An interventional study of Ischemic Conditioning Low - Sham Comparator and Ischemic Conditioning High - Active Comparator in Peripheral Arterial Disease, Peripheral Vascular Disease and Amputation, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Basic science
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 21 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
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Exclusion Criteria:
Blood flow restriction with low compression
Procedure: Ischemic Conditioning Low - Sham Comparator
Blood flow restriction with high compression
Procedure: Ischemic Conditioning High - Active Comparator
The use of a Hokanson rapid inflator cuff to restrict blood flow at 25mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
The use of a Hokanson rapid inflator cuff to restrict blood flow at 225mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
Change in quadriceps strength
Quadriceps strength assessed by a Biodex dynamometer
Time frame: through study completion, an average of 6 weeks
Change in gait kinematics
Gait mechanics assessed by joint angles using Vicon cameras and reflective markers
Time frame: through study completion, an average of 6 weeks
Change in gait kinetics
Gait mechanics assessed by joint forces using a Bertec instrumented treadmill in combination with gait kinematics
Time frame: through study completion, an average of 6 weeks
Change in gait metabolics
Assessment of oxygen consumption during walking using a metabolic cart
Time frame: through study completion, an average of 6 weeks
Six-minute walk test
Measurement of distance walked in six minutes
Time frame: through study completion, an average of 6 weeks
Plan to share: No
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University of Illinois at Chicago