Effects of Remote Limb Ischemic Conditioning to Enhance Performance, Cognitive-motor Learning and Muscle Strength in Healthy Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- One-repetition Maximum of Wrist Extensors
研究概览
简要总结
The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can enhance learning of a motor (balance) and an ecologically valid, complex cognitive-motor (driving) task, and increase skeletal muscle strength in neurologically-intact young 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 current study extends that work to determine if RLIC enhances muscle strength training and a complex cognitive-motor task (simulated driving). This Phase I study will yield the necessary information to design and execute subsequent trials in neurologic patient populations.
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 group assignment (RLIC vs. Sham conditioning).
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between the age of 18 and 40 years
- •Visual acuity of 20/20 with corrected vision
排除标准
- •History of neurological condition (i.e. stroke, Alzheimer's disease, Parkinson's disease), Attention Deficit Hyperactivity Disorder (ADHD), depression, bipolar disorder, balance impairment, or vestibular disorder
- •History of severe motion sickness, moderate to severe motion sickness or nausea on oculo-motor components of Simulator sickness questionnaire, inability to ride a car, boat, train or airplane due to motion sickness
- •Recent wrist, hand or forearm injury that would currently prevent ability to lift weights
- •History of lower extremity condition, injury, or surgery that would currently impair ability to stand or balance
- •Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC
- •Any cognitive, sensory, or communication problem that would prevent completion of the study
- •History of or current sleep apnea
- •Current intensive weight lifting or interval training exercise
- •Current substance abuse or dependence
- •Unwillingness to travel for all study visits
研究组 & 干预措施
Sham Conditioning
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 1-8.
干预措施: Driving training (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
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 1-8.
干预措施: RLIC (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
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 1-8.
干预措施: Muscle strength training (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
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 1-8.
干预措施: Driving training (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
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 1-8.
干预措施: Balance training (Behavioral)
Sham Conditioning
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 1-8.
干预措施: Sham conditioning (Behavioral)
Sham Conditioning
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 1-8.
干预措施: Muscle strength training (Behavioral)
Sham Conditioning
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 1-8.
干预措施: Balance training (Behavioral)
结局指标
主要结局
One-repetition Maximum of Wrist Extensors
时间窗: Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up
The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement.
次要结局
未报告次要终点
研究者
Catherine E. Lang
Professor
Washington University School of Medicine