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临床试验/NCT05476536
NCT05476536招募中不适用

The Effectiveness of Technology Combined Self-health Management and Home Care Model Improved the Metabolic Diseases, Sarcopenia, and Serum Inflammation and Metabolic Markers Among Middle-aged and Elderly Individuals in the Community

Chang Gung University of Science and Technology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
metabolic syndrome

研究概览

简要总结

The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.

详细描述

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) >150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older adult with age ≥ 40 years
  • community-dwelling
  • no hearing and visual acuity difficulties

排除标准

  • Unconscious
  • Cognitive impairment or dementia

结局指标

主要结局

metabolic syndrome

时间窗: 4 month follow up

changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

body weight

时间窗: 4 month follow up

weight in kilograms

BMI

时间窗: 4 month follow up

weight and height will be combined to report BMI in kg/m\^2

Frailty

时间窗: 4 month follow up

measurement used study of osteoporotic fracture index (SOF).

次要结局

  • physical agility and dynamic balance ability(4 month follow up)
  • short physical performance battery(4 month follow up)
  • upper limb muscle strength(4 month follow up)
  • static balance ability(4 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

研究点 (1)

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