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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety; Learning Disorders
• Intervention / Treatment: Other: Exercise; Other: Relaxation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Université Catholique de Louvain
    • Contact: Anne G De Volder, MD, PhD; Phone Number: +32 2 764 5482; Email: anne.de.volder@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; The experimental, intensive exercise regime will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining structured aerobic exercise (at least 20 minutes jogging and moderate to high intensity active games) and anaerobic lactic resistance exercise (power training with gymn weights).	Other: Exercise; Moderate to high intensity physical training; Other Names: Physical training
Active Comparator: Relaxation; The control activity will include 50-min sessions four times a week during five weeks (for a total of about 17 hours) combining mindfulness, stretching and low intensity active games (breath control, proprioception, walking, social relaxation, flexibility training).	Other: Relaxation; Low intensity physical activity and relaxation; Other Names: Flexibility training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Change from baseline physical condition : size	Height in meters	at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : weight	Weight in kilograms	at 3 weeks, at 6 weeks and through study completion, up to 6 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Anne G De Volder, MD, PhD, Université Catholique de Louvain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): November 18, 2021
• Study Completion (Anticipated): November 18, 2021

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: adolescents; students; youth; exercise medicine
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Learning Disabilities
• Other Study ID Numbers: Etude 2016/17FEV/060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.