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

Université Catholique de Louvain

Status: Unknown

Conditions: Depression; Anxiety; Learning Disorders

Treatments: Other: Relaxation; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02970825

Etude 2016/17FEV/060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 9 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Exercise

Experimental group

Description:

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).

Treatment:

Other: Exercise

Relaxation

Active Comparator group

Description:

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).

Treatment:

Other: Relaxation