Study protocol for Running for Health (Run4Health): a randomized controlled trial investigating the effect of Frame Running (RaceRunning) training on cardiovascular health in children and youth with cerebral palsy

Introduction It is well established that young people with moderate-severe (Gross Motor Function Classification System [GMFCS] levels II-V) cerebral palsy (CP) participate in less physical activity compared to typically developed peers, and children with CP who can walk without limitations (GMFCS level I). Frame Running (formerly RaceRunning) is a World Para Athletics sanctioned sport that allows people with moderate-severe CP to access, experience and compete in running using a specialised three-wheeled frame with low rolling resistance. The Run4Health pilot randomised controlled trial (protocol published elsewhere) was designed to investigate the cardiorespiratory benefits of a 12-week frame running training program in young people with CP (aged 8-21 years, GMFCS II-V). Following enrolment of 12 participants in the pilot study, additional funding was secured to expand the Run4Health study to include additional training/study sites, new research questions and outcome measures, based on feedback from consumers. Such changes necessitate an expanded and updated study protocol. This expanded Run4Health study will investigate the effects of a 12- week Frame Running training program on cardiorespiratory health, bone mineral density, gross motor function and capacity, physical activity participation, sleep, pain and quality of life in children and youth (aged 8-21 years) with moderate-severe CP (GMFCS levels II-V). Methods and Analysis One hundred and two children and youth with CP (age 8-21 years) classified in GMFCS levels II-V will be recruited across three sites (six training locations) and randomised to receive either 12 weeks of Frame Running training twice weekly for 60 minutes, or 12 weeks of usual care (waitlist control group). Outcomes will be measured at baseline, immediately post-intervention, and 12 weeks post-intervention. The control group will receive the intervention following T3, and have an additional assessment session following 12 weeks of training (T4). Outcomes include cardiorespiratory fitness, bone mineral density, blood pressure, habitual physical activity, body mass index, waist circumference, percentage body fat, gross motor function and capacity, community participation, sleep, pain, quality of life and mood, health utility, feasibility, tolerability, and safety. Adverse events will be monitored, and participants, caregivers and coaches will be interviewed to explore barriers and facilitators to ongoing, sustainable participation in Frame Running. Ethics and Dissemination Ethical approval for this study was granted by The Children’s Health Queensland Hospital and Health Service (HREC/21/QCHQ/69281) and the University of Queensland Human Research Ethics Committees (2021/HE000725). Research outcomes will be disseminated via scientific conferences and publications in peer reviewed journals; to therapists and coaches through professional and athletic organisations; and to people with CP and their families. Registration Australian New Zealand Clinical Trials Registry number: ACTRN12621000317897 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12621000317897 ### Funding Statement The Run4HealthCP trial is financially supported by an Early Career Research Project Support Grant awarded by the Children's Hospital Foundation (grant ID: ECR0262020), the Dr June Canavan Foundation, the Merchant Charitable Foundation via the Children's Hospital Foundation (donation ID: 10415), the Medical Research Future Fund (MRFF) via National the Australian National Health and Medical Research Council (NHMRC) 2021 Early to Mid-Career Researchers grant (2022624) and NHMRC Research Fellowship grant (RNB). Assistive technology supplier Dejay Medical Pty Ltd has agreed to provide at least a 30% discount on Running Frames required to be purchased for the trial. Other running frames used in the trial will be borrowed at no cost (except return freight) from various individuals and organisations. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Childrens Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/21/QCHQ/69281) and the University of Queensland Human Research Ethics Committee (2021/HE000725) gave ethical approval for this work. The trial is also registered on the Australian New Zealand Clinical Trials Registry (ANZCTR ACTRN12621000317897). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data produced from the present study will be disseminated in scientific journals (manuscripts) on study completion.