Running for health: a randomized controlled trial investigating the effect of Frame Running (RaceRunning) training on cardiovascular health in children and youth with cerebral palsy.
A randomized controlled trial of Frame Running (RaceRunning) training compared to usual care on cardiovascular fitness, body composition, physical activity, community participation, functional strength, gross motor ability, lung function, bone health, sleep, mental wellbeing, and quality of life in children and youth with cerebral palsy aged 8-20 years, classified in Gross Motor Function Classification Levels II-V.
The University of Queensland
105 participants
Sep 16, 2021
Interventional
Conditions
Summary
Children with cerebral palsy (CP) who have difficulty walking or cannot walk have low physical activity levels and very high sedentary behaviour. When they become adults they have at least a 3-fold increased risk of dying from cardiovascular disease compared to people without CP. There are few high quality clinical trials of interventions to improve physical activity in this population, and none that specially target risk factors for cardiovascular disease. We propose an adequately powered randomized waitlist controlled clinical trial of 12 weeks training in a brand new sport called RaceRunning in342 in 105 children with CP aged 8-21 years who have difficulty walking or cannot walk. RaceRunning is a para-athletic event using a specially designed supportive frame. We will measure the effect of the training on cardiovascular health including cardiovascular fitness, body composition, bone density, lung function, and physical activity. We will also see if it improves community participation, functional strength, mental health, quality of life, sleep and gross motor ability. There will be sites in Brisbane (n=2510), Cairns (n=158), Sunshine Coast (n=170) and Sydney (n=156), Gold Coast (n=18) and Perth (n=15), all involving local experienced clinicians and consumer representatives. If effective, this training could improve future health outcomes for children with CP and be quickly translated into clinical practice and community sport.
Eligibility
Inclusion Criteria6
- Children and youth:
- (a) who have been diagnosed with cerebral palsy classified in GMFCS levels II-V.
- (b) who are between 8.00 to 21.99 years at baseline.
- (c) who live within 150km of one of the trial sites (Brisbane, Cairns, Sydney, Sunshine Coast. Gold Coast and Perth).
- (d) who have completed less than 1o hours of frame running training within the last 6 months.
- (e) who can follow the directions of the coach and assessor for the purposes of training safely and completing outcome measurement in the opinion of the Principal Investigator.
Exclusion Criteria3
- a) child/youth has orthopaedic and/or neurological surgery within 6 months prior to baseline or planned during the study period.
- (b) child has uncontrolled epilepsy, medical fragility, and/or serious precautions not able to be accommodated (e.g. significant history of atraumatic lower limb fractures or sacral pressure injuries etc.) precluding participation in moderate-vigorous intensity RaceRunning.
- (c) Caregiver English language skills are not sufficient to understand the study information, provide informed consent and/or complete study questionnaires.
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Interventions
Frame Running/RaceRunning: Frame Running (also known as RaceRunning) is a new World Para-Athletics sanctioned event and is an accessible physical activity option for people with CP of all ages. RaceRunner device: The RaceRunner is an innovative supportive running frame suitable for non-ambulant people with CP. This includes children who need walking aids and who cannot stand or sit without assistance. RaceRunners are low-risk Medical Device Class 1 on the Australian Register of Therapeutic Goods. They are manufactured overseas and are imported to Australia by Dejay Medical and Scientific Pty Ltd. There are currently two brands available in Australia, RAD - Trike - Disability vehicle, cycle, tricycle, foot-propelled (ARTG: 345236) and By Connie Hansen - Disability vehicle, cycle, tricycle, foot-propelled (ARTG: 309224). The training intervention provided in this clinical trial: The training (12 weeks duration, 2 x 60mins per week) will be undertaken at synthetic outdoor athletics tracks at each site. Participants will train in groups of 2-3 by a trained Physiotherapist or Exercise Physiologist. Participants will also attend a fun ‘competition’ day at the end of the training period in order to facilitate increased motivation and provide opportunity for participation. The training dose coincides with the principles of exercise training for dose, direction and intensity. Training will be tailored to each child/youth and include: (1) aerobic and anaerobic RaceRunning and (2) task-specific functional training for RaceRunning technique and skills (e.g. braking, steering, lower limb selective motor control, incline/resistance and power). The proposed training content draws upon the expertise of our team in resistance training in young adults with CP, participation-focused therapy to promote participation in sports and physical activities in children with CP, high-intensity functional task-specific motor training in youth with CP, and adapted cycling in youth with CP. Training protocol: The training protocol will be manualized and this will be provided to the interventionists to support consistent delivery of the intervention across participants and sites, and provide a means to translate the intervention. The manual is being developed specifically for this study and is not yet available. Usual care: Participants in the intervention group will continue to receive their usual care treatment which is expected to vary widely in dosage and content. It is expected to include physiotherapy, exercise physiology, occupational therapy, personal training, and/or additional (non-trial) RaceRunning training or practice. Participants and/or their caregivers will be asked to complete a diary of usual care therapies and any independent/additional (non-trial) RaceRunning training or practice. Adherence: Adherence will be monitored using: session attendance and duration checklists. The following outcome measures also provide adherence information: Wong-Baker FACES rating scale (pain), Fatigue Severity Scale, and training load (Rate of Perceived Exertion OMNI RPE multiplied by session duration).
Locations(4)
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ACTRN12621000317897