Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000317897
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
22/03/2021
Date last updated
8/05/2023
Date data sharing statement initially provided
22/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 303171 0
ECR0262020
Universal Trial Number (UTN)
U1111-1263-8349
Trial acronym
RUN4HEALTH CP
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 320291 0
cardiovascular fitness 320292 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318216 318216 0 0
Physiotherapy
Neurological 318217 318217 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 319471 0
Rehabilitation
Intervention code [2] 319472 0
Lifestyle
Intervention code [3] 320057 0
Treatment: Devices
Comparator / control treatment
Waitlist control usual care:
Participants in the waitlist control 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 RaceRunning training or practice**. Participants and/or their caregivers will be asked to complete a diary of usual care therapies and any RaceRunning training or practice**. At the follow-up/retention timepoint (T3, 26 weeks) participants in the waitlist control usual care group will then receive the RaceRunning training intervention.

**Restriction on completing RaceRunning training or practice:
The control group will be asked NOT to participate in RaceRunning during the control period to avoid contamination. This however may introduce inequity of access to the intervention (as this is not a waitlist controlled trial). To address this, after the end of the trial participants in the control group will be provided with an information package and up to two phone calls with the study therapist for personalized support to access RaceRunning in the community. This includes referral to local providers and funding mechanisms. The information package is being designed specifically for the study and is not readily available.
Control group
Active

Outcomes
Primary outcome [1] 326202 0
Distance (metres) covered in the Six Minute RaceRunner Test (6MRRT). The 6MRRT is a validated measure of RaceRunning endurance with good test-retest reliability (ICC=0.78-0.91) in children functioning at GMFCS III and IV. The 6MRRT is theoretically a submaximal exercise test, however it is likely that most participants will achieve almost maximal heart rate.
Timepoint [1] 326202 0
Assessed immediately post-intervention (12 weeks)
Secondary outcome [1] 390493 0
Distance (metres) covered in the Six Minute RaceRunner Test (6MRRT). The 6MRRT is a validated measure of RaceRunning endurance with good test-retest reliability (ICC=0.78-0.91) in children functioning at GMFCS III and IV. The 6MRRT is theoretically a submaximal exercise test, however it is likely that most participants will achieve almost maximal heart rate.
Timepoint [1] 390493 0
Assessed at 12 weeks post-intervention completion (retention).
Secondary outcome [2] 390494 0
Heart Rate Recovery in 1 minute (HRR1min) will be taken immediately following the 6MRRT. HRR1min is strongly associated with cardiac mortality, and is responsive to a 12- week cardiac rehabilitation program in children following heart surgery. Children will wear a Polar OH1 Optical HR monitor on the upper arm during testing.
Timepoint [2] 390494 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention)
Secondary outcome [3] 390495 0
Resting blood pressure will be measured using an automated sphygmomanometer (valid and reliable). Resting systolic and diastolic Blood Pressure (BP) in mmHg is a traditional risk factor for cardiometabolic disease in individuals with CP, and systolic BP is associated with cardiorespiratory fitness, central adiposity and BMI in children with CP. Systolic and diastolic BP were responsive to a 12-week training program in youth with Down Syndrome.
Timepoint [3] 390495 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [4] 390496 0
Accelerometry is valid, reliable and feasible to quantify PA in youth with CP (GMFCS I-III) with CP. Participants will wear an ActiGraph GT3Xplus on the less-affected wrist and less- affected anterior thigh for 7 days during waking hours during their usual activities (free- living). Data will be processed using both intensity threshold methods to determine time spent in moderate-vigorous PA, light PA and sedentary time, and activity recognition methods using machine learning algorithms. We (Boyd) have validated a combined thigh and wrist classification model in children functioning at GMFCS III and IV.
Timepoint [4] 390496 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [5] 390497 0
The Participation and Environment Questionnaire (PEM-CY) is a parent completed questionnaire with good test-retest reliability and internal consistency. Summary scores for participation frequency, involvement, and percent environmental supportiveness for the community domain will be calculated.
Timepoint [5] 390497 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).,
Secondary outcome [6] 390498 0
GMFM-66 is a criterion referenced observation measure developed using Rasch modelling to measure gross motor function of children with CP. The GMFM-66 has established construct validity, high test retest reliability (ICC 0.99) and is responsive to change (MCID=1.5).
Timepoint [6] 390498 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [7] 390499 0
Body mass index (BMI, kg/m squared): will calculated according to the equation: BMI = weight (kg)/height squared (m). Weight will be determined using calibrated Seca™ chair scales. Height will be determined using a stadiometer or if the participant is not able to lie or stand due to severe impairments including knee flexion contracture, then height will be estimated from knee height.
Timepoint [7] 390499 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [8] 390500 0
Waist circumference (cm): will be measured to the nearest millimetre according to standard methods.
Timepoint [8] 390500 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [9] 390501 0
Body composition - Fat mass (grams and % body fat): Dual energy x-ray absorptiometry (DXA) will be used in place of callipers to determine fat mass.

DXA is a three-compartment measure of bone and body composition that derives bone mineral content and soft tissue mass separately, and estimates the latter into fat and lean body mass. Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [9] 390501 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [10] 392154 0
Wong-Baker FACES® rating scale (pain)
Timepoint [10] 392154 0
Assessed at each RaceRunning training session.
Secondary outcome [11] 392155 0
Fatigue Severity Scale FSS (fatigue)
Timepoint [11] 392155 0
Assessed at each RaceRunning training session.
Secondary outcome [12] 392156 0
Training load composite outcome (Rate of Perceived Exertion (RPE) on OMNI RPE multiplied by session duration).
Timepoint [12] 392156 0
Assessed at each RaceRunning training session.
Secondary outcome [13] 392157 0
Monitoring of adverse and unintended events including injuries will be undertaken throughout the study.
Timepoint [13] 392157 0
All timepoints and RaceRunning training sessions.
Secondary outcome [14] 393094 0
Sport-specific activity limitation test 1: Distance covered in four strides (metres). Observed by a trained assessor standing adjacent to the track lane. Measured with retractable fibreglass measuring tape from the start position to the position observed for the ground contact that completes the 4th stride. One stride is a complete gait cycle for a single leg (e.g. toe-off to initial contact of the left leg). The athlete is encouraged if possible to use reciprocal/alternating gait. If the athlete is unable, they must pick one leg to perform single-leg pushes or must consistently use double-leg pushes.
Timepoint [14] 393094 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [15] 393095 0
Sport-specific activity limitation test 2: number of ground contacts in 20 metres. The 20-metre distance is standardized by measurement with retractable fibreglass measuring tape and marked by cones. A trained observer stands adjacent to the track lane and counts the number of ground contacts completed in the 20 metre distance. If the athlete uses a double-leg push strategy, one contact is counted if the feet contact the ground at the same time, but two contacts are counted if the athlete travels any distance between the contacts. An accidental foot drag that does not contribute to propulsion is not counted.
Timepoint [15] 393095 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [16] 393096 0
Sport-specific activity limitation test 3: 100m sprint time (seconds). The 100-metre distance is standardized by measurement with retractable fibreglass measuring tape and marked by cones. A trained observer stands adjacent to the track lane and stands at the finish line and times the sprint with a stopwatch. The athlete begins with the front wheel behind the start line and the stopwatch is stopped as the front axle passes the finish line.
Timepoint [16] 393096 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [17] 421726 0
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) mobility domain is a parent-report, standardized, norm-referenced assessment of mobility performance that is valid up to 21 years, reliable (ICC=0.98), responsive in CP and correlated with gross motor capacity.

Only the mobility domain will be assessed/reported.
Timepoint [17] 421726 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [18] 421727 0
Sleep duration will be analysed from wrist accelerometer data (collected as per physical activity measurement above) using algorithms validated in children with CP.

Sleep duration, efficiency, wake after sleep onset and sleep latency will be analysed separately (listed as separate outcomes)
Timepoint [18] 421727 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [19] 421728 0
Subjective sleep: Pittsburgh Sleep Questionnaire Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances (analysed as a composite outcome, including - quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction) over a 1-month period.
Timepoint [19] 421728 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [20] 421729 0
Lung function - respiratory system resistance (airway obstruction)

Intrabreath oscillometry (IB-OSC) will be performed on the Thorasys TremoFLO device. Participants will perform 3 x 20-second recordings of tidal breathing using a 10Hz sinusoidal waveform. IB-OSC measures respiratory system resistance (airway obstruction) reactance (lung compliance), and ventilation homogeneity (evenness of gas mixing), which will be analysed as separate outcomes.
Timepoint [20] 421729 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [21] 421730 0
Lung function: diaphragm (maximal inspiratory pressures [MIPS], sniff nasal inspiratory pressures [SNIPs]) and abdominal/intercostal muscles (maximal expiratory pressures [MEPS]) strength will be performed using the Carefusion MicroRPM device according to ATS/ERS standards. Participants will perform a maximum inhalation or exhalation manoeuvre against a known resistance. A minimum of 3 acceptable measurements are required.
Timepoint [21] 421730 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [22] 421731 0
Cerebral Palsy Quality of Life Q Child/Teen (CP QOL) for participants 8-18 years assesses condition-specific quality of life/wellbeing using parent-report (8-12 years) and child self-report (9-18 years). This outcome will be analysed as a composite measure.
Timepoint [22] 421731 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [23] 421732 0
Health Utility (8-17 years): Child Health Utility 9 Dimensions (CHU-9D) is a generic questionnaire completed by the child or their caregiver by proxy giving a single preference-based utility index for health states, making the data amenable for economic evaluations of interventions. CHU9D will be used in a cost-consequences analysis to support health-economic evaluation. This outcome will be analysed as a composite measure.
Timepoint [23] 421732 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [24] 421733 0
Health Utility (18-21 years): The EQ-5D-5L is a generic health status self-report Questionnaire that measures health across five levels of severity which is commonly used in health economic evaluations. EQ-5D-5L will be used in a cost-consequences analysis to support health-economic evaluation.

This outcome will be analysed as a composite measure.
Timepoint [24] 421733 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [25] 421734 0
Canadian Occupational Performance Measure (COPM) - Performance Score. Children will set three goals related to Frame Running activity and participation. COPM performance and satisfaction scores will be analysed separately (reported as separate outcomes).
Timepoint [25] 421734 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [26] 421735 0
Behaviour Assessment System for Children (BASC- 3) is a parent rated questionnaire of child socioemotional development across internalizing and externalizing problems including aggression, anxiety, inattention, conduct problems and withdrawal. It will be used to measure mental health at T1-T2. This outcome will be analysed as a composite measure.
Timepoint [26] 421735 0
Assessed immediately post-intervention (12 weeks) only.
Secondary outcome [27] 421736 0
Total body composition - lean mass (grams): Dual energy x-ray absorptiometry (DXA) will be used to determine lean mass (grams).

DXA is a three-compartment measure of bone and body composition that derives bone mineral content and soft tissue mass separately, and estimates the latter into fat and lean body mass. Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [27] 421736 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [28] 421737 0
Age/height matched bone mineral density (aBMD: g/cm2) – total body

Dual energy x-ray absorptiometry (DXA) will be used to determine total body bone mineral density (g/cm2).

Dual energy x-ray absorptiometry (DXA) – Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [28] 421737 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [29] 421738 0
Age/height matched bone mineral content (BMC: grams) – total body

Dual energy x-ray absorptiometry (DXA) will be used to determine total body bone mineral content (grams).

Dual energy x-ray absorptiometry (DXA) - Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [29] 421738 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [30] 421739 0
Age/height matched bone mineral density (aBMD: g/cm2) – AP lumbar spine (L1-4)

Dual energy x-ray absorptiometry (DXA) will be used to determine bone mineral density – AP Lumber Spine (L1-L4).

Dual energy x-ray absorptiometry (DXA) - Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [30] 421739 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [31] 421740 0
Age/height matched bone mineral content (BMC: grams) – AP lumbar spine (L1-4)

Dual energy x-ray absorptiometry (DXA) will be used to determine bone mineral content (BMC: grams) – AP lumbar spine (L1-4).

Dual energy x-ray absorptiometry (DXA) - Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [31] 421740 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [32] 421741 0
Age/height matched bone mineral density (aBMD: g/cm2) – Lateral distal femurs
Dual energy x-ray absorptiometry (DXA) will be used to determine bone mineral density (aBMD: g/cm2) – Lateral distal femurs.

Dual energy x-ray absorptiometry (DXA) - Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [32] 421741 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [33] 421742 0
Age/height matched bone mineral content (BMC: grams) – Lateral distal femurs
Dual energy x-ray absorptiometry (DXA) will be used to determine bone mineral content (BMC: grams) – Lateral distal femurs.

Dual energy x-ray absorptiometry (DXA) - Age/height matched bone mineral density (aBMD; g/cm2), bone mineral content (BMC; grams) at total body, AP lumbar spine, and both lateral distal femurs (LDF), lean and fat mass will be extracted and analysed as separate outcomes. Both lateral distal femora are scanned and aBMD subregions averaged. Lumbar spine is used to calculate bone mineral apparent density (BMAD, g/cm3), from the projected bone area (cm2) to provide volumetric BMD.

Estimated time 25 minutes at T1-T2 only. The total radiation dose for the DXA scans (two in total) being <8 µSv, approximately 1 day natural radiation and 1.5% of the dose limit for <18 year olds. European spine phantom will be used to standardise between sites
Timepoint [33] 421742 0
Assessed immediately post-intervention (12 weeks).
Secondary outcome [34] 421743 0
Sleep efficiency will be analysed from wrist accelerometer data (collected as per physical activity measurement above) using algorithms validated in children with CP.

Sleep duration, efficiency, wake after sleep onset and sleep latency will be analysed separately (listed as separate outcomes)
Timepoint [34] 421743 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [35] 421744 0
‘Wake after sleep onset’ will be analysed from wrist accelerometer data (collected as per physical activity measurement above) using algorithms validated in children with CP.

Sleep duration, efficiency, wake after sleep onset and sleep latency will be analysed separately (listed as separate outcomes)
Timepoint [35] 421744 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [36] 421745 0
Sleep latency will be analysed from wrist accelerometer data (collected as per physical activity measurement above) using algorithms validated in children with CP.

Sleep duration, efficiency, wake after sleep onset and sleep latency will be analysed separately (listed as separate outcomes)
Timepoint [36] 421745 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [37] 421746 0
Canadian Occupational Performance Measure (COPM) - Satisfaction Score. Children will set three goals related to Frame Running activity and participation. COPM performance and satisfaction scores will be analysed separately (reported as separate outcomes).
Timepoint [37] 421746 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [38] 421747 0
Lung function - Sniff Nasal Inspiratory Pressures [SNIPs]

Diaphragm (maximal inspiratory pressures [MIPS], sniff nasal inspiratory pressures [SNIPs]) and abdominal/intercostal muscles (maximal expiratory pressures [MEPS]) strength will be performed using the Carefusion MicroRPM device according to ATS/ERS standards and analysed as separate outcomes. Participants will perform a maximum inhalation or exhalation manoeuvre against a known resistance. A minimum of 3 acceptable measurements are required.
Timepoint [38] 421747 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [39] 421748 0
Lung function - abdominal/intercostal muscles (maximal expiratory pressures [MEPS]) strength

Diaphragm (maximal inspiratory pressures [MIPS], sniff nasal inspiratory pressures [SNIPs]) and abdominal/intercostal muscles (maximal expiratory pressures [MEPS]) strength will be performed using the Carefusion MicroRPM device according to ATS/ERS standards and analysed as separate outcomes. Participants will perform a maximum inhalation or exhalation manoeuvre against a known resistance. A minimum of 3 acceptable measurements are required.
Timepoint [39] 421748 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).
Secondary outcome [40] 421749 0
Lung function - reactance (lung compliance) and ventilation homogeneity (evenness of gas mixing)
Intrabreath oscillometry (IB-OSC) will be performed on the Thorasys TremoFLO device. Participants will perform 3 x 20-second recordings of tidal breathing using a 10Hz sinusoidal waveform. IB-OSC measures respiratory system resistance (airway obstruction) reactance (lung compliance), and ventilation homogeneity (evenness of gas mixing), which will be analysed as separate outcomes.
Timepoint [40] 421749 0
Assessed immediately post-intervention (12 weeks) and 12 weeks post-intervention completion (Retention).

Eligibility
Key inclusion criteria
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.
Minimum age
8 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence is generated and uploaded to the randomization module of the REDCap database by non-study personnel. Randomization is completed following the baseline assessment, and therefore participants, their caregivers and assessing therapists/coaches are blind to participant allocation until after the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will stratified according to GMFCS (II-III/IV-V) and site (Brisbane vs Cairns vs Sydney vs Sunshine Coast vs Gold Coast vs Perth) then randomized to RaceRunning training (n=31) or Control (n=31) by using a computer-generated random sequence hosted on the randomization module of the REDCap database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Waitlist control. Participants in the control group receive the intervention after T3 retention timepoint.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on the primary outcome of 6MRRT which has a smallest detectable difference of approximately 150m and sample SD of 150m, a sample size of n=44 will detect at least this difference at 90% power and alpha 0.05. To allow for up to 15% attrition, n=52 (n=26 per group) will be recruited at minimum. Due to additional funding awarded to support expansion of Frame Running at additional sites (Sunshine Coast, Gold Coast and Perth), up to 105 participants can be accommodated. Analyses will follow standard principles for RCTs using two group comparisons on all participants on an intention-to-treat basis. Primary comparison immediately post intervention (T2) will be based on distance on 6MRRT. Effect estimates will be presented as mean difference and 95% confidence interval with a significance level of p<0.05. Qualitative interview transcripts will be thematically analysed following transcription with a content analysis approach. Data will be entered, stored and managed using two secure, Australian cloud databases, the UQ Research Data Manager (UQRDM) and REDCap.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2021
Actual
16/09/2021
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
105
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 18959 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 18960 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 18962 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 24688 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 33466 0
4101 - South Brisbane
Recruitment postcode(s) [2] 33467 0
2031 - Randwick
Recruitment postcode(s) [3] 33469 0
2145 - Westmead
Recruitment postcode(s) [4] 36281 0
4870 - Cairns
Recruitment postcode(s) [5] 40310 0
4556 - Sippy Downs
Recruitment postcode(s) [6] 40311 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 307583 0
University
Name [1] 307583 0
The University of Queensland
Country [1] 307583 0
Australia
Funding source category [2] 310438 0
Charities/Societies/Foundations
Name [2] 310438 0
The Children's Hospital Foundation Queensland (ECR0262020) incorporating the Merchant Charitable Foundation and Dr June Canavan Foundation
Country [2] 310438 0
Australia
Funding source category [3] 313800 0
Government body
Name [3] 313800 0
Medical Research Futures Fund, National Health and Medical Research Council (2022624)
Country [3] 313800 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Child Health Research Centre
QCPRRC, Level 6, CCHR
62 Graham Street
SOUTH BRISBANE, QLD, 4101
Country
Australia
Secondary sponsor category [1] 308271 0
None
Name [1] 308271 0
Address [1] 308271 0
Country [1] 308271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307637 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 307637 0
Ethics committee country [1] 307637 0
Australia
Date submitted for ethics approval [1] 307637 0
18/01/2021
Approval date [1] 307637 0
18/03/2021
Ethics approval number [1] 307637 0
HREC21QCHQ69281
Ethics committee name [2] 310077 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 310077 0
Ethics committee country [2] 310077 0
Australia
Date submitted for ethics approval [2] 310077 0
19/03/2021
Approval date [2] 310077 0
20/05/2021
Ethics approval number [2] 310077 0
2021/HE000725

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107954 0
Dr Sarah E Reedman
Address 107954 0
The University of Queensland Child Health Research Centre, Queensland Cerebral Palsy and Rehabilitation Research Centre
QCPRRC, Level 6, CCHR
62 Graham Street
SOUTH BRISBANE, QLD, 4101
Country 107954 0
Australia
Phone 107954 0
+61 7 30697370
Fax 107954 0
Email 107954 0
[email protected]
Contact person for public queries
Name 107955 0
Laura Gascoigne-Pees
Address 107955 0
The University of Queensland Child Health Research Centre, Queensland Cerebral Palsy and Rehabilitation Research Centre
QCPRRC, Level 6, CCHR
62 Graham Street
SOUTH BRISBANE, QLD, 4101
Country 107955 0
Australia
Phone 107955 0
+61730697370
Fax 107955 0
Email 107955 0
[email protected]
Contact person for scientific queries
Name 107956 0
Sarah E Reedman
Address 107956 0
The University of Queensland Child Health Research Centre, Queensland Cerebral Palsy and Rehabilitation Research Centre
QCPRRC, Level 6, CCHR
62 Graham Street
SOUTH BRISBANE, QLD, 4101
Country 107956 0
Australia
Phone 107956 0
+61 7 30697370
Fax 107956 0
Email 107956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD and related data dictionaries are available.
When will data be available (start and end dates)?
All individual participant data collected in the trial, following de-­identifcation.
Available to whom?
Researchers who provide a methodologically sound proposal, and appropriate/ethical data management plan.
Available for what types of analyses?
IPD meta­-analysis.
How or where can data be obtained?
Data can be obtained by contacting the Principal Investigator Dr Sarah Reedman, [email protected], +61 7 3069 7370.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for Running for health (Run4Health CP): A multicentre, assessor-blinded randomised controlled trial of 12 weeks of two times weekly Frame Running training versus usual care to improve cardiovascular health risk factors in children and youth with cerebral palsy.2022https://dx.doi.org/10.1136/bmjopen-2021-057668
N.B. These documents automatically identified may not have been verified by the study sponsor.