Clinical trial NCT04034342: RaceRunning for Young People With Moderate-to-severe Cerebral Palsy
Official title: The Effect of RaceRunning on Cardiometabolic Disease Risk Factors and Functional Mobility in Young People With Moderate-to-severe Cerebral Palsy: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exercise
Cerebral Palsy
Keywords: RaceRunning;
cardiometabolic health desease risk
functional mobility
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Brunel University
name: University of Gloucestershire
name: University of Edinburgh
First posted: 2019-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is envisaged that the cohort will be recruited from a variety of RaceRunning clubs in Scotland: Meadowmill RaceRunning squad, Pitreavie AC (Dumfermline), if required Perth AC, Forth Valley Flyers, Ayr Seaforth AC and Glasgow Victoria Park AC. The participants in England will be recruited from Gloucester athletics club and Milestones school.

The RaceRunning clubs and the study will be advertised through appropriate social media channels (Facebook, Twitter) and websites such as Scottish Disability Sport, Cerebral Palsy Scotland, CP Sport England etc. to further increase the recruitment potential.

Brief summary: Physical inactivity in people with cerebral palsy (CP) has been linked with increased risk of cardiometabolic disease. Exercise studies rarely include people with CP with severe walking impairments and assess the sustainability of the intervention. RaceRunning allows people severe walking impairments to independently propel themselves using a running bike, which has a breast plate for support but no pedals. This project will assess the feasibility of at trial into the effectiveness of RaceRunning to reduce cardiometabolic disease risk factors and improve functional mobility. Intervention: Weekly standardised RaceRunning sessions over 6 months led by an experienced coach. Participants Twenty-five young people with CP aged 5-21, GMFCS levels III-V. Feasibility outcomes: Acceptability of RaceRunning, adherence and fidelity of the intervention, recruitment and retention rates and adverse events. Outcome measures: Cardiometabolic disease risk factors (physical activity, sedentary time, resting heart rate and blood pressure and aerobic capacity) and functional mobility assessed at baseline, 3 and 6 months. Quality of life (EQ-5D-Y) and health service use will inform a future cost-effectiveness analysis. Aspects of feasibility and acceptability and the variability and patterns of the change in outcomes will be reported using descriptive statistics.

Detailed description: This is a multi-centre experimental study with a single intervention arm. Assessments will be conducted at baseline, 12 weeks and 24 weeks. The intervention will be delivered in Scotland and Gloucestershire. Participants will take part in one RaceRunning session each week for a period of 24 weeks. The content of the sessions will be standardised for all training groups and will consist of a warm-up, coordination (drills), sprint and endurance training, and cool-down. The training program will be adapted to the athlete's ability and fitness. The project objectives are to examine the feasibility of delivering and acceptability of participating in RaceRunning as a community-based intervention for young people with moderate-to-severe CP, including fidelity to and safety of the intervention. Secondly, to examine the feasibility of conducting a definitive study of RaceRunning including exploring recruitment and retention over 24 weeks, acceptability of data collection methods and rate of outcome measure completion, and acceptability and quantity of missing data relating to health economic data collection tools. Finally, to examine the variability and patterns of change in outcomes over 24 weeks in order to determine a primary outcome measure and calculate sample size for a future study.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of cerebral palsy or brain injury affecting coordination
* Aged 5 to 21
* GMFCS E-R level III, IV or V
* Less than 15 hours of RaceRunning experience
* Able to independently propel the bike for at least 30 meters
* An ability to comprehend and follow instructions relating to participation in RaceRunning training

Exclusion Criteria:

* Lower limb surgery
* Having started Botox or other spasticity treatment less than 6 months prior to the start of the study
* Severe visual impairment affecting the ability to safely take part in RaceRunning training sessions

Primary outcomes:
measure: maximum aerobic capacity (VO2max)
timeFrame: Baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 12 weeks and 24 weeks
measure: sedentary behaviour
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Resting heart rate (beats per min)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Resting heart rate blood pressure (mmHg)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Functional mobility Scale
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Muscle strength
timeFrame: Baseline, 12 weeks and 24 weeks
measure: calf and waist circumference (mm)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Quality of Life (EQ-5D)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: The Canadian Occupational Performance Measure
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: University of Gloucestershire
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University
Study officials:
affiliation: Queen Margaret University
name: Marietta L van der Linden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan J, Theis N, Koufaki P, Phillips S, Anokye N, Andreopoulou G, Kennedy F, Jagadamma KC, vanSchie P, Dines H, van der Linden ML. Effect of RaceRunning on cardiometabolic disease risk factors and functional mobility in young people with moderate-to-severe cerebral palsy: protocol for a feasibility study. BMJ Open. 2020 Jul 1;10(7):e036469. doi: 10.1136/bmjopen-2019-036469.