The Effect of RaceRunning on Cardiometabolic Disease Risk Factors and Functional Mobility in Young People With Moderate-to-severe Cerebral Palsy: a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- maximum aerobic capacity (VO2max)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
maximum aerobic capacity (VO2max)
时间窗: Baseline, 12 weeks and 24 weeks
an incremental test protocol will be used to measure the maximum oxygen uptake (ml/ min kg) an incremental test protocol will be used to measure maximum oxygen uptake (ml/min kg)
次要结局
- sedentary behaviour(Baseline, 12 weeks and 24 weeks)
- Resting heart rate blood pressure (mmHg)(Baseline, 12 weeks and 24 weeks)
- Muscle strength(Baseline, 12 weeks and 24 weeks)
- Physical activity(Baseline, 12 weeks and 24 weeks)
- Quality of Life (EQ-5D)(Baseline, 12 weeks and 24 weeks)
- Psychosocial Impact of Assistive Devices Scale (PIADS)(Baseline, 12 weeks and 24 weeks)
- Resting heart rate (beats per min)(Baseline, 12 weeks and 24 weeks)
- calf and waist circumference (mm)(Baseline, 12 weeks and 24 weeks)
- Functional mobility Scale(Baseline, 12 weeks and 24 weeks)
- The Canadian Occupational Performance Measure(Baseline, 12 weeks and 24 weeks)
研究者
Marietta van der Linden
Senior Research Fellow
Queen Margaret University