Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Episode of Psychosis
- Conditions
- Schizophrenia; PsychosisSchizo Affective DisorderFirst Episode Psychosis (FEP)
- Registration Number
- NCT06643871
- Lead Sponsor
- Centre Hospitalier St Anne
- Brief Summary
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.\"
- Detailed Description
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:
* a pre-inclusion visit V0, where oral and written information about the study is given to the patient by one of the study investigators
* an inclusion visit = V1 (at least 48 hours after V0, and no more than 15 days later, so that the patient has time to consider participating in the study), with the signing of the informed consent form in the presence of a study investigator.
* an end-of-study visit (= V2), 15 weeks after the inclusion visit V1.
The following elements will be collected for all patients at V1 :
* age, sex at birth, gender
* patients sports habits (weekly physical activity duration, type of physical activity), presence or absence of a dietary follow-up, current psychotropic medication, substance use will also be collected.
The following elements will be collected for all patients at V1 and V2 :
* psychiatric symptomes, with CAARMS, PANSS, HAD-A, HAD-D, SNS, STAI A / B.
* self-esteem measured by Rosenberg self-esteem scale (RSES)
* functional impact with the WHO-QOL-BREF (World Health Organization-Quality Of Life) quality of life questionnaire, the SOFAS, and the general functioning score on the Global Assessment of Functioning (GAF) scale
* cognitive tests : Memory with scores at California Verbal Learning Test (CVLT), digit span, Corsi Block, MEM-III, Executive functions with Trail Making Test (TMT), verbal fluencies, Stroop test, 'test des comissions', autoquestionnaire Behavior Rating Inventory of Executive Function (BRIEF) Processing speed with scores at Coding Test and Symbol search. Attention with score at Symbol Searchn coding D2R task.
* adherence to antipsychotic treatment with the MARS (Medication Adherence Rating Scale) questionnaire.
The following cardiometabolic parameters will be recorded at V1 and V2:
* weight (in kg, assessed with a bioimpedance scale)
* body mass index (weight / height\^2)
* waist circumference (in cm, measured with a tape measure)
* fasting blood glucose concentration (in mmol/l)
* blood triglyceride levels (mmol/l)
* cholesterol levels (total, HDL, LDL)
* systolic and diastolic blood pressure (in mmHg)
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 :
1. Explore the acceptability and compliance to the DYNAMOPSY program, which will be evaluated with :
* Acceptability rate (number of patients accepting the program / number of eligible patients)
* compliance rate (number of sessions completed / number of planned sessions).
* The mean duration of the program.
2. 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.
3. 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.
4. 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:
* Mean
* Standard deviation
* 95% confidence interval
* Median
* Interquartile range (IQR) for asymmetric variables Missing values will be indicated.
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:
* Change from baseline = post-baseline value - baseline value
* Percentage change from baseline = (post-baseline value - baseline value) / baseline value \* 100%
* Ratio to baseline = post-baseline value / baseline value
Baseline characteristics: An initial descriptive analysis will be performed for all collected variables, including :
* For all quantitative variables:
* Absolute, relative, and cumulative frequency
* 95% confidence interval
* Interquartile range
* Indication of missing values
* For all qualitative variables:
* Absolute, relative, and cumulative frequency
* 95% confidence interval
* Indication of missing values
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:
1. 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.
2. 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:
* Quantitative data will be compared between completers and non-completers using Student's t-tests or ANOVA, or non-parametric tests (Wilcoxon, Mann-Whitney, Kruskal-Wallis) if the distribution remains asymmetric even after appropriate transformation (e.g., Tukey's power transformation scale).
* Paired tests will be used for comparing repeated measurements within the same patients.
* Qualitative data will be compared using Chi-squared tests or Fisher's exact tests for independent groups, and McNemar's tests for paired groups (repeated measurements).
3. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- Aged 18 to 30 years.
- Male or female.
- inpatient or outpatient.
- Treated with antipsychotic (typical or atypical).
- Willing to participate in the study and having signed the informed consent form after oral and written information.
- Affiliated or beneficiary of a health insurance scheme.
- Patient not fluent in French.
- Patient in detention or under protective measures.
- Patient hospitalized without consent
- Medical contraindication to cycling (notably ventricular arrhythmia, or prolonged QT interval), validated by a medical opinion.
- Known epilepsy.
- Pregnant or breastfeeding women.
Specific Contraindications to Virtual Reality:
- High susceptibility to motion sickness.
- Vestibular disorders.
- Anomalies in postural statics and/or dynamic balance with proprioception disorders.
- Uncorrected ocular or oculomotor disorders.
- Frequent migraines.
- Severe anxiety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Completion rate of the DYNAMO-PSY program From enrollment to the end of the program at 15 weeks 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.
- Secondary Outcome Measures
Name Time Method Adherence to antipsychotic treatment at enrollment and at 15 weeks Total score at MARS (Medication Adherence Rating Scale) autoquestionnaire
Weight at enrollment and at 15 weeks Weight (in kg, assessed with a bioimpedance scale)
Body mass index at enrollment and at 15 weeks Calculated as : weight / height\^2
waist circumference at enrollment and at 15 weeks in cm, measured with a tape measure
fasting blood glucose concentration at enrollment and at 15 weeks fasting blood glucose concentration (in mmol/l)
blood triglyceride levels at enrollment and at 15 weeks blood triglyceride levels (mmol/l)
Total cholesterol level at enrollment and at 15 weeks Total cholesterol blood level in mmol/L
HDL cholesterol level at enrollment and at 15 weeks HDL cholesterol blood level in mmol/L
LDL cholesterol level at enrollment and at 15 weeks LDL cholesterol blood level in mmol/L
Systolic blood pressure at enrollment and at 15 weeks Systolic blood pressure in mmHg
diastolic blood pressure at enrollment and at 15 weeks diastolic blood pressure in mmHg
Quality of life as assessed by WHO-QOL-BREF at enrollment and at 15 weeks Total Score at WHO-QOL-BREF (World Health Organization-Quality Of Life) questionnaire
Attention at enrollment and at 15 weeks Total score at D2R task
Social and Occupational Functioning at enrollment and at 15 weeks Total score at SOFAS (Social and Occupational Functioning Assessment Scale)
Global Functionning at enrollment and at 15 weeks Total score at Global Assessment of Functioning (GAF) scale
Executive functions - Inhibition at the enrollment and at 15 weeks Score at Stroop Test
Executive functions : Cognitive flexibility at the enrollment and at 15 weeks Score at Trail Making Test
Executive functions - symptoms inventory at the enrollment and at 15 weeks Composite executive globale Score (CEG) at the BRIEF questionnaire ( Behavior Rating Inventory of Executive Function ). Questionnaire fulfilled by the patient himself.
Memory : Digit Span at enrollment and at 15 weeks Total score at Digit Span task
Memory : visuospatial working memory at enrollment and at 15 weeks Total score at Corsi block - taping task
Memory : Episodic memory at enrollment and at 15 weeks Total Score at MEM III task
Memory : Processing speed (visual perception) at enrollment and at 15 weeks Total score at Symbol Search task
Psychotic symptomes as measured with the PANSS at the enrollment and at 15 weeks Psychotic symptomes measured with the PANSS (Positive and negative symptomes scale).
We will measure three outcomes :
* Positive symptomes : total score at the positive symptomes subscale of the PANSS
* Negative symptomes : total score at the positive symptomes subscale of the PANSS
* General symptomes : total score at the general symptomes subscale of the PANSSMemory - Verbal Learning at enrollment and at 15 weeks Total score at California Verbal Learning Test (CVLT)
Executive functions Verbal fluencies at the enrollment and at 15 weeks Total score at verbal fluencies task
Acceptibility rate of the DYNAMO-PSY program From enrollment to the end of the program at 20 weeks We will calculate the acceptibility rate as followed :
Number of patients included / number of eligible patientsCompliance of participants to the DYNAMO-PSY program From enrollment to the end of the program at 15 weeks 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)Negative psychotic symptoms as measured by SNS at enrollment and at 15 weeks Total score at self evaluation of negative symptoms scale (autoquestionnaire).
Memory : Number memory at the enrollment and at 15 weeks Score at number memory task
Executive functions : Planification at the enrollment and at 15 weeks Score at the french test -test des comissions-
Depression symptomes as measured with HAD-D at enrollment and at 15 weeks Score at the -depression- subscale of the HAD scale (autoquestionnaire)
Mean duration of the program at the first and at the last session of the DYNAMO-PSY 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.Anxiety symptoms as measured by HAD-A at enrollment and at 15 weeks Score at anxiety subscale of Hospital anxiety and depression scale (HAD-A) (autoquestionnaire)