"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Percentage of patients that will complete the study (Acceptability)
研究概览
简要总结
The primary aim of this project is to establish the acceptability of the PAI (physical activity intervention) to service users by evaluating if participants can be recruited into the study and if they complete the intervention.
Secondary aims are to estimate if, compared with treatment as usual (TAU), the PAI intervention (1) positively impacts on subjects' psychiatric symptoms (2) succeeds in improving cardiovascular fitness performance. In addition, will be considered the impact of the PAI versus TAU on sleep behavior, quality of life, drug consumption, reduces sedentary behaviour and unscheduled readmissions to the department within 30 days and within 7 days after their dismission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of any SMI
- •Meeting any one of the following criteria as determined by a care co-ordinator:
- •At risk for or have type 2 diabetes mellitus
- •In the clinician's view, have a sedentary lifestyle
- •Smoke tobacco
- •Ability to provide informed consent
- •Ability to understand Italian
排除标准
- •under the age of 18
- •not having a diagnosis of SMI
- •be unable to do exercises
- •be unable to give informed consent
结局指标
主要结局
Percentage of patients that will complete the study (Acceptability)
时间窗: 24-26 weeks
to evaluate if participants can be recruited into the study and if they complete the intervention.
次要结局
- Cardiorespiratory Fitness(24-26 weeks)
- Sleep behavior(24-26 weeks)
- Quality of life (QoL)(24-26 weeks)
- Motivation to engage in physical activity(24-26 weeks)
- Self-report sedentary behaviour and physical activity(24-26 weeks)
- Anthropometric measures(24-26 weeks)
- Psychiatric symptoms(24-26 weeks)
- Blood samples(24-26 weeks)
研究者
Paolo Flocco
adjunct professor
University of Roma La Sapienza