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

NCT04034342 | Unknown

• 1 other identifier: 259279
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Exercise; Cerebral Palsy

Keywords

RaceRunning;; cardiometabolic health desease risk; functional mobility

Outcome Measures

Primary Outcomes (1)

• maximum aerobic capacity (VO2max)

  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)

  Baseline, 12 weeks and 24 weeks

Secondary Outcomes (10)

• Physical activity

  Baseline, 12 weeks and 24 weeks

• sedentary behaviour

  Baseline, 12 weeks and 24 weeks

• Resting heart rate (beats per min)

  Baseline, 12 weeks and 24 weeks

• Resting heart rate blood pressure (mmHg)

  Baseline, 12 weeks and 24 weeks

• Functional mobility Scale

  Baseline, 12 weeks and 24 weeks

Interventions

RaceRunning OTHER

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.

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Margaret University: lead
• Brunel University: collaborator
• University of Gloucestershire: collaborator
• University of Edinburgh: collaborator

Study Sites (2)

University of Gloucestershire

Gloucester, United Kingdom

RECRUITING

Queen Margaret University

Musselburgh, EH21 6UU, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 32611743 DERIVED

MeSH Terms

Conditions

Motor Activity; Cerebral Palsy

Condition Hierarchy (Ancestors)

Behavior; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marietta L van der Linden, PhD

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marietta van der Linden, PhD

CONTACT

0131 4740000; mvanderlinden@qmu.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 26, 2019
• Study Start: October 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

GB (2)