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临床试验/NCT05120778
NCT05120778尚未招募不适用

Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.

University of Castilla-La Mancha0 个研究点目标入组 207 人开始时间: 2021年12月1日最近更新:
适应症

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

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.)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

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