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The purpose of this PILOT feasibility study is to verify the acceptability, feasibility, and compliance to the DYNAMO-PSY program among young adults treated with antipsychotics for a first episode of psychosis (FEP).
Our hypothesis is that the use of an immersive program of APA, including an EE with VR (connected bikes), will allow good observance to regular physical activity in patients treated with antipsychotics for a FEP. This regular practice of physical activity will prevent the onset of weight gain and metabolic syndrome. In addition, a positive effect on self-esteem, overall and particularly cognitive functioning, quality of life, and adherence to antipsychotic treatment can be expected."
Introduction :
Patients suffering from schizophrenia (SCZ) (1% of the general French population) have an increased risk of cardio-metabolic morbidity and mortality, and their life expectancy is reduced by 15 years. In France, the incidence of psychotic disorders is estimated at 15,000 new cases per year among young people aged 15 to 25 years. Psychotic disorders have a significant socio-economic impact, and the emergence of these disorders represents a real break at the individual, social, and family levels. The first clinical signs of the FEP appear in adolescence or early adulthood, particularly because the brain is more vulnerable during this period to environmental risk factors such as substance use and stress.
Early intervention propose appropriate care from the first symptoms, including the introduction of antipsychotic treatment. However, we know that these treatments can lead to weight gain and metabolic syndrome, a risk factor for cardiovascular disease that can generate treatment discontinuation. Moreover, we know that neurocognitive disorders are predisposing factors not only for the development of early psychosis but also for the chronicity of a psychotic pathology.
Alternative approaches have been developed over the past decades to manage daily difficulties of patients with a FEP (e.g., cognitive issues, symptoms, metabolic syndrome), like a lack of physical activity. Indeed, the relationship between physical exercise and functional improvement has catched the attention of the scientific community, which is testing different approaches in healthy subjects and patients with psychotic disorders. The benefits of physical activity are described in patients with SCZ on weight, metabolic syndrome, and cardiovascular risk ; however, physical activity is too little invested in or quickly abandoned. Adapted physical activity (APA) is particularly indicated in psychiatry, and the benefits of APA in patients with SCZ is proven.
The enriched environment (EE) consists of a set of behavioral interventions to maximize stimulations, which can rely on Virtual Reality (VR) technologies. An immersive, realistic, and attractive environment will increase motivation and observance. Furthermore, the training is safer and more controlled than in outdoor conditions. A research combining EE and VR has used stationary bikes connected to a screen to maintain the physical, cognitive, and social capabilities of elderly subjects. To our knowledge, there are no studies using an EE with VR for the practice of APA in patients suffering from a FEP. However, this EE could lead, with its playful and immersive aspect, to a better observance to APA.
An adapted physical activity program usig connected bike with enriched environment (DYNAMO-PSYProgram) could help to prevent weight gain et metabolic syndrome in a population of First Episode Psychosis patients treated with antipsychotic drugs.
This study is a prospective, monocentric PILOT study. The main objective will be to check that at least 70% of the patients can complete the 20 sessions of the program.
Methods
The treatment being studied involves a program (DYNAMO-PSY) of adapted physical activity with an enriched environment (connected bike, visualized and experienced roads in virtual reality) and supervised, with (on average) two sessions per week, a total of 20 sessions to be completed over a maximum of 15 weeks. The usual hygienic-dietetic care is not modified by the study and consists of the care proposed to patients of the GHU Paris Psychiatry and Neuroscience who have had a first psychotic episode and are treated primarily with medication: clinical and biological monitoring
The visits planned by the experimental protocol include:
The following elements will be collected for all patients at V1 :
The following elements will be collected for all patients at V1 and V2 :
The following cardiometabolic parameters will be recorded at V1 and V2:
Outcomes :
Primary Outcome is to calculate the proportion of patients who fully complete the DYNAMO-PSY program.
It will be measured by the Completion rate : ie. the number of patients who fully complete the DYNAMO-PSY program.
The completition rate to the DYNAMO-PSY program is calculated as the proportion: number of patients who completed the program / number of patients included in the study.
Secondary Outcomes :
Explore the acceptability and compliance to the DYNAMOPSY program, which will be evaluated with :
Explore effect of DYNAMOPSY program on psychiatric symptomes (scores at CAARMS, PANSS, HAD-A, HAD-D, and SNS), cognition (memory with scores at CVLT, number memory, corsi task, executive functions with TMT, fluencies, stroop test, 'test des comissions', BRIEF, attention with score at D2R), general status (self-esteem with WHO-QOL-BREF, quality of life with SOFAS, level of functioning scores with GAF), adhesion to antipsychotic treatment (MARS Scale) between V1 and V2.
Explore the effect of DYNAMOPSY program on cardiometabolic parameters (weight, body mass index, waist circumference, fasting blood glucose concentration, blood triglyceride levels, cholesterol levels, systolic and diastolic levels (HDL, LDL, total), systolic and diastolic blood presure.
Explore the influence of age, sex, sports habits, presence of a dietary follow up, current psychotropic medication, substance use on completing the program.
Statistics :
Statistical analysis will be performed
Sample size :
The sample size was estimated using the confidence interval approach for a proportion (Clopper-Pearson exact test). It is considered that the minimum compliance rate (patients who complete the program/adherent patients) for planning the main study should be at least 70%. Therefore, given the pilot nature of the study, the confidence level (1-alpha) is set at 80% and a bilateral confidence interval equal to 0.18 (CI=0.70-0.88), a necessary sample size of 40 subjects was estimated.
All continuous variables, including changes from baseline, will be summarized with the following statistics:
The following formulas will be used, depending on how the post-baseline endpoint is defined, for each planned visit and for each time point where both baseline and post-baseline values are available:
Baseline characteristics: An initial descriptive analysis will be performed for all collected variables, including :
For all quantitative variables:
For all qualitative variables:
For the evaluation of the primary objective, the percentage of patients who completed the DYNAMO-PSY program according to the protocol will be calculated based on the specified criteria in the primary objective:
• The DYNAMO-PSY program is considered completed when the patient has completed all 20 sessions for a duration of up to 15 weeks.
The hypothesis assumes a non-inferior completion rate of 70%. A 95% confidence interval around the percentage of patients who completed the program will be provided.
Secondary objectives:
For acceptance rate (number of patients accepting the program / number of eligible patients) and compliance rate (number of completed sessions / number of planned sessions), the percentage and 95% confidence interval will be provided.
Regarding the comparison of psychiatric symptoms, general status (self-esteem, quality of life, overall functioning), neurocognition, cardiometamolic parameters before and after the DYNAMO-PSY program, the following exploratory analyses will be conducted:
The influence of age, sex, current psychotropic medication, substance use, dietery follow up, sport habbit on completing the program will be analyzed with chi square tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DYNAMO-PSY program | Experimental | This is a feasibility study. Therfore, there is only one arm, the experimental one, where participants will be enrolled in the DYNAMO-PSY program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted physical activity program involving connected bikes | Other | The treatment being studied involves a program (DYNAMO-PSY) of adapted physical activity with an enriched environment (connected bike, visualized and experienced routes in virtual reality) and is supervised, comprising (on average) two sessions per week, a total of 20 sessions to be completed over a maximum of 15 weeks. Each session will last 60 minutes and will be supervised by a case manager. They will be composed of a warm up, session on the bike (around 30 minutes of bicycling) and stretching. They will take place in an adequate room in the clinical research department of Saint Anne Hospital. The usual hygienic-dietetic care is not modified by the study and consists of the care proposed to patients of the GHU Paris Psychiatry and Neuroscience who have had a first psychotic episode and are treated primarily with medication: clinical and biological monitoring, dietary consultations, therapeutic education group concerning diet and lifestyle. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of the DYNAMO-PSY program | The main objective will be to assess the completion rate of the dynamopsy program. Then, the primary outcome measure will be the completion of the program by the participant (Yes/No). For each patient included in the study, the number of sessions completed will be recorded. The DYNAMO-PSY program consists of 20 sessions in total. The DYNAMO-PSY program is considered completed when the patient has completed 20 sessions (otherwise, the program is considered abandoned). The completion rate to the DYNAMO-PSY program will be calculated as the proportion : number of patients who completed the program / number of patients included in the study. | From enrollment to the end of the program at 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Social and Occupational Functioning | Total score at SOFAS (Social and Occupational Functioning Assessment Scale) | at enrollment and at 15 weeks |
| Global Functionning | Total score at Global Assessment of Functioning (GAF) scale |
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Inclusion Criteria:
- Patient suffering or having suffered from a FEP, corresponding to the criteria of brief psychotic episode or schizoaffective disorder in the DSM-5, within the last two years.
Or suffering from schizophrenia or a schizoaffective disorder, evolving for less than two years.
Exclusion Criteria:
Specific Contraindications to Virtual Reality:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaëlle LEROUX AUGER, DR | Contact | +33 145 652 130 | r.leroux_auger@ghu-paris.fr | |
| ALEXANDRA PHAM, DR | Contact | 01 45 65 83 70 | A.PHAM@ghu-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Raphaëlle LEROUX AUGER, DR | Pôle PEPIT - Centre d évaluation pour Jeunes Adultes et Adolescents (CJAAD) | Principal Investigator |
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|
| at enrollment and at 15 weeks |
| Executive functions - Inhibition | Score at Stroop Test | at the enrollment and at 15 weeks |
| Executive functions : Cognitive flexibility | Score at Trail Making Test | at the enrollment and at 15 weeks |
| Executive functions - symptoms inventory | Composite executive globale Score (CEG) at the BRIEF questionnaire ( Behavior Rating Inventory of Executive Function ). Questionnaire fulfilled by the patient himself. | at the enrollment and at 15 weeks |
| Memory : Digit Span | Total score at Digit Span task | at enrollment and at 15 weeks |
| Memory : visuospatial working memory | Total score at Corsi block - taping task | at enrollment and at 15 weeks |
| Memory : Episodic memory | Total Score at MEM III task | at enrollment and at 15 weeks |
| Memory : Processing speed (visual perception) | Total score at Symbol Search task | at enrollment and at 15 weeks |
| Attention | Total score at D2R task | at enrollment and at 15 weeks |
| Adherence to antipsychotic treatment | Total score at MARS (Medication Adherence Rating Scale) autoquestionnaire | at enrollment and at 15 weeks |
| Weight | Weight (in kg, assessed with a bioimpedance scale) | at enrollment and at 15 weeks |
| Body mass index | Calculated as : weight / height^2 | at enrollment and at 15 weeks |
| waist circumference | in cm, measured with a tape measure | at enrollment and at 15 weeks |
| fasting blood glucose concentration | fasting blood glucose concentration (in mmol/l) | at enrollment and at 15 weeks |
| blood triglyceride levels | blood triglyceride levels (mmol/l) | at enrollment and at 15 weeks |
| Total cholesterol level | Total cholesterol blood level in mmol/L | at enrollment and at 15 weeks |
| HDL cholesterol level | HDL cholesterol blood level in mmol/L | at enrollment and at 15 weeks |
| LDL cholesterol level | LDL cholesterol blood level in mmol/L | at enrollment and at 15 weeks |
| Systolic blood pressure | Systolic blood pressure in mmHg | at enrollment and at 15 weeks |
| diastolic blood pressure | diastolic blood pressure in mmHg | at enrollment and at 15 weeks |
| Quality of life as assessed by WHO-QOL-BREF | Total Score at WHO-QOL-BREF (World Health Organization-Quality Of Life) questionnaire | at enrollment and at 15 weeks |
| Psychotic symptomes as measured with the PANSS | Psychotic symptomes measured with the PANSS (Positive and negative symptomes scale). We will measure three outcomes :
| at the enrollment and at 15 weeks |
| Memory - Verbal Learning | Total score at California Verbal Learning Test (CVLT) | at enrollment and at 15 weeks |
| Executive functions Verbal fluencies | Total score at verbal fluencies task | at the enrollment and at 15 weeks |
| Acceptibility rate of the DYNAMO-PSY program | We will calculate the acceptibility rate as followed : Number of patients included / number of eligible patients | From enrollment to the end of the program at 20 weeks |
| Compliance of participants to the DYNAMO-PSY program | For each participants, we will measure how many sessions have been completed. The compliance rate will be measured as followed : Number of sessions completed by the participant / 20 (number of planned sessions) | From enrollment to the end of the program at 15 weeks |
| Negative psychotic symptoms as measured by SNS | Total score at self evaluation of negative symptoms scale (autoquestionnaire). | at enrollment and at 15 weeks |
| Memory : Number memory | Score at number memory task | at the enrollment and at 15 weeks |
| Executive functions : Planification | Score at the french test -test des comissions- | at the enrollment and at 15 weeks |
| Depression symptomes as measured with HAD-D | Score at the -depression- subscale of the HAD scale (autoquestionnaire) | at enrollment and at 15 weeks |
| Mean duration of the program | For each participants that completed the DYNAMO-PSY program, we will measure time (in days) between the first and the last session (ie the 20th) of the DYNAMOPSY program. We will calculate the mean duration of the program among participants that completed the program. | at the first and at the last session of the DYNAMO-PSY program |
| Anxiety symptoms as measured by HAD-A | Score at anxiety subscale of Hospital anxiety and depression scale (HAD-A) (autoquestionnaire) | at enrollment and at 15 weeks |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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