NCT02517333

Brief Summary

The importance of play and physical activity include its many benefits on positively improving health and well-being, enhancing children's and young people's thinking and performance in school, improving their sleep and enabling confidence and skill building (Janssen and LeBlanc, 2010; Budde et al., 2008; Sallis and Patrick, 1994). However, children with movement difficulties (MD) and physical disabilities are at risk of decreased physical activity and subsequently decreased physical fitness and overall health and well-being as a result. To build upon current findings and to follow-up on a continuing study, looking at the impact (responses) and recovery during and following acute exercise at different intensities in children and adolescents with and without movement difficulties, this next phase aims to provide an intervention to improve fitness levels and health measures and to strategically provide a pathway for longer term participation in physical activity in young people. Implement and evaluate a pathway to sport for 14+ year old young people who do not regularly participate in sport due to Neurodevelopmental conditions, young people presenting with poor coordination and movement, and even children and adolescents with special educational needs. The pathway hopes to promote engagement, participation, inclusion and confidence (EPIC) in sport within local schools and the community through 1) targeted recruitment, 2) confidence and skill building (EPIC Club), 3) connection to sport ('Have a go days') and 4) exit to long term participation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

4.3 years

First QC Date

August 3, 2015

Last Update Submit

April 17, 2018

Conditions

Keywords

Motor skill proficiencymovement difficultiesDevelopmental Coordination Disorder (DCD)Low physical fitness

Outcome Measures

Primary Outcomes (1)

  • Fitness Measures

    Measures are composite and consists of multiple primary outcome measures focused around fitness. Pre- and post-assessments surrounding the EPIC Club gym sessions will seek to monitor changes to fitness measures. The Astrand bike test is a submaximal test of aerobic capacity to predict maximal oxygen uptake based on heart rate and work rate. Arm and leg strength will also be assessed and a motor skill (balance)

    6 weeks

Secondary Outcomes (2)

  • Physical activity questionnaire (PAQ-A) and Child Health Utility (9D) Questionnaire

    6 weeks

  • Adherence

    6 weeks

Study Arms (1)

Proof-of-principle (PoP)

OTHER

Proof-of-principle phase of the study. All participants undergo the exercise intervention as part of the feasibility. 1. Screen within Year 9 Class 2. Targeted recruitment for those scoring in bottom 5th percentile 3. Invite students to take part in 6-week intervention 4. Enroll students participating 5. Pre-intervention assessment 6. Start 6-week Epic Club gym intervention (1-2 times weekly for 45-60 mins) consisting of 30 min cardiovascular exercise and 25-30 min strength/resistance and weight training 7. Post-intervention assessment 8. Exit to longer-term sport/physical activity

Other: EPIC Club

Interventions

Weekly exercise gym sessions (1-2 times weekly) for 45-60 mins each session. Participants will start with a warm-up of 30 mins cardiovascular training either doing cycling, treadmill running or cross-training. The remainder of the session consists of strength/resistance and weight-training involving leg press, leg extensor, pull downs, kettle bells, dumbbells. Gym sessions aim to involve bursts of high-intensity and monitoring of heart rate (potentially with wrist activity monitors with heart rate monitoring and accelerometers) to identify level of physical activity intensity. Participants will also have the opportunity to engage in 'Have a go' sports days run by the Oxfordshire Sports Partnership.

Proof-of-principle (PoP)

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants must be able to walk with or without support for at least 5 meters, be able to safely take part in two-step instructions.
  • GP approval will only be required prior to participation in the training intervention and the assessments if parent/guardian requests so or if the investigators feel there is a need for medical clearance for the child/adolescent to safely participant.
  • The participant should be able to mount the cycle ergometer with or without assistance

You may not qualify if:

  • Any behavioral issues that would prevent safe participation or may put the participant, investigators and others at risk
  • Any contraindications to perform maximal exercise
  • Individuals suffering from muscular degenerative conditions or with uncontrolled medical conditions (e.g. asthma, diabetes, epilepsy- must be stable and on medication for greater than 12 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cherwell School

Oxford, OX2 7EE, United Kingdom

Location

CLEAR Unit

Oxford, OX3 0BP, United Kingdom

Location

Cheney School

Oxford, OX3 7QH, United Kingdom

Location

Wheatley Park School

Oxford, OX33 1QH, United Kingdom

Location

The Oxford Academy

Oxford, OX4 6JZ, United Kingdom

Location

Related Publications (1)

  • Weedon BD, Liu F, Mahmoud W, Metz R, Beunder K, Delextrat A, Morris MG, Esser P, Collett J, Meaney A, Howells K, Dawes H. The relationship of gross upper and lower limb motor competence to measures of health and fitness in adolescents aged 13-14 years. BMJ Open Sport Exerc Med. 2018 Mar 8;4(1):e000288. doi: 10.1136/bmjsem-2017-000288. eCollection 2018.

MeSH Terms

Conditions

ApraxiasMotor Skills Disorders

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Helen Dawes, Professor

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 7, 2015

Study Start

March 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations