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临床试验/NCT02214485
NCT02214485已完成不适用

Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
leg extension power

研究概览

简要总结

Objective: To determine the differential effectiveness of integrated care (IC) and lower extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.

Method: The investigators randomize participants at Bei-Hu site from the "Intervention study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial" into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks and 6 months after initiation of the interventions.

Interventions:

  1. IC: Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.
  2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 79 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Interview Version score is 3-6
  • •frailty index ≧ 1 (Cardiovascular Health Study Phenotypical Classification)。

排除标准

  • •age ≧ 80 years
  • •live in the nursing home.
  • •can not speak Chinese,Taiwanese.
  • •communication or hearing disorders affect daily activities.
  • •visual impairment or daily activities affect communication.
  • •another reason can not Communication or finish Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Version
  • •study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Interview [9, 10]Version score is 0-2 and
  • •communication or cognitive impairments affect daily activities(Exclusion 3-Item Recall score is <=1)
  • •can not stand to walk (available walkers) 5 meters, or unsteady gait when walking five meters, it looks fast fall
  • •there is serious risk of suicide (defined as: Suicide risk assessment score> = 6 points)
  • •alcoholism (defined as: the problem of alcoholism Chinese people self-administered screening questionnaire CAGE have two questions (including) above answer is "yes"
  • •long-term epilepsy, brain tumor, brain surgery, schizophrenia or bipolar disorder

研究组 & 干预措施

integrated care (IC)

Experimental

Subjects will receive such care twice weekly for 12 weeks.

干预措施: integrated care (Behavioral)

lower extremity strength training (LEST)

Experimental

Subjects will receive training twice weekly for 12 weeks

干预措施: lower extremity strength training (Behavioral)

结局指标

主要结局

leg extension power

时间窗: changes in 12 weeks

Leg extension power is to be measured at baseline, 12 weeks (after completion of intervention), and 6 months (after completion of the study). Specifically, following warm-up of three submaximal isotonic contractions, each subject was asked to extend his knee through a range of motions from -80 to -10 degrees of knee extension (0° extension being full knee extension without hyperextension) at an initial resistance equal to 25 percent of the subject's body weight. Knee range of motion was determined goniometrically. Following the successful completion of one full repetition, additional resistance of 1 kg, or a multiple thereof, was added. The repetition was repeated until the subject was no longer able to complete one full repetition. The number is the measured leg extension power

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 (1)

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