Exercise Test and Sequential Training Strategies in PAD

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Behavioral: exercise rehabilitation by near-infrared spectrometer

• Registration Number: NCT03965520
• Lead Sponsor: Chang Gung Memorial Hospital

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

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-26
• Last Update Submitted: 2019-05-26
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel exercise training	exercise rehabilitation by near-infrared spectrometer	exercise intensity monitor by near-infrared spectrometer
usual training	exercise rehabilitation by near-infrared spectrometer	exercise intensity arranged by cardiopulmonary exercise test results

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital; 🇨🇳 Keelung, Taiwan