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临床试验/NCT03839563
NCT03839563Unknown不适用

Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2019年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
189
试验地点
1
主要终点
Gait characteristics

研究概览

简要总结

The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.

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
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •At least 65 years old
  • •Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
  • •Can ambulate independently
  • •Has mild cognitive impairment

排除标准

  • •Do not live in a community setting
  • •Cannot ambulate independently and communicate with researchers
  • •Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
  • •Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

研究组 & 干预措施

Conventional exercise

Experimental

This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min.

干预措施: Exercise (Behavioral)

Tai chi chuan

Experimental

The 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min.

干预措施: Exercise (Behavioral)

Health education/usual physical activity

No Intervention

After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity.

结局指标

主要结局

Gait characteristics

时间窗: 12 months

Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.

Global cognition

时间窗: 12 months

Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0\~30, with lower scores indicating poorer global cognition.

Serum levels of IGF-1

时间窗: 12 months

Serum IGF-1 concentrations will be assessed.

Serum levels of BDNF

时间窗: 12 months

Serum BDNF concentrations will be assessed.

Serum levels of VEGF

时间窗: 12 months

Serum VEGF concentrations will be assessed.

次要结局

  • Fear of falling(12 months)
  • Falls(12 months)
  • Mobility(12 months)
  • Muscle strength(12 months)
  • Tinetti balance(12 months)
  • Depressive symptoms(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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