Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being. "Effets de l'entraînement Physique Intensif Sur la plasticité cérébrale, la Cognition et le Bien être Psychologique".
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
研究概览
简要总结
The investigators perform a prospective, randomized, clinical study involving students in education with mood disorders and randomized to an intensive exercise program or a control relaxation activity.
详细描述
The investigators wish to document the benefit of an intensive and structured exercise program in youth with the aim to identify the most effective programs that can improve psychological well-being, especially reducing depressive and anxiety symptoms and improving self-esteem. This study targets participants aged 9 to 30 years and included in an education program (from 4th Grade to undergraduate university or college). The investigators propose to perform a prospective, randomized, clinical study involving participants with mood disorders (International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for medical coding: ICD-10-CM F32.9), anxiety (ICD-10-CM F41.9), specific learning disabilities (ADHD hyperactivity (ICD-10-CM F90.2), dyslexia-dyscalculia-dyspraxia (ICD-10-CM F81.0, F81.2, F81.81)) and healthy subjects equally distributed for confounding variables (age, gender, subclinical or clinical depressive symptoms). The participants (ambulatory or inpatients) will be enrolled either in an experimental, intensive and structured aerobic exercise regime or in a active control activity of stretching and relaxation conducted in parallel. The effects of this program will be assessed for i) psychological symptoms, using questionnaires, ii) cognitive function, particularly attention skills and executive functions, in neuropsychological tasks, and iii) physical abilities (through physical testing). To investigate the therapeutic value of exercise in the prevention of depressive and anxiety symptoms and in the treatment of mood disorders in the young student is a necessity imposed by the current outbreak of depression among adolescents and young people at school. To promote the exercise medicine based on the level of evidence in this specific domain, rigorous experimental studies must be performed. Depending on the results, a medical imaging will be proposed to participants at the end of the behavioral study. This will be a functional magnetic resonance imaging in physiological activation condition (performing a behavioral task such as a Stroop task suited to the subject's age), performed before and after intensive physical training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •involved in education program
- •absence of contra-indication of physical activity
- •does accept randomization
- •no history of neurological illness or brain trauma
- •no history of psychiatric illness (exclusion of psychotic symptoms)
- •absence of contra-indication to magnetic resonance imaging
- •no uncorrected sensory impairment (must understand the therapist)
- •absence of conduct disorders (violence, school bullying)
排除标准
- •does not provide informed consent
- •unstable diabetes
- •Body mass index above P95 (or above 30 for adults) (except medical authorization)
- •coagulation disorders
- •severe and unstable asthma
- •history of hearth malformation or heart disease
- •medical conditions prohibiting sport or contraindicating physical activity
研究组 & 干预措施
Exercise
The experimental, intensive exercise regime will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining structured aerobic exercise (at least 20 minutes jogging and moderate to high intensity active games) and anaerobic lactic resistance exercise (power training with gymn weights).
干预措施: Exercise (Other)
Relaxation
The control activity will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining mindfulness, stretching and low intensity active games (breath control, proprioception, walking, social relaxation, flexibility training).
干预措施: Relaxation (Other)
结局指标
主要结局
Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
时间窗: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients
Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires
时间窗: at 3 weeks, at 6 weeks and through study completion, up to 6 months
State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients
次要结局
- Change from baseline physical condition : size(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline physical condition : weight(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline physical condition : body muscle ratio(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline psychological well-being as assessed using self-esteem questionnaires(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline psychological well-being as assessed using depression questionnaires for children(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline physical condition as assessed in bioelectrical impedance analysis(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline physical condition : body fat ratio(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline physical condition as assessed using field running tests or a cycle ergometer(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
- Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control(at 3 weeks, at 6 weeks and through study completion, up to 6 months)
研究者
Anne G. De Volder, MD, PhD
MD, PhD, Senior Research Associate
Université Catholique de Louvain