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Move to improve: protocol for a single-arm, pragmatic feasibility trial of an individualised physical activity
Hamsini Sivaramakrishnan1,2, Amy Finlay-Jones3,2,4, Jane Valentine3,2,5
1The Kids Research Institute Australia, Nedlands, Western Australia, Australia hamsini.sivaramakrishnan@thekids.org.au.
Insights
This study protocol outlines the Move to Improve trial, testing an 8-week physical activity intervention for children with chronic health conditions. The trial aims to assess feasibility and inform future interventions to enhance physical activity in this population.
Area of Science:
- Pediatric Health
- Rehabilitation Medicine
- Clinical Trials
Background:
- Children with chronic health conditions exhibit lower physical activity levels compared to healthy peers.
- This disparity is attributed to various restrictions impacting participation in physical activities.
- The Move to Improve trial protocol is designed to address this gap.
Purpose of the Study:
- To describe the protocol for the Move to Improve trial, a pragmatic study of an individualized physical activity intervention.
- To test the feasibility of an 8-week hospital-based intervention for children with chronic health conditions.
- To gather data informing service decisions and future research in pediatric physical activity.
Main Methods:
- A single-arm, pragmatic feasibility trial involving 100 children (aged 5-17) with type 1 diabetes, cancer, postburn injuries, or cerebral palsy.
- Assessment of primary outcomes (physical activity, quality of life, goal attainment) and secondary outcomes (aerobic capacity, body composition, motor function, etc.) at baseline, post-intervention, and 6/12-month follow-ups.
- Qualitative data collection via semi-structured interviews with participants and caregivers to assess feasibility, analyzed thematically.
Main Results:
- This section will report descriptive statistics for quantitative data and thematic analysis for qualitative data.
- Primary outcomes include objective moderate to vigorous physical activity, quality of life, and goal attainment.
- Secondary outcomes encompass aerobic capacity, body composition, motor function, grip strength, and psychosocial well-being.
Conclusions:
- The Move to Improve trial protocol provides a framework for delivering and evaluating an individualized physical activity intervention.
- Findings will guide the optimization of interventions to increase physical activity in children with chronic health conditions.
- Data will support evidence-based practices and the design of larger, definitive trials.
Introduction:
Physical activity improves physical and psychosocial outcomes in healthy children and in children with a range of chronic health conditions. Unfortunately, children with chronic health conditions have lower levels of physical activity compared to their healthy peers due to multiple restrictions in physical activities and therefore tend to have lower levels of physical activity compared with their peers. This paper describes the protocol for Move to Improve, a pragmatic trial of an individualised physical activity intervention for children with chronic health conditions.
Methods And Analysis:
Using the RE-AIM framework, this study aims to test the feasibility of Move to Improve, an 8-week hospital-based individualised physical activity intervention. We will recruit 100 children aged 5-17 years who are diagnosed with type 1 diabetes, cancer, postburn injuries and cerebral palsy to a single-arm, pragmatic feasibility trial. The primary outcomes (objective moderate to vigorous physical activity, quality of life and goal attainment) and secondary outcomes (including aerobic capacity, body composition, motor function, grip strength and psychosocial outcomes) will be assessed at baseline, post intervention and at 6-month and 12-month follow-ups. We will conduct semistructured interviews with participants and their primary caregiver at a 2-month follow-up to capture aspects of feasibility. Quantitative data will be reported descriptively, and qualitative data will be analysed using thematic analysis. Data gathered from this study will inform service decision-making and future trials.
Ethics And Dissemination:
The study has received ethics approval from the Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee (RGS6677). Findings of this research will be communicated to the public through peer-reviewed publications, conference presentations, reports, infographics and information sheets. Modifications to the protocol will be outlined in the trial registry and journal publications. Authorship will be in accordance with the International Committee of Medical Journal Editors.
Trial Registration Number:
Australian and New Zealand Clinical Trials Registry Number: ACTRN12624000836538.
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