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

NCT ID: NCT02970825

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-11-18

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.

Conditions

Learning Disorders; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Moderate to high intensity physical training

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).

Group Type: ACTIVE_COMPARATOR

Relaxation

Intervention Type: OTHER

Low intensity physical activity and relaxation

Interventions

Exercise

Moderate to high intensity physical training

Intervention Type: OTHER

Relaxation

Low intensity physical activity and relaxation

Intervention Type: OTHER

Other Intervention Names

Physical training; Flexibility training

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Anne G. De Volder, MD, PhD

MD, PhD, Senior Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne G De Volder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

Université catholique de Louvain

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Anne G De Volder, MD, PhD

Role: CONTACT

anne.de.volder@uclouvain.be

+32 2 764 54 82

Yannick Bleyenheuft, PhD

Role: CONTACT

yannick.bleyenheuft@uclouvain.be

Facility Contacts

Anne G De Volder, MD, PhD

Role: primary

anne.de.volder@uclouvain.be

+32 2 764 5482

References

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.

Reference Type: DERIVED

PMID: 31440186 (View on PubMed)

Other Identifiers

Etude 2016/17FEV/060

Identifier Type: -

Identifier Source: org_study_id