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

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ClinicalTrials.gov Identifier: NCT02970825
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Anne G. De Volder, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Learning Disorders Depression Anxiety Other: Exercise Other: Relaxation Not Applicable

Detailed Description:
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 (performing a behavioral task such as a Stroop task suited to the subject's age), performed before and after intensive physical training.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 cérébrale, la Cognition et le Bien être Psychologique".
Study Start Date : September 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 aerobic exercise (20 minutes jogging and moderate to high intensity active games) and anaerobic lactic resistance exercise (power training with gymn weights).
Other: Exercise
Moderate to high intensity physical training
Other Name: Physical training

Active Comparator: 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, flexibility training).
Other: Relaxation
Low intensity physical activity and mindfulness
Other Name: Flexibility training




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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).

  12. 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.

  13. 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.



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Ages Eligible for Study:   9 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 severe depression)
  • 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)
  • coagulation disorders
  • severe and unstable asthma
  • history of hearth malformation or heart disease
  • medical conditions prohibiting sport or contraindicating physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970825


Contacts
Contact: Anne G De Volder, MD, PhD +32 2 764 54 82 anne.de.volder@uclouvain.be
Contact: Yannick Bleyenheuft, PhD yannick.bleyenheuft@uclouvain.be

Locations
Belgium
Université catholique de Louvain Recruiting
Brussels, Belgium, 1200
Contact: Anne G De Volder, MD, PhD    +32 2 764 5482    anne.de.volder@uclouvain.be   
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
Principal Investigator: Anne G De Volder, MD, PhD Université Catholique de Louvain

Responsible Party: Anne G. De Volder, MD, PhD, MD, PhD, Senior Research Associate, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02970825     History of Changes
Other Study ID Numbers: Etude 2016/17FEV/060
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.

Keywords provided by Anne G. De Volder, MD, PhD, Université Catholique de Louvain:
exercise medicine
youth
adolescents
students

Additional relevant MeSH terms:
Learning Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders