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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 c&

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 Summary: The investigators wish to document the benefit of an intensive 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 depressive symptoms). The participants will be enrolled either in an experimental, intensive 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 (performin
Sponsor: Université Catholique de Louvain

Current Primary Outcome: Change from baseline psychological well-being as assessed using depression, self-esteem and anxiety questionnaires [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]

State-Trait Anxiety Inventory (STAI) in french version


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline psychological well-being as assessed using depression questionnaires for children [ Time Frame: 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 psychological well-being as assessed using depression questionnaires for adolescents and adults [ Time Frame: 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 depression and anxiety questionnaires [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Hospital Anxiety Depression Scale (HADS) in french version
  • Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Self-depression scale (SDS) in french version
  • Change from baseline psychological well-being as assessed using self-esteem questionnaires [ Time Frame: 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 [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Height in meters
  • Change from baseline physical condition : weight [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Weight in kilograms
  • Change from baseline physical condition as assessed in bioelectrical impedance analysis [ Time Frame: 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 muscle ratio [ Time Frame: 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 physical condition : body fat ratio [ Time Frame: 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 [ Time Frame: 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).
  • Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome:

  • Change from baseline psychological well-being as assessed using depression questionnaires for children [ Time Frame: 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 psychological well-being as assessed using depression questionnaires for adolescents and adults [ Time Frame: 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 depression and anxiety questionnaires [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Hospital Anxiety Depression Scale (HADS) in french version
  • Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Self-depression scale (SDS) in french version
  • Change from baseline psychological well-being as assessed using self-esteem questionnaires [ Time Frame: 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 as assessed in biometric data [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Biometric measures : height, weight, body mass index, body muscle percentage, body fat index
  • Change from baseline physical condition as assessed using field running tests [ Time Frame: 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).
  • Change from baseline cognitive function as assessed using computerized neuropsychological tests [ Time Frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months ]
    Computerized neuropsychological tests are used, adapted for age (e.g., attention testing using variants of the Flanker test and a go-no go test adapted in E-Prime).


Information By: Université Catholique de Louvain

Dates:
Date Received: October 9, 2016
Date Started: September 2016
Date Completion: December 2019
Last Updated: May 1, 2017
Last Verified: May 2017