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临床试验/NCT02483286
NCT02483286已完成不适用

Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2015年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
2
主要终点
Lower extremity extensor power

研究概览

简要总结

OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks.

MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, and coping strategy and another hour of professional led exercise program. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power at baseline and after 12-weeks of intervention.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • older than 50 years of age
  • high risk as defined from one of the following criteria:
  • score>=1 on one minute osteoporosis risk questionnaire
  • 10 year predicted fracture risk >=20% for major osteoporotic fracture or >=3% for hip fracture from FRAX
  • fall>=2 times in pass 1 year
  • having a bone mineral density test within one year period
  • having the capability to understand the study and complete the study interventions
  • willing to participate for the intervention and study follow ups

排除标准

  • People younger than 50 years of age
  • Could not communicate because of hearing, visual, or cognitive problems
  • Unable to stand and walk unaided (walking aids are acceptable)

结局指标

主要结局

Lower extremity extensor power

时间窗: 12 weeks

Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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