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临床试验/NCT02803190
NCT02803190已完成不适用

Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Lower extremety extensor power

研究概览

简要总结

The investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (BMD) maintained with different exercise programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices

详细描述

The current study enrolled subjects who already participated in the 2015 study (n=109) at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in their original integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50) when possible. If target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX for enrollments. New participants are randomized into the ICG and MTG groups. Other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistance training on major muscle groups. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back pain), and spine curve angle (by photography) 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 100 Years(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 extremety extensor power

时间窗: baseline and 12 weeks

Lower extremity extensor power is measured by isokinetic resistance equipment by a tranined research assistant with standarized protocol. We will compare the statistical properties between baseline and after 12 weeks intervention.

次要结局

  • appendicular skeletal muscle index(baseline and 12 weeks)
  • grip strength(baseline and 12 weeks)
  • walking speed(baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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