Clinical trial NCT03965520: Exercise Test and Sequential Training Strategies in PAD
Official title: Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
exercise training
local aerobic training
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: physical fitness (peak oxygen consumption)
timeFrame: after 36 session exercise training, up to 12 weeks
measure: physical fitness (exercise duration)
timeFrame: after 36 session exercise training, up to 12 weeks
measure: physical fitness (walking distance)
timeFrame: after 36 session exercise training, up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
Study officials:
References: