Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.
- Conditions
- Learning DisordersAnxietyDepression
- Interventions
- Other: ExerciseOther: Relaxation
- Registration Number
- NCT02970825
- Lead Sponsor
- Université Catholique de Louvain
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise 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). Relaxation 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).
- Primary Outcome Measures
Name Time Method Change from baseline psychological well-being as assessed using depression and anxiety questionnaires 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 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
- Secondary Outcome Measures
Name Time Method Change from baseline physical condition : weight at 3 weeks, at 6 weeks and through study completion, up to 6 months Weight in kilograms
Change from baseline physical condition : body muscle ratio at 3 weeks, at 6 weeks and through study completion, up to 6 months Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100
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 Beck Depression Inventory (BDI-13) in french version
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 Self-perception profile for children or adolescents in french version
Change from baseline physical condition : size at 3 weeks, at 6 weeks and through study completion, up to 6 months Height in meters
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 Children's Depression Inventory (CDI) in french version
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 Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2)
Change from baseline physical condition : body fat ratio at 3 weeks, at 6 weeks and through study completion, up to 6 months Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100
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 An estimation of maximal oxygen consumption in field running test (20m-beep test).
A submaximal effort test using a cycle ergometer.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 Self-depression scale (SDS) in french version
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 Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime.
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 Inhibitory control testing using a go-no go test adapted in E-Prime.
Trial Locations
- Locations (1)
Université catholique de Louvain
🇧🇪Brussels, Belgium