Learning DisordersMove&FGNCT02970825
Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being.
A study testing Exercise and Relaxation in people with Learning Disorders and Depression, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 9 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disorders, Depression, Anxiety
- What is being tested?
- Exercise and Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Yannick Bleyenheuft, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Université catholique de Louvain
Brussels, 1200
Anne G De Volder, MD, PhD, +32 2 764 5482, anne.de.volder@uclouvain.be
About this study
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".
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.
Read the 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
- Being tested
- Exercise, Relaxation
- Keywords
- exercise medicine, youth, adolescents, students
- Medical subject headings
- Learning Disabilities, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Physical training
Moderate to high intensity physical training
RelaxationOther
Also called Flexibility training
Low intensity physical activity and relaxation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Children's Depression Inventory (CDI) in french version
Measured: 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
Measured: 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
Measured: 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
Measured: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : size
Height in meters
Measured: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : weight
Weight in kilograms
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion18 Nov 2021 (estimated)
- Study completion18 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning DisordersStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne G. De Volder, MD, PhD, Université Catholique de Louvain
- Investigators
- Anne G De Volder, MD, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970825
- Sponsor's protocol ID
- Etude 2016/17FEV/060
- Acronym
- Move&FG
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.
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.
PubMed 31440186
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT02970825
- Acronym / sponsor ID
- Move&FG / Etude 2016/17FEV/060
- Conditions
- Learning Disorders, Depression, Anxiety
- Keywords
- exercise medicine, youth, adolescents, students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 18 Nov 2021 (estimated)
- Study completion
- 18 Nov 2021 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseThe 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). |
| Relaxation | Active comparator | Other: RelaxationThe 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). |
Who may qualify
- Ages
- 9 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Physical trainingModerate to high intensity physical training | Other | Exercise |
| RelaxationAlso: Flexibility trainingLow intensity physical activity and relaxation | Other | Relaxation |
Primary outcome
Change from baseline psychological well-being as assessed using depression and anxiety questionnaires
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
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
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
State-Trait Anxiety Inventory (STAI) in french version for all participants, mainly suitable for outpatients
12 secondary outcomes
Change from baseline psychological well-being as assessed using depression questionnaires for children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : size
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : weight
Time frame: 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
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : body muscle ratio
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Change from baseline physical condition : body fat ratio
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 31440186Philippot 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.
- Individual participant dataSharing planned: No. This is a monocentric study. All individual participant data that allow subject identification will be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Bleyenheuft, PhD contact
Anne G De Volder, MD, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Relaxation in people with Learning Disorders and Depression, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne G De Volder, MD, PhD (+32 2 764 54 82, anne.de.volder@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline psychological well-being as assessed using depression and anxiety questionnaires (time frame: at 3 weeks, at 6 weeks and through study completion, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.