sun exposure counselling will also be given. The 9-month intervention will involve 3 to 4 days/week of a home-based jumping programme. The jumping programme takes approximately 10 min/day and all activities will be performed on hard surfaces. In brief, the jumping intervention will consist of 3 stages and the volume of each stage will increase progressively. In stage 1 (2 months), participants will perform body mass-based squats; 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 setting, provide instructions and demonstrations of how to perform the behavior, self-monitoring of behavior, provide feedback on performance and information about health consequences). Likewise, a gamification design (i.e. points, rankings and rewards) was included to improve the interest, incentive and purposiveness of this non-game program.
Control group: no exercise program will be delivered. At the end of the intervention, the exercise program will be offered to all participants in the control group.
Educational advice and leaflets about the importance of healthy lifestyles, nutrition and sun exposure will be given to both groups on a monthly basis.
Intervention type
Behavioural
Primary outcome measure
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 outcome measures
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 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, post-intervention and follow-up (4 months post-intervention).
2. Physical fitness measured using the ALPHA fitness test battery at baseline, post-intervention and follow-up (4 months 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, post-intervention and follow-up (4 months 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, post-intervention and follow-up (4 months post-intervention). Vitamin D status measured using the vitamin D questionnaire at baseline, post-intervention and follow-up (4 months post-intervention)
5. Biochemical markers measured using venous blood samples between 8:00 and 10:00 after an overnight fast at baseline, post-intervention and follow-up (4 months 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, post-intervention and follow-up (4 months 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, post-intervention and follow-up (4 months post-intervention)
8. Quality of life measured using the Paediatric Quality of Life Inventory (PedsQLTM 4.0 Generic Core Scales) at baseline, post-intervention and follow-up (4 months post-intervention)
Previous secondary outcome measures:
1. Biochemical markers measured using venous blood samples between 8:00 and 10:00 after an overnight fast at baseline, post-intervention and follow-up (4 months post-intervention)
2. Physical activity measured using tri-axial accelerometers at baseline, post-intervention and follow-up (4 months post-intervention)
3. Physical fitness measured using the ALPHA fitness test battery at baseline, post-intervention and follow-up (4 months post-intervention)
4. 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, post-intervention and follow-up (4 months post-intervention)
5. Well-being measured using Subjective Happiness Scale (SHS), Life Orientation Test-Revised (LOT-R) and Positive Affect Schedule for children (PANAS-C) at baseline, post-intervention and follow-up (4 months post-intervention)
6. Quality of life measured using the Paediatric Quality of Life Inventory (PedsQLTM 4.0 Generic Core Scales) at baseline, post-intervention and follow-up (4 months post-intervention)
Overall study start date
01/05/2019
Overall study end date
01/02/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Paediatric cancer survivors 6 to 18 years old
2. ≥ 1yr from diagnosis
3. Have been exposed to radiotherapy or chemotherapy
4. Not currently receiving treatment for cancer
Participant type(s)
Patient
Age group
Child
Lower age limit
6 Years
Upper age limit
18 Years
Sex
Both
Target number of participants
A minimum of 116 participants (58 per group)
Total final enrolment
116
Participant 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
Recruitment start date
01/09/2020
Recruitment end date
21/03/2022
Locations
Countries of recruitment
Spain
Study participating centre
Virgen de las Nieves Hospital
Ribera del Beiro, s/n
Granada
18014
Spain
Study participating centre
Reina Sofía Hospital
Menendez Pidal, s/n
Córdoba
14004
Spain
Sponsor information
Organisation
University of Granada
Sponsor details
Cuesta del Hospicio s/n
Granada
18071
Spain
+34 958 243 000
informa@ugr.es
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
“la Caixa” Foundation
Alternative name(s)
Caixa Foundation, Fundación Caixa, 'la Caixa', Fundación Bancaria Caixa d'Estalvis i Pensions de Barcelona, Fundación 'la Caixa', Fundação 'la Caixa', Fundación Bancaria Caixa d'Estalvis i Pensions de Barcelona, 'la Caixa'
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Spain
Funder name
Ministerio de Ciencia e Innovación
Alternative name(s)
CienciaGob, Ministerio de Ciencia e Innovación de España, Ministry of Science and Innovation, Spanish Ministry of Science and Innovation, Ministry of Science and Innovation of Spain, Spain, Ministry for Science and Innovation, Ministeri de Ciència i Innovació, MCIN, MICINN
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Spain
Results and Publications
Publication and dissemination plan
The exploitation of iBoneFIT results will concern the following steps: (i) identifying the exploitable results, (ii) identifying the best exploitation strategy for every result, (iii) monitoring the market needs and the target users, and (iv) establishing a good communication channel among industry, academia and market. The host institution will consider open source exploitation strategies in order to gain visibility. The Research and Knowledge Transfer office (OTRI) (http://otri.ugr.es/), provides professional support for researchers, evaluating the research and outputs and managing the University research’s strategy. iBoneFIT will promote Open Access publications, according to the 2003 Berlin Declaration. Publications will be uploaded to the Universities open access repositories.
Intention to publish date
01/06/2024
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/10/2020 | 14/10/2020 | Yes | No |