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

NCT02970825 | Unknown

• 1 other identifier: Etude 2016/17FEV/060
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Learning Disorders; Depression; Anxiety

Keywords

exercise medicine; youth; adolescents; students

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change from baseline psychological well-being as assessed using depression questionnaires for children

  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

  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

  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

  at 3 weeks, at 6 weeks and through study completion, up to 6 months

• Change from baseline physical condition : size

  at 3 weeks, at 6 weeks and through study completion, up to 6 months

Study Arms (2)

Exercise

EXPERIMENTAL

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

Relaxation

ACTIVE COMPARATOR

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

Interventions

Exercise OTHER

Moderate to high intensity physical training

Also known as: Physical training

Exercise

Relaxation OTHER

Low intensity physical activity and relaxation

Also known as: Flexibility training

Relaxation

Eligibility Criteria

• Age: 9 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• involved in education program
• absence of contra-indication of physical activity
• does accept randomization
• no history of neurological illness or brain trauma
• absence of contra-indication to magnetic resonance imaging
• no uncorrected sensory impairment (must understand the therapist)
• absence of conduct disorders (violence, school bullying)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Université catholique de Louvain

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 31440186 DERIVED

MeSH Terms

Conditions

Learning Disabilities; Depression; Anxiety Disorders

Interventions

Exercise; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne G De Volder, MD, PhD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne G De Volder, MD, PhD

CONTACT

+32 2 764 54 82; anne.de.volder@uclouvain.be

Yannick Bleyenheuft, PhD

CONTACT

yannick.bleyenheuft@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Research Associate

Model Details: Two experimental arms: physical training and relaxation program, including social activities. Both programs are conducted in parallel with adolescents and young people. A first study was conducted among schoolchildren and was published. The second study was conducted in a clinical population of Area + -Fond'Roy psychiatric hospital in Brussels. Both studies were performed in a parallel order and randomized at the beginning of the study.

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: November 22, 2016
• Study Start: September 1, 2016
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)