Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Self-evaluation of negative symptoms (SNS) questionnaire
研究概览
简要总结
Physical activity appears to be a novel and original adjunctive therapeutic approach in the management of patients with schizophrenia. It may help reduce schizophrenic symptoms, act as a pro-cognitive therapy, improve quality of life, and reduce cardiovascular comorbidities. Moreover, some evidence suggests that physical activity practiced in a natural environment has even more positive effects on mental health compared to physical activity carried out indoors or in urban settings. Indeed, greater exposure to greenery is associated with a better perception of general health and with reduced levels of cortisol, anxiety, and depression. No study has yet attempted to examine the impact of physical activity in green (outdoor) spaces compared to indoor physical activity on the negative symptoms of patients suffering from schizophrenia. The aim of this study is therefore to test this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with schizophrenia, aged 18 to 55 years
- •Having persistent negative symptoms (SNS), negative symptoms self-assessment scale > 7
- •Regularly monitored in the psychiatry department.
- •Have no medical contraindications to physical activity
- •Subject affiliated with or entitled to a social security system.
- •Subject having received informed information about the study and having co-signed, with the investigator, consent to participate in the study.
- •Male or female.
排除标准
- •Patient unsuitable for study in the opinion of the investigator
- •Any subject with chronic joint pathologies (example: repeated sprains, patellar or ligament problems) or cardiac pathologies.
- •Any subject presenting chronic or central neurological pathologies.
- •Any subject deprived of liberty or subject to legal protection
- •Excessive consumption of alcohol (> 14 glasses per week) or caffeinated drinks (> 400 mg of coffee per day).
- •Pregnant women.
- •Subject unable to understand the purpose and conditions of the study, unable to give consent.
研究组 & 干预措施
INT group
8-week indoor physical activity program (in a gymnasium)
干预措施: 8-week indoor physical activity program (Other)
EXT group
8-week outdoor physical activity program
干预措施: 8-week outdoor physical activity program (Other)
TEM group
Without physical activiy program (no change in routine)
结局指标
主要结局
Self-evaluation of negative symptoms (SNS) questionnaire
时间窗: Weeks 2, 10 and 22
The primary outcome will be the evolution of negative symtoms, assessed using the Self-evaluation of negative symptoms (SNS) questionnaire. The total SNS score ranges from 0 to 40, where higher scores indicate greater severity of negative symptoms.
次要结局
- Balance(Weeks 2, 10 and 22.)
- Clinical global Impression (CGI) scale(Weeks 2, 10 and 22)
- Personal and social performance (PSP) scale(Weeks 2, 10 and 22)
- Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)(Weeks 2, 10 and 22.)
- VO2 max(Weeks 2, 10 and 22.)
- Flexibility(Weeks 2, 10 and 22.)
- Maximum force(Weeks 2, 10 and 22.)
- Spatio-temporal coordination(Weeks 2, 10 and 22.)
- IPAQ questionnaire(Weeks 2, 10 and 22.)