Clinical trial NCT02970825: Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Disorders
Depression
Anxiety
Keywords: exercise medicine
youth
adolescents
students
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Secondary outcomes:
measure: Change from baseline psychological well-being as assessed using depression questionnaires for children
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline psychological well-being as assessed using self-esteem questionnaires
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition : size
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition : weight
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition as assessed in bioelectrical impedance analysis
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition : body muscle ratio
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition : body fat ratio
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline physical condition as assessed using field running tests or a cycle ergometer
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
measure: Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control
timeFrame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Université catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Anne G De Volder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Philippot A, Meerschaut A, Danneaux L, Smal G, Bleyenheuft Y, De Volder AG. Impact of Physical Exercise on Symptoms of Depression and Anxiety in Pre-adolescents: A Pilot Randomized Trial. Front Psychol. 2019 Aug 8;10:1820. doi: 10.3389/fpsyg.2019.01820. eCollection 2019.