Anxiety, Depression, Learning Disorders
Conditions
Keywords
exercise medicine, youth, adolescents, students
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.
Interventions
OTHERExercise
Moderate to high intensity physical training
OTHERRelaxation
Low intensity physical activity and relaxation
Sponsors
Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
9 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 : 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 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. |
| 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 |
Countries
Belgium
Contacts
Primary ContactAnne G De Volder, MD, PhD
Backup ContactYannick Bleyenheuft, PhD
Outcome results
None listed