Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Learning Disorders, Depression, Anxiety

Intervention / Treatment
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* Other: Exercise
* Other: Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two experimental arms: physical training and relaxation program, including social activities. Both programs are conducted in parallel with adolescents and young people. A first study was conducted among schoolchildren and was published. The second study was conducted in a clinical population of Area + -Fond'Roy psychiatric hospital in Brussels. Both studies were performed in a parallel order and randomized at the beginning of the study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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). | Other: Exercise<br>* Moderate to high intensity physical training<br>* Other names: Physical training;|
| Active Comparator: Relaxation<br>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). | Other: Relaxation<br>* Low intensity physical activity and relaxation<br>* Other names: Flexibility training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline psychological well-being as assessed using depression and anxiety questionnaires | Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients | 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, mood and anxiety questionnaires | State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline psychological well-being as assessed using depression questionnaires for children | Children's Depression Inventory (CDI) in french version | 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 | Beck Depression Inventory (BDI-13) in french version | 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 | Self-depression scale (SDS) in french version | 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 | Self-perception profile for children or adolescents in french version | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 
| Change from baseline physical condition : size | Height in meters | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 
| Change from baseline physical condition : weight | Weight in kilograms | 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 | Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2) | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 
| Change from baseline physical condition : body muscle ratio | Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100 | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 
| Change from baseline physical condition : body fat ratio | Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100 | 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 | An estimation of maximal oxygen consumption in field running test (20m-beep test). A submaximal effort test using a cycle ergometer. | 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 | Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime. | 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 | Inhibitory control testing using a go-no go test adapted in E-Prime. | at 3 weeks, at 6 weeks and through study completion, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise medicine, youth, adolescents, students