Exercise Test and Sequential Training Strategies in PAD

Chang Gung Medical Foundation

Status: Unknown

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: exercise rehabilitation by near-infrared spectrometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03965520

103-4837B

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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:

  1. unstable angina
  2. resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
  3. orthostatic blood pressure drop greater than 20 mmHg with symptoms
  4. Symptomatic severe aortic stenosis
  5. Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
  6. Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
  7. Uncontrolled symptomatic heart failure
  8. High-degree atrioventricular blocks
  9. Acute myocarditis or pericarditis
  10. Acute pulmonary embolus or pulmonary infarction
  11. a recent significant change in the resting electrocardiogram suggesting significant ischemia,
  12. recent myocardial infarction (within 2 d), or other acute cardiac events

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

usual training

Active Comparator group

Description:

exercise intensity arranged by cardiopulmonary exercise test results

Treatment:

Behavioral: exercise rehabilitation by near-infrared spectrometer

Novel exercise training

Experimental group

Description:

exercise intensity monitor by near-infrared spectrometer

Treatment:

Behavioral: exercise rehabilitation by near-infrared spectrometer