RaceRunning for Young People With Moderate-to-severe Cerebral Palsy
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- maximum aerobic capacity (VO2max) [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)
Secondary Outcome Measures
- Physical activity [Baseline, 12 weeks and 24 weeks]
The number of steps over five 24 hour periods will be recorded using an activity monitor.
- sedentary behaviour [Baseline, 12 weeks and 24 weeks]
The time (in minutes) spent in an lying or sitting over five 24 hour periods will recorded using an activity monitor.
- Resting heart rate (beats per min) [Baseline, 12 weeks and 24 weeks]
The average heart rate during 2 minutes of quiet sitting
- Resting heart rate blood pressure (mmHg) [Baseline, 12 weeks and 24 weeks]
The average blood pressure during 2 minutes of quiet sitting
- Functional mobility Scale [Baseline, 12 weeks and 24 weeks]
The Functional Mobility Scale (FMS) will be used to describe the level of a child's mobility in everyday life over 5m, 50m, and 500m and representing the home, school and community settings respectively.
- Muscle strength [Baseline, 12 weeks and 24 weeks]
Knee extensor strength (N) will be assessed with a hand-held dynamometry
- calf and waist circumference (mm) [Baseline, 12 weeks and 24 weeks]
The circumference of the calf and waist will be measured using a tape measure
- Quality of Life (EQ-5D) [Baseline, 12 weeks and 24 weeks]
The EQ-5D-Y/EQ-5D-5L will be used to describe and value the health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- The Canadian Occupational Performance Measure [Baseline, 12 weeks and 24 weeks]
The Canadian Occupational Performance Measure will be used to identify important activities for each participant and to record the change in participants' perceived performance rating of this activity and the satisfaction of this performance over time. psychosocial outcomes such as happiness, self-esteem, independence and quality of life.
- Psychosocial Impact of Assistive Devices Scale (PIADS) [Baseline, 12 weeks and 24 weeks]
The PIADS will be used to record the change in psychosocial outcomes such as happiness, self-esteem, independence and quality of life as a result of using a specific assistive device (RaceRunner).
Eligibility Criteria
Criteria
Inclusion Criteria:
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A diagnosis of cerebral palsy or brain injury affecting coordination
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Aged 5 to 21
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GMFCS E-R level III, IV or V
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Less than 15 hours of RaceRunning experience
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Able to independently propel the bike for at least 30 meters
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An ability to comprehend and follow instructions relating to participation in RaceRunning training
Exclusion Criteria:
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Lower limb surgery
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Having started Botox or other spasticity treatment less than 6 months prior to the start of the study
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Severe visual impairment affecting the ability to safely take part in RaceRunning training sessions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Gloucestershire | Gloucester | United Kingdom | ||
| 2 | Queen Margaret University | Musselburgh | United Kingdom | EH21 6UU |
Sponsors and Collaborators
- Queen Margaret University
- Brunel University
- University of Gloucestershire
- University of Edinburgh
Investigators
- Principal Investigator: Marietta L van der Linden, PhD, Queen Margaret University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 259279