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

Depression Clinical Trial

— Move&FG  

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".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02970825
• Other study ID #: Etude 2016/17FEV/060
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Learning Disorders

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