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临床试验/NCT04937179
NCT04937179已完成不适用

The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects with Peripheral Artery Disease (PAD)

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change in quadriceps strength

研究概览

简要总结

Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing more weight and increased ground reaction forces through the intact limb-which likely contributes to increased metabolic cost of walking. Lack of adequate muscular strength in the lower limb to attenuate these forces places increased stress on the joints, which may be displaced proximally, and may play a role in reported knee and hip pain in the intact limb.

Lower limb muscle weakness following amputation has been well documented. Increasing quadriceps strength is important after an amputation because it is positively correlated with gait speed. Gait speed may also be associated with successful community mobility, which leads to improved quality of life following amputation. Individuals with amputation who resume an active lifestyle are able to maintain strength. However, these individuals represent a minority of persons with lower limb amputation; most individuals report more barriers than motivators to adopt an active lifestyle.

Ischemic conditioning (IC) may strengthen leg muscles and reduce the metabolic cost of activity after amputation. In IC, the limb is exposed to brief, repeated bouts of ischemia (reduced blood flow) immediately followed by reperfusion. IC has been shown to improve muscle performance in healthy and diseased populations. IC has also been used more recently in patients with peripheral artery disease (PAD) as an intervention to improve function, such as walking ability. Acute exposure to IC increases muscle strength and activation, both in healthy, active individuals and in those with severe neuromuscular dysfunction, such as stroke survivors. IC also attenuates muscular fatigue. Increased fatigue resistance at submaximal contraction levels following IC may be due to increased neural activation of skeletal muscle. Changes in neural activation of muscle may be particularly beneficial during cortical reorganization after amputation. Reduced quadriceps fatigue during submaximal activities may also drive changes in gait kinematics, such as increased knee flexion during loading and mid-stance. Exposure to IC may also increase the oxidative properties of skeletal muscle, offering a direct pathway to reduce metabolic cost. Therefore, IC may lead to cellular changes that lower the metabolic cost of activity.

The primary aim of this study is to quantify the benefits of acute and chronic IC on quadriceps strength and walking economy in individuals with PAD and history of lower limb amputation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • 18 years or older
  • Able to ambulate independently without the use of aids (i.e., walking cane)
  • Able to walk at least 10 minutes continuously without stopping
  • History of diagnosed peripheral artery disease.
  • For Amputees: History lower limb unilateral transtibial or transfemoral amputation.

排除标准

  • Inability to give informed consent
  • neurological disorder that affects gait
  • two or more falls within the previous 12 months
  • currently pregnant (or intend to become pregnant while participating in study)
  • history of any condition where fatiguing contractions or resisted leg contractions are contraindicated
  • blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg).
  • history of hypertension
  • history of heart failure
  • Head injury within the previous 6 months
  • Seizure disorder
  • Adverse reaction to ultrasound gel
  • History of thrombosis
  • History of sickle cell trait

结局指标

主要结局

Change in quadriceps strength

时间窗: through study completion, an average of 6 weeks

Quadriceps strength assessed by a Biodex dynamometer

Change in gait kinematics

时间窗: through study completion, an average of 6 weeks

Gait mechanics assessed by joint angles using Vicon cameras and reflective markers

Change in gait metabolics

时间窗: through study completion, an average of 6 weeks

Assessment of oxygen consumption during walking using a metabolic cart

Change in gait kinetics

时间窗: through study completion, an average of 6 weeks

Gait mechanics assessed by joint forces using a Bertec instrumented treadmill in combination with gait kinematics

次要结局

  • Six-minute walk test(through study completion, an average of 6 weeks)

研究者

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

Lindsay Hannigan

Assistant Professor

University of Illinois at Chicago

研究点 (2)

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