Adapted Physical Activity Program in a Enriched Environment and Virtual Reality - Connected Bike - for Patients Undergoing Antipsychotic Treatment in the Context of a First Episode of Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Completion rate of the DYNAMO-PSY program
研究概览
简要总结
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."
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Completion rate of the DYNAMO-PSY program
时间窗: 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.
次要结局
- Social and Occupational Functioning(at enrollment and at 15 weeks)
- Global Functionning(at enrollment and at 15 weeks)
- Executive functions - Inhibition(at the enrollment and at 15 weeks)
- Executive functions : Cognitive flexibility(at the enrollment and at 15 weeks)
- Executive functions - symptoms inventory(at the enrollment and at 15 weeks)
- Memory : Digit Span(at enrollment and at 15 weeks)
- Memory : visuospatial working memory(at enrollment and at 15 weeks)
- Memory : Episodic memory(at enrollment and at 15 weeks)
- Memory : Processing speed (visual perception)(at enrollment and at 15 weeks)
- Attention(at enrollment and at 15 weeks)
- Adherence to antipsychotic treatment(at enrollment and at 15 weeks)
- Weight(at enrollment and at 15 weeks)
- Body mass index(at enrollment and at 15 weeks)
- waist circumference(at enrollment and at 15 weeks)
- fasting blood glucose concentration(at enrollment and at 15 weeks)
- blood triglyceride levels(at enrollment and at 15 weeks)
- Total cholesterol level(at enrollment and at 15 weeks)
- HDL cholesterol level(at enrollment and at 15 weeks)
- LDL cholesterol level(at enrollment and at 15 weeks)
- Systolic blood pressure(at enrollment and at 15 weeks)
- diastolic blood pressure(at enrollment and at 15 weeks)
- Quality of life as assessed by WHO-QOL-BREF(at enrollment and at 15 weeks)
- Psychotic symptomes as measured with the PANSS(at the enrollment and at 15 weeks)
- Memory - Verbal Learning(at enrollment and at 15 weeks)
- Executive functions Verbal fluencies(at the enrollment and at 15 weeks)
- Acceptibility rate of the DYNAMO-PSY program(From enrollment to the end of the program at 20 weeks)
- Compliance of participants to the DYNAMO-PSY program(From enrollment to the end of the program at 15 weeks)
- Negative psychotic symptoms as measured by SNS(at enrollment and at 15 weeks)
- Memory : Number memory(at the enrollment and at 15 weeks)
- Executive functions : Planification(at the enrollment and at 15 weeks)
- Depression symptomes as measured with HAD-D(at enrollment and at 15 weeks)
- Mean duration of the program(at the first and at the last session of the DYNAMO-PSY program)
- Anxiety symptoms as measured by HAD-A(at enrollment and at 15 weeks)