Exercise Test and Sequential Training Strategies in PAD

Study Overview
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Brief Summary
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Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness. In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease. To enhance exercise capacity in patients with PAD may involve redistribution of blood ﬂow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood ﬂow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood ﬂow, and possible increased muscle capillary density and mitochondrial capacity. Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease.

Detailed Description
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Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness. In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease. To enhance exercise capacity in patients with PAD may involve redistribution of blood ﬂow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood ﬂow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood ﬂow, and possible increased muscle capillary density and mitochondrial capacity. Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease

Official Title
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Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: exercise rehabilitation by near-infrared spectrometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankle-brachial index <0.9 Exclusion Criteria: 1.<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications: unstable angina resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg orthostatic blood pressure drop greater than 20 mmHg with symptoms Symptomatic severe aortic stenosis Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise Uncontrolled symptomatic heart failure High-degree atrioventricular blocks Acute myocarditis or pericarditis Acute pulmonary embolus or pulmonary infarction a recent significant change in the resting electrocardiogram suggesting significant ischemia, recent myocardial infarction (within 2 d), or other acute cardiac events

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual training<br>exercise intensity arranged by cardiopulmonary exercise test results | Behavioral: exercise rehabilitation by near-infrared spectrometer<br>* We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer<br>|
| Experimental: Novel exercise training<br>exercise intensity monitor by near-infrared spectrometer | Behavioral: exercise rehabilitation by near-infrared spectrometer<br>* We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical fitness (peak oxygen consumption) | oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test | after 36 session exercise training, up to 12 weeks | 
| physical fitness (exercise duration) | exercise duration in seconds measured during cardiopulmonary exercise test | after 36 session exercise training, up to 12 weeks | 
| physical fitness (walking distance) | walking distance in meters measured during six minutes walking test | after 36 session exercise training, up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, exercise training, local aerobic training