Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 207
- 主要终点
- Change of Annual healthcare cost
研究概览
简要总结
The purpose of this study is to determine if an exercise training intervention together with conventional medical treatment can decrease the annual healthcare cost in patients with metabolic syndrome.
详细描述
It is proposed a multicentral clinical trial with cluster randomization among research nodes located in towns of Castilla-La Mancha and Toledo neighborhoods (Spain). The aim is to compare the annual healthcare cost of patients receiving conventional medical treatment against patients receiving the same intervention plus exercise training for 16 weeks. Exercise training will be based on high-intensity interval training conducted on stationary bikes, and strength training using weight-bearing exercises. Each research node will be composed of the clinical center and the sports facilities available in the town/neighborhood. Research nodes will be randomized into two experimental interventions: i.) conventional medical treatment, and ii.) conventional medical treatment + exercise training. After verbal and written information about the study and related potential risks, all patients fulfilling inclusion criteria will be included after giving written informed consent. At baseline, and after 12 and 24 months, annual healthcare costs will be obtained from the volunteers' clinical records. In addition, at baseline, and after 4, 12, and 24 months, metabolic syndrome components prevalence, metabolic syndrome z-score, body composition, and cardiorespiratory fitness will be tested.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling criteria for metabolic syndrome diagnosis.
排除标准
- •At baseline, engagement to an exercise training program for the last 6 months.
结局指标
主要结局
Change of Annual healthcare cost
时间窗: Baseline, month 12 and 24
From unified medical records, all clinical and paraclinical interventions including pharmacological treatment, diagnostic or therapeutic procedures and primary care and specialized medical consultations will be included
次要结局
- Blood lipids profile(Baseline, month 4,12, and 24.)
- Body composition(Baseline, month 4,12, and 24.)
- Glycemia(Baseline, month 4,12, and 24.)
- Blood pressure(Baseline, month 4,12, and 24.)
- Cardiorespiratory fitness(Baseline, month 4,12, and 24.)
- Central obesity(Baseline, month 4,12, and 24.)
