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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034342
• Other study ID #: 259279
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2021
• Source: Queen Margaret University
• Contact: Marietta van der Linden, PhD
• Phone: 0131 4740000
• Email: mvanderlinden[@]qmu.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Exercise

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Gloucestershire	Gloucester
United Kingdom	Queen Margaret University	Musselburgh

Sponsors (4)

Lead Sponsor	Collaborator
Queen Margaret University	Brunel University, The University of Edinburgh, University of Gloucestershire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical activity	The number of steps over five 24 hour periods will be recorded using an activity monitor.	Baseline, 12 weeks and 24 weeks
Secondary	sedentary behaviour	The time (in minutes) spent in an lying or sitting over five 24 hour periods will recorded using an activity monitor.	Baseline, 12 weeks and 24 weeks
Secondary	Resting heart rate (beats per min)	The average heart rate during 2 minutes of quiet sitting	Baseline, 12 weeks and 24 weeks
Secondary	Resting heart rate blood pressure (mmHg)	The average blood pressure during 2 minutes of quiet sitting	Baseline, 12 weeks and 24 weeks
Secondary	Functional mobility Scale	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.	Baseline, 12 weeks and 24 weeks
Secondary	Muscle strength	Knee extensor strength (N) will be assessed with a hand-held dynamometry	Baseline, 12 weeks and 24 weeks
Secondary	calf and waist circumference (mm)	The circumference of the calf and waist will be measured using a tape measure	Baseline, 12 weeks and 24 weeks
Secondary	Quality of Life (EQ-5D)	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.	Baseline, 12 weeks and 24 weeks
Secondary	The Canadian Occupational Performance Measure	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.	Baseline, 12 weeks and 24 weeks
Secondary	Psychosocial Impact of Assistive Devices Scale (PIADS)	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).	Baseline, 12 weeks and 24 weeks