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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02970825
Other study ID # Etude 2016/17FEV/060
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date November 18, 2021

Study information

Verified date October 2020
Source Université Catholique de Louvain
Contact Anne G De Volder, MD, PhD
Phone +32 2 764 54 82
Email anne.de.volder@uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Moderate to high intensity physical training
Relaxation
Low intensity physical activity and relaxation

Locations

Country Name City State
Belgium Université catholique de Louvain Brussels

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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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