Exercise Test and Sequential Training Strategies in PAD

NCT ID: NCT03965520

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-12-31

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

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

usual training

exercise intensity arranged by cardiopulmonary exercise test results

Group Type: ACTIVE_COMPARATOR

exercise rehabilitation by near-infrared spectrometer

Intervention Type: BEHAVIORAL

We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer

Novel exercise training

exercise intensity monitor by near-infrared spectrometer

Group Type: EXPERIMENTAL

exercise rehabilitation by near-infrared spectrometer

Intervention Type: BEHAVIORAL

We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer

Interventions

exercise rehabilitation by near-infrared spectrometer

We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital

Keelung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Tieh Cheng Fu, MD, PhD

Role: primary

mr5598@adm.cgmh.org.tw

886-2-24313131 ext. 2626

Other Identifiers

103-4837B

Identifier Type: -

Identifier Source: org_study_id