Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02517333 |
| Other study ID # |
140844 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
August 3, 2015 |
| Last updated |
April 17, 2018 |
| Start date |
March 2014 |
| Est. completion date |
June 2018 |
Study information
| Verified date |
April 2018 |
| Source |
Oxford Brookes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
According to the World Health Organization (WHO), physical inactivity is now recognized as
the fourth leading risk factor for global mortality for non-communicable diseases, and
therefore, supports participation in a variety of physical activities including play, games,
sports, planned exercise and resistance training. In accordance, the UK physical activity
guidelines for children and young people (ages 5-18) from the Chief Medical Officer (CMO)
recommends regular participation in moderate to vigorous physical activity (PA) for at least
60 minutes a day to reduce the risk of children developing cardiovascular conditions later in
life. Moreover, the prevalence of neurodevelopmental conditions affecting motor-developmental
skills is believed to affect 5-6% of school-aged children and thus, has led to wide interest
regarding the physical health and well-being of these children and adolescents due to the
lower levels of fitness and participation in PA observed. Participation in PA is often
hampered by the limited motor performance capacity of young people with movement difficulties
(MD). Furthermore, individuals with poorer motor skills and movement difficulties including
Developmental Coordination Disorder (DCD) and cerebral palsy (CP) have reported low energy
levels, muscle fatigue and poor physical tolerance as factors contributing to reduced
enjoyment, tolerance and participation of PA.
As a consequence, research exploring the fitness and PA patterns of children and adolescents
with poor motor proficiency has presented an alarming risk profile for cardiovascular
disease, due to higher percentage of body fat, decreased aerobic capacity, and generally
decreased participation in PA impacting proper development that may persist into adulthood.
Because children with MD are less able to tolerate certain types of exercise and tend to show
lower levels of activity, they are at greater risk of developing secondary disorders
associated with physical inactivity compared to their typically developing aged peers.
Furthermore, although it has been shown that children with MD are willing to push themselves
maximally, many fail to exercise hard enough to tax the cardiovascular system, potentially
due to and contributing to lower exercise tolerance and lower fitness; all playing a role in
a vicious cycle.
Previous work has shown that the condition of a child's muscle strength may be a major
contributing factor to exercise (particularly at an intensity high enough to have a training
effect). Strength is an essential component of motor skill performance and has become a
crucial element incorporated in training interventions. Therefore, developing competence and
confidence to perform resistance strength exercise during the developmental years may have
important long-term implications for health, fitness and sports performance and even more so
for youth with fewer opportunities to do so. In accordance, measures of fitness appear to all
be interconnected, with level of motor skill and impairment shown to be related to the
maximal oxygen consumption or VO2 peak attained and muscular strength. Exploring the
relationships between VO2max and endurance performance in children may provide insights into
the basic role of physiologic fitness in dictating physical capacity and for identifying
appropriate training regimens in youth. Therefore, it is important to gain a comprehensive
picture of the impact of exercise for health and functional measures and to further develop
an understanding of the physiological, psychological and social aspects limiting successful
long-term PA among children with MD. Implementing interventions that not only involve tasks
to improve fitness measures, but also coordination, muscle function and performance, are
essential.
Based on a recent Cochrane intervention review looking at school-based PA programs for
promoting PA and fitness in children and adolescents aged 6-18 years, the authors suggested
that young people exposed to a training intervention spent more time engaged in
moderate-to-vigorous PA (with results across studies ranging from 5 - 45 min more a day),
spent less time watching television (results ranging from five-60 min less each day) and an
improved VO2max (maximal oxygen uptake). However, school-based interventions were not
effective in increasing PA rates among adolescents, or in reducing health and fitness markers
(i.e. blood pressure, blood cholesterol, BMI and heart rate) (Dobbins et al., 2013), possibly
due to insufficient PA intensities. Furthermore, research studying the effects of acute bouts
of exercise on cognition has provided compelling evidence for the influence of exercise on
working memory. Preliminary results from a current study exploring the impact of acute
exercise at high and low exercise intensities is already showing different cognitive
responses between individuals with MD compared to their typically developing (TD) peers.
Although there is evidence citing the positive impact of increasing PA and play on mood and
behaviour, social relationships, sleep, cognition, academic performance and overall
well-being, additional research exploring the development, execution, implementation and
feasibility of pathways to increase participation and long-term PA and training is warranted.
A fitness screening session for a designated year group (i.e. Year 9) will be held at
mainstream schools in Oxfordshire. Those scoring in the bottom quintile on fitness tests
and/or the motor skill assessment during the screening will be invited to take part in a 6
week training programme (EPIC Club). Participants volunteering to take part will need to
attend assessments before and after the training intervention for evaluation of outcome
measures including looking at aerobic fitness level, muscles strength, cognitive function and
questionnaires focused on self-esteem/self-perception. The aims of EPIC Club are to improve
fitness levels, build up confidence and skills and to provide a pathway to sport via 'Have a
go' Sports Taster Days held throughout the year. Steering groups and focus groups will also
be held inviting the participants, parents and coaches to provide feedback on the progress of
the pathway. Moreover, the evaluation of quantitative and qualitative outcome measures needs
to be further addressed.
Aims:
1. To deliver a pathway for longer-term participation in physical activity and sport via 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
2. Evaluation and assessment of pathway progress through quantitative and qualitative
outcome measures (fitness and physical health measures)
3. To explore impact of pathway program on functioning in other domains, such as cognitive
function, performance in school, sleep, self-esteem and social well-being.
Community Benefits:
This study aims to provide a pathway for engagement, participation, inclusion and confidence
(EPIC) in sport in young people who do not regularly participate in physical activity and
sport due to Neurodevelopmental conditions, young people presenting with poor coordination
and movement and/or including individuals with special educational needs. With the rise in
obesity and lower physical activity levels, it is important to provide a feasible and
meaningful way for young individuals to participate in exercise and sport through community
sport activation.
