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Exercise Test and Sequential Training Strategies in PAD

Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03965520
Enrollment
100
Registered
2019-05-29
Start date
2018-04-01
Completion date
2019-12-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease, exercise training, local aerobic training

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

Interventions

BEHAVIORALexercise rehabilitation by near-infrared spectrometer

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
physical fitness (peak oxygen consumption)after 36 session exercise training, up to 12 weeksoxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
physical fitness (exercise duration)after 36 session exercise training, up to 12 weeksexercise duration in seconds measured during cardiopulmonary exercise test
physical fitness (walking distance)after 36 session exercise training, up to 12 weekswalking distance in meters measured during six minutes walking test

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026