Effects of a Workplace Health Service Program in Employees With Diagnosed Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Change from baseline in Metabolic Syndrome (MetS) -Z-score
研究概览
简要总结
Hypothesis: An occupational 6 months physical exercise training will lead to better health behaviour and improve the severity of the metabolic syndrome.
312 subjects will be assigned to either an intervention or a waiting-control-group. The intervention group will receive instructions with the aim to perform 150 min exercise training per week. Exercise consists of endurance, strength and coordination training. A feedback system guided by sports scientists will be installed for all subjects in the intervention group using activity monitoring (wearable). After 6 months training subjects from the intervention group will be assigned to one of the following groups for follow-up observation from month 6 to months 12:
- training with personal/individual feedback from sport scientist
- training with automated feedback using activity monitoring Tools (wearable)
- training without further feedback Subjects assigned to the control group will be provided with information on low intensity motion exercises. After 6 months in the control group subjects will be provided with the same exercise intervention as the intervention for a duration of 6 months.
Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at month 24..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
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
- •3 out of 5 parameters of the metabolic syndrome
排除标准
- •ongoing participation in occupational health service
- •clinical relevant acute or chronic infections
- •pregnancy
- •surgery dating back less than 8 weeks
- •artificial joint replacement dating back less than 6 months
- •tumor disease dating back less than 5 years
- •every other disease or relevant functional disorder not allowing to participate in regular physical exercise
结局指标
主要结局
Change from baseline in Metabolic Syndrome (MetS) -Z-score
时间窗: 6 months 12 months, 24 months
Z-Score (arbitrary unit, ranging from -2 to 2), assessed and calculated from the 5 established components of the metabolic syndrome: triglycerides, HDL cholesterol, fasting glucose, waist circumference, and systolic blood pressure.
次要结局
- Change from baseline in Pmax(6 months)
- Change from baseline in Anxiety- and depression severity(6 months, 12 months, 24 months)
- Change from baseline in adherence to training program(6 months, 12 months, 24 months)
- Change from baseline in Work-Ability-Index (WAI)(6 months, 12 months, 24 months)
- Change from baseline in Body weight(6 months)
- Change from baseline in Health-related quality of live: score of SF36 questionnaire(6 months, 12 months, 24 months)
- Change from baseline in body composition(6 months, 12 months, 24 months)