Condition category
Cancer
Date applied
27/03/2020
Date assigned
02/04/2020
Last edited
14/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 June 2022

Who is funding the study?
“la Caixa” Foundation (Spain)

Who is the main contact?
Dr Luis Andrés Gracia Marco, lgracia@ugr.es

Trial website

http://profith.ugr.es/?lang=en

Contact information

Type

Public

Primary contact

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 number

Nil known

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

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

Trial setting

Internet

Trial 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

Phase

Drug names

Primary outcome measure

Current primary outcome measures as of 11/08/2020:
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 11/08/2020:
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 trial start date

01/05/2019

Overall trial end date

25/06/2022

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

Patient

Age group

Child

Gender

Both

Target number of participants

A minimum of 116 participants (58 per group)

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

30/09/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Virgen de las Nieves Hospital
Ribera del Beiro, s/n
Granada
18014
Spain

Trial 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

http://www.ugr.es/

Funders

Funder type

Charity

Funder name

“la Caixa” Foundation

Alternative name(s)

Caixa Foundation, “la Caixa”, Fundación Bancaria Caixa d’Estalvis i Pensions de Barcelona, Fundación Caixa

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

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.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Intention to publish date

31/12/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/33032564/ (added 14/10/2020)

Publication citations

Additional files

Editorial Notes

14/10/2020: Publication reference added. 14/08/2020: Regional University Hospital of Málaga was removed from the trial participating centres. 11/08/2020: The interventions and primary and secondary outcome measures were updated. The recruitment start date was changed from 01/08/2020 to 01/09/2020. 10/07/2020: The following changes were made to the trial record: 1. The public title was changed from "Improving bone health in paediatric cancer survivors" to "Improving bone health in paediatric cancer survivors through exercise". 2. The scientific title was changed from "Effect of an exercise program on bone health in paediatric cancer survivors" to "Effect of an online exercise program on bone health in paediatric cancer survivors". 3. The overall end date was changed from 30/04/2022 to 25/06/2022. 4. The recruitment start date was changed from 01/05/2020 to 01/08/2020. 5. The recruitment end date was changed from 15/06/2020 to 30/09/2020. 6. The plain English summary was updated to reflect these changes. 10/07/2020: The following changes have been made: 1. The target number of participants has been changed from "A minimum of 102 participants (51 per group)" to "A minimum of 116 participants (58 per group)". 2. The intention to publish date has been changed from 31/12/2024 to 31/12/2022. 02/04/2020: Trial’s existence confirmed by Junta de Andalucia