ExerciseNCT04034342
RaceRunning for Young People With Moderate-to-severe Cerebral Palsy
An observational study of Exercise and Cerebral Palsy, run by Queen Margaret University at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Exercise, Cerebral Palsy
- What is being tested?
- RaceRunning
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2019to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
University of Gloucestershire
Gloucester
Nicola Theis, PhD, ntheis@glos.ac.uk
- Recruiting
Queen Margaret University
Musselburgh, EH21 6UU
Georgia Andreopoulou, MSc, 0131 4740000, gandreopoulou@qmu.ac.uk
About this study
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
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.
Read the 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
- Being tested
- RaceRunning
- Keywords
- RaceRunning;, cardiometabolic health desease risk, functional mobility
- Medical subject headings
- Motor Activity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaceRunningOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (10)
Physical activity
The number of steps over five 24 hour periods will be recorded using an activity monitor.
Measured: Baseline, 12 weeks and 24 weeks
sedentary behaviour
The time (in minutes) spent in an lying or sitting over five 24 hour periods will recorded using an activity monitor.
Measured: Baseline, 12 weeks and 24 weeks
Resting heart rate (beats per min)
The average heart rate during 2 minutes of quiet sitting
Measured: Baseline, 12 weeks and 24 weeks
Resting heart rate blood pressure (mmHg)
The average blood pressure during 2 minutes of quiet sitting
Measured: Baseline, 12 weeks and 24 weeks
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.
Measured: Baseline, 12 weeks and 24 weeks
Muscle strength
Knee extensor strength (N) will be assessed with a hand-held dynamometry
Measured: Baseline, 12 weeks and 24 weeks
calf and waist circumference (mm)
The circumference of the calf and waist will be measured using a tape measure
Measured: Baseline, 12 weeks and 24 weeks
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.
Measured: Baseline, 12 weeks and 24 weeks
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.
Measured: Baseline, 12 weeks and 24 weeks
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).
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Oct 2019
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University, University of Gloucestershire, University of Edinburgh
- Responsible party
- Principal investigator, Marietta van der Linden, Queen Margaret University
- Investigators
- Marietta L van der Linden, PhD, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034342
- Sponsor's protocol ID
- 259279
- Status last verified
- Mar 2021
- First submitted
- 15 Jul 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32611743
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04034342
- Acronym / sponsor ID
- 259279
- Conditions
- Exercise, Cerebral Palsy
- Keywords
- RaceRunning;, cardiometabolic health desease risk, functional mobility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Brunel University, University of Gloucestershire, University of Edinburgh
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaceRunningRaceRunning (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. | Other | – |
Primary outcome
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)
10 secondary outcomes
Physical activity
Time frame: Baseline, 12 weeks and 24 weeks
sedentary behaviour
Time frame: Baseline, 12 weeks and 24 weeks
Resting heart rate (beats per min)
Time frame: Baseline, 12 weeks and 24 weeks
Resting heart rate blood pressure (mmHg)
Time frame: Baseline, 12 weeks and 24 weeks
Functional mobility Scale
Time frame: Baseline, 12 weeks and 24 weeks
Muscle strength
Time frame: Baseline, 12 weeks and 24 weeks
calf and waist circumference (mm)
Time frame: Baseline, 12 weeks and 24 weeks
Quality of Life (EQ-5D)
Time frame: Baseline, 12 weeks and 24 weeks
The Canadian Occupational Performance Measure
Time frame: Baseline, 12 weeks and 24 weeks
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: Baseline, 12 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 32611743Ryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta L van der Linden, PhD principal investigator
Queen Margaret University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Cerebral Palsy, run by Queen Margaret University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marietta van der Linden, PhD (0131 4740000, mvanderlinden@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum aerobic capacity (VO2max) (time frame: Baseline, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.