Depression Clinical Trial
— Move&FGOfficial 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".
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 18, 2021 |
Est. primary completion date | November 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Université catholique de Louvain | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline psychological well-being as assessed using depression and anxiety questionnaires | Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Primary | Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires | State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline psychological well-being as assessed using depression questionnaires for children | Children's Depression Inventory (CDI) in french version | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults | Beck Depression Inventory (BDI-13) in french version | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults | Self-depression scale (SDS) in french version | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline psychological well-being as assessed using self-esteem questionnaires | Self-perception profile for children or adolescents in french version | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition : size | Height in meters | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition : weight | Weight in kilograms | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition as assessed in bioelectrical impedance analysis | Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2) | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition : body muscle ratio | Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100 | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition : body fat ratio | Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100 | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline physical condition as assessed using field running tests or a cycle ergometer | An estimation of maximal oxygen consumption in field running test (20m-beep test).
A submaximal effort test using a cycle ergometer. |
at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control | Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime. | at 3 weeks, at 6 weeks and through study completion, up to 6 months | |
Secondary | Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control | Inhibitory control testing using a go-no go test adapted in E-Prime. | at 3 weeks, at 6 weeks and through study completion, up to 6 months |
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