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

Primary Purpose

Learning Disorders, Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise
Relaxation
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Learning Disorders focused on measuring exercise medicine, youth, adolescents, students

Eligibility Criteria

9 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Université catholique de LouvainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Relaxation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change from baseline psychological well-being as assessed using depression questionnaires for children
Children's Depression Inventory (CDI) in french version
Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults
Beck Depression Inventory (BDI-13) in french version
Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults
Self-depression scale (SDS) in french version
Change from baseline psychological well-being as assessed using self-esteem questionnaires
Self-perception profile for children or adolescents in french version
Change from baseline physical condition : size
Height in meters
Change from baseline physical condition : weight
Weight in kilograms
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)
Change from baseline physical condition : body muscle ratio
Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100
Change from baseline physical condition : body fat ratio
Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100
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.
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.
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.

Full Information

First Posted
October 9, 2016
Last Updated
October 16, 2020
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02970825
Brief Title
Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.
Acronym
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".
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 18, 2021 (Anticipated)
Study Completion Date
November 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disorders, Depression, Anxiety
Keywords
exercise medicine, youth, adolescents, students

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Relaxation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Physical training
Intervention Description
Moderate to high intensity physical training
Intervention Type
Other
Intervention Name(s)
Relaxation
Other Intervention Name(s)
Flexibility training
Intervention Description
Low intensity physical activity and relaxation
Primary Outcome Measure Information:
Title
Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
Description
Hospital Anxiety Depression Scale (HADS) in french version for all participants, mainly suitable for inpatients
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline psychological well-being as assessed using self-esteem, mood and anxiety questionnaires
Description
State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Secondary Outcome Measure Information:
Title
Change from baseline psychological well-being as assessed using depression questionnaires for children
Description
Children's Depression Inventory (CDI) in french version
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline psychological well-being as assessed using depression questionnaires for adolescents and adults
Description
Beck Depression Inventory (BDI-13) in french version
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline psychological well-being as assessed using depression questionnaire for young people and adults
Description
Self-depression scale (SDS) in french version
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline psychological well-being as assessed using self-esteem questionnaires
Description
Self-perception profile for children or adolescents in french version
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition : size
Description
Height in meters
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition : weight
Description
Weight in kilograms
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition as assessed in bioelectrical impedance analysis
Description
Body mass index (BMI) in kilograms divided by the square of the height in meters (kg/m2)
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition : body muscle ratio
Description
Body muscle percentage : {body muscle mass (kg) / total body mass (kg)} x 100
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition : body fat ratio
Description
Body fat percentage : {body fat mass (kg) / total body mass (kg)} x 100
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline physical condition as assessed using field running tests or a cycle ergometer
Description
An estimation of maximal oxygen consumption in field running test (20m-beep test). A submaximal effort test using a cycle ergometer.
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline cognitive function as assessed using computerized neuropsychological testing of cognitive control
Description
Attention and conflict resolution testing using a variant of the Eriksen Flanker task, adapted for age, in E-Prime.
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months
Title
Change from baseline cognitive function as assessed using computerized neuropsychological testing of inhibitory control
Description
Inhibitory control testing using a go-no go test adapted in E-Prime.
Time Frame
at 3 weeks, at 6 weeks and through study completion, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne G De Volder, MD, PhD
Phone
+32 2 764 54 82
Email
anne.de.volder@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick Bleyenheuft, PhD
Email
yannick.bleyenheuft@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne G De Volder, MD, PhD
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne G De Volder, MD, PhD
Phone
+32 2 764 5482
Email
anne.de.volder@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.
Citations:
PubMed Identifier
31440186
Citation
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.
Results Reference
derived

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

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