Elsevier

Contemporary Clinical Trials

Volume 47, March 2016, Pages 315-324
Contemporary Clinical Trials

An exercise-based randomized controlled trial on brain, cognition, physical health and mental health in overweight/obese children (ActiveBrains project): Rationale, design and methods

https://doi.org/10.1016/j.cct.2016.02.007Get rights and content

Abstract

The new and recent advances in neuroelectric and neuroimaging technologies provide a new era for further exploring and understanding how brain and cognition function can be stimulated by environmental factors, such as exercise, and particularly to study whether physical exercise influences brain development in early ages. The present study, namely the ActiveBrains project, aims to examine the effects of a physical exercise programme on brain and cognition, as well as on selected physical and mental health outcomes in overweight/obese children. A total of 100 participants aged 8 to 11 years are randomized into an exercise group (N = 50) or a control group (N = 50). The intervention lasts 20-weeks, with 3–5 sessions per week of 90 min each, and is mainly focused on high-intensity aerobic exercise yet also includes muscle-strengthening exercises. The extent to what the intervention effect remains 8-months after the exercise programme finishes is also studied in a subsample. Brain structure and function and cognitive performance are assessed using structural and functional magnetic resonance imaging and electroencephalographic recordings. Secondary outcomes include physical health outcomes (e.g. physical fitness, body fatness, bone mass and lipid-metabolic factors) and mental health outcomes (e.g. chronic stress indicators and overall behavioural and personality measurements such as anxiety or depression). This project will substantially contribute to the existing knowledge and will have an impact on societies, since early stimulation of brain development might have long lasting consequences on cognitive performance, academic achievement and in the prevention of behavioural problems and the promotion of psychological adjustment and mental health.

Clinical trials. Gov identifier: NCT02295072

Introduction

Over the last years, schools in the USA and in some European countries have received pressure from different entities to reduce the time devoted to physical education in the school curriculum, with the argument that more time spent in traditional and standard academic tasks would result in improvements in academic achievement. Several systematic reviews consistently suggest that this is a wrong assumption. Studies focused on increasing physical education time within the school hours and/or after school time showed no negative effect on academic achievement [1], [2]. In fact, several studies support that regular physical activity might improve brain functioning and cognitive performance, which, in turn, would positively affect academic performance [3], [4], [5]. Recently, another systematic review concluded that overall physical activity is positively related to academic achievement, especially in girls [6]. In line with this, several authors concluded that preadolescent children with better fitness have a better cognition, particularly in the domains of cognition related to executive control [3], [4], [5], but also to learning and memory [7]. They also observed differences in brain functioning, as measured by functional neuroimaging and electrophysiological techniques, and in brain structures, as measured by magnetic resonance imaging (MRI) voxel based morphometry, concluding that fitter children have healthier brains [8], [9], [10].

The prevalence of paediatric obesity has reached epidemic proportions in most of developed and developing countries and it is a major public health problem. In Spain, paediatric obesity is of special concern. According to the data from the World Obesity Federation (www.worldobesity.org), Spain leads the ranking of overweight/obesity in children aged 7–11 years in Europe, together with Malta and Sicily. Moreover, paediatric obesity is linked to a greater risk of several other medical problems. Insulin resistance and other metabolic alterations in childhood have been consistently linked to paediatric obesity, and further studies are still needed to better understand which type of exercise is more efficient in reducing both adiposity and metabolic risk. Osteoporosis and the associated fractures occur later in life and it is a major public health problem. The economic burden of osteoporosis in Europe is higher than any kind of cancer (except lung cancer) or chronic cardiorespiratory diseases [11], [12]. Although the onset of osteoporosis is an adult disease, early prevention remains the most effective public health action. In this context, it has been consistently demonstrated that acquiring a high bone mass pick during childhood and adolescence, which can be largely influenced by exercise, is a key determinant of adult skeletal health [13].

Mental health is a major component of overall health, as defined by the World Health Organization (WHO). A key factor for a healthy mental status is a good management of chronic stress. The current evidence from prospective observational studies, both natural experiments examining real-life stressors and laboratory experiments, shows that stress modifies disease-relevant biological processes in humans. Moreover, experimental studies with animals strongly support a causal link between stress and disease, particularly, depression and cardiovascular disease [14]. Several studies conducted in adults showed that exercise can significantly reduce stress levels. However, the nature of stress in adults and in children is different, and little is known about how exercise might affect stress levels in this age group [15], [16]. Observational evidence suggests that high cardiorespiratory fitness in adulthood predicts lower risk of depression, both in cross-sectional [17] and longitudinal studies [18]. Likewise, adolescents with lower cardiorespiratory fitness level are more likely to be diagnosed of psychosis [19] or schizophrenia [20], [21].

The association between obesity and poor physical and mental health, and the boosting effects of physical exercise on stress and cognition have been established, but there is a dearth of clinical evidence on the impact of exercise interventions on physical and mental health, and there is a need for well-designed randomized controlled trials focused on this topic. The ActiveBrains project will contribute to the understanding of the causal effect of exercise on brain and cognition (primary aim), and also on a relevant set of physical and mental health outcomes (secondary aims).

Section snippets

Design

The ActiveBrains project is an individual randomized controlled trial (1:1) that aims to examine the effects of a 20-weeks physical exercise programme on brain structure and function, cognitive performance, academic achievement and physical and mental health in overweight/obese children. Participants with overweight/obesity, meeting the eligibility criteria, are included in our study. The ActiveBrains project has been approved by the Review Committee for Research Involving Human Subjects at the

Primary outcomes

The full set of primary and secondary outcomes are assessed twice, immediately before and after the 20-weeks exercise programme. A third assessment will be conducted in a subsample (50% of the total sample) 8 months after the intervention finishes.

Discussion

Brain research is considered by many as one of the key challenges of the 21st century (http://www.whitehouse.gov/administration/eop/ostp/grand-challenges). The brain is the most complex organ in the human body, and the cross talk between bodily-based physical activity and brain function is virtually unknown. Existing research has been mostly conducted in animals, and human research is scarce and has recently focused on older adults (e.g. in relation with Alzheimer). There are several studies

Conclusion

Most of current knowledge on brain, cognition and exercise is based on cross-sectional studies and animal models and there is a need for stepping further in the level of evidence and specificity to human brain, by designing and conducting well randomized controlled trials to assess the effect of exercise on brain structure, function, as well as on cognition and physical and mental health. The ActiveBrains project will explore the extent to what exercise is able to improve brain and cognition,

Conflict of interest

The authors declare that they have no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.

Acknowledgements

The ActiveBrains project was funded by the Spanish Ministry of Economy and Competitiveness (Reference DEP2013-47540). FBO and JRR are supported by grant from the Spanish Ministry of Science and Innovation (RYC-2011-09011and RYC-2010-05957, respectively). CC-S and FE-L are supported by grants from the Spanish Ministry of Economy and Competitiveness (BES-2014-068829 and BES-2014-067612, respectively). JM-G is supported by the Spanish Ministry of Education, Culture and Sport (FPU14/06837). This is

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