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临床试验/NCT03582943
NCT03582943已完成1 期

Effects of Remote Limb Ischemic Conditioning on Motor Learning in Middle-aged and Older Adults

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年10月20日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
82
试验地点
2
主要终点
Change in Balance Score

研究概览

简要总结

The purpose of this research is to determine if the beneficial effects of remote limb ischemic conditioning on learning seen in young adults are found in middle-aged and older adults.

详细描述

Ischemic conditioning is an endogenous phenomenon in which exposing a target organ or tissue to one or more brief episodes of ischemia results in protection of that organ against subsequent ischemia. The effects of ischemic conditioning are not confined within an organ but can be can be transferred from one organ to another, a technique called remote ischemic conditioning. A clinically feasible method for this is remote limb ischemic conditioning (RLIC), where episodes of ischemia and perfusion are induced with a blood pressure cuff placed on the arm.

The overall goal of this line of work is to use ischemic conditioning to enhance learning and outcomes in persons with neurologic injuries. Two previous studies have shown that remote limb ischemic conditioning (RLIC) can enhance learning a motor task in healthy young adults. The next step is to determine which individuals would receive maximum benefit from RLIC before applying these findings to clinical rehabilitation populations such as stroke. Numerous factors, such as age, body mass index (BMI), sex, and cardiovascular comorbidities may influence the response. The current study determines if RLIC can enhance learning in middle-aged and older adults with their burden of co-morbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are masked to their group assignment.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40-80 years old
  • Had sufficient cognitive skills to provide informed consent and actively participate.
  • Exclusion Criteria (determined by self-report):
  • History of a neurological condition, balance impairment, or vestibular disorder.
  • History of attentional disorders (ADD/ADHD) that could affect learning.
  • History of sleep apnea which could confound the effects of RLIC.
  • Presence of lower extremity condition, injury, or surgery that would compromise performance on the balance task.
  • Learning disability, sensory, or communication problem that would prevent completion of the study.
  • History of epilepsy, peripheral vascular disease, or blood diathesis which could contraindicate RLIC.
  • Current intensive weight lifting or interval training exercise which could confound the effects of RLIC.
  • Current substance abuse or dependence.

排除标准

  • 未提供

研究组 & 干预措施

Remote limb ischemic conditioning (RLIC)

Experimental

RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.

干预措施: RLIC (Behavioral)

Remote limb ischemic conditioning (RLIC)

Experimental

RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.

干预措施: Balance training (Behavioral)

Sham conditioning

Sham Comparator

Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.

干预措施: Sham conditioning (Behavioral)

Sham conditioning

Sham Comparator

Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.

干预措施: Balance training (Behavioral)

结局指标

主要结局

Change in Balance Score

时间窗: 1 week

Balance score at the end of training - balance score at baseline, where balance score is the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. Five trials are averaged to form the balance score at each time point.

次要结局

未报告次要终点

研究者

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

Catherine E. Lang

Professor

Washington University School of Medicine

研究点 (2)

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