Exercise Test and Sequential Training Strategies in PAD

Peripheral Arterial Disease Clinical Trial

Official title:

Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965520
• Other study ID #: 103-4837B
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• exercise rehabilitation by near-infrared spectrometer
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	physical fitness (exercise duration)	exercise duration in seconds measured during cardiopulmonary exercise test	after 36 session exercise training, up to 12 weeks
Primary	physical fitness (walking distance)	walking distance in meters measured during six minutes walking test	after 36 session exercise training, up to 12 weeks