RaceRunning for Young People With Moderate-to-severe Cerebral Palsy

NCT ID: NCT04034342

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-12-30

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.

Conditions

Exercise; Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

RaceRunning

RaceRunning (www.racerunning.org) is a growing disability sport that provides an opportunity for people with moderate-to-severe CP to participate in exercise in the community. It allows those who are unable to walk independently, to propel themselves using a RaceRunning bike, which has a breastplate for support but no pedals. Participants sit on the saddle and use their legs to propel themselves forward.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brunel University

OTHER

Sponsor Role: collaborator

University of Gloucestershire

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Marietta van der Linden

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marietta L van der Linden, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Margaret University

Locations

University of Gloucestershire

Gloucester, , United Kingdom

Site Status: RECRUITING

Queen Margaret University

Musselburgh, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Marietta van der Linden, PhD

Role: CONTACT

mvanderlinden@qmu.ac.uk

0131 4740000

Facility Contacts

Nicola Theis, PhD

Role: primary

ntheis@glos.ac.uk

Georgia Andreopoulou, MSc

Role: primary

gandreopoulou@qmu.ac.uk

0131 4740000

References

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.

Reference Type: DERIVED

PMID: 32611743 (View on PubMed)

Other Identifiers

259279

Identifier Type: -

Identifier Source: org_study_id