Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake.
研究概览
简要总结
Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
- •able to carry out long-term exercise.
- •capable of giving informed consent.
排除标准
- •contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) specifications (life threatening or terminal medical conditions; not able to carry out intervention or test procedures; current pregnancy; mothers less than 6 months post-partum).
- •patients under admittance to an acute psychiatric ward.
结局指标
主要结局
Change in peak oxygen uptake.
时间窗: Baseline, 12 weeks, 1 year, 2 years.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.
次要结局
- Quality-adjusted life year(Baseline, 12 weeks, 1 year, 2 years.)
- Hospital stays and contact with health care providers.(Baseline, 1 year, 2 years.)
- Balance(Baseline, 12 weeks, 1 year, 2 years.)
- Stair performance(Baseline, 12 weeks, 1 year, 2 years.)
- Alcohol and substance abuse(Baseline, 12 weeks, 1 year, 2 years.)
- Real world functional behavior(Baseline, 1 year, 2 years.)
- Change in physical activity.(Baseline, 12 weeks, 1 year, 2 years.)
- Clinical symptoms.(Baseline, 1 year, 2 years.)
- Client Satisfaction(Baseline, 12 weeks, 1 year, 2 years.)
- Sit-to-stand test(Baseline, 12 weeks, 1 year, 2 years.)
- Walking performance(Baseline, 12 weeks, 1 year, 2 years.)
- Morning fasting blood levels.(Baseline, 12 weeks, 1 year, 2 years.)
- Tobacco(Baseline, 12 weeks, 1 year, 2 years.)
- Motivation(Baseline, 12 weeks, 1 year, 2 years.)
- Patient activation(Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years)
- Changes in walking economy.(Baseline, 12 weeks, 1 year, 2 years.)
- Functional competence(Baseline,1 year, 2 years.)
- Global functioning(Baseline, 1 year, 2 years.)
- Quality of life.(Baseline, 12 weeks, 1 year, 2 years.)
- Changes in maximal strength.(Baseline, 12 weeks, 1 year, 2 years.)
- Readiness/confidence to change(Baseline, 12 weeks, 1 year, 2 years.)