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

March 10, 2021 updated by: Marietta van der Linden, Queen Margaret University

The Effect of RaceRunning on Cardiometabolic Disease Risk Factors and Functional Mobility in Young People With Moderate-to-severe Cerebral Palsy: a Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Gloucester, United Kingdom
        • Recruiting
        • University of Gloucestershire
        • Contact:
      • Musselburgh, United Kingdom, EH21 6UU
        • Recruiting
        • Queen Margaret University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum aerobic capacity (VO2max)
Time Frame: 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)
Baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Collaborators

University of Edinburgh
Brunel University
University of Gloucestershire

Investigators

  • Principal Investigator: Marietta L van der Linden, PhD, Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 259279

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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