Exercise Test and Sequential Training Strategies in PAD

NCT03965520 | Unknown DMC

• 1 other identifier: 103-4837B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; exercise training; local aerobic training

Outcome Measures

Primary Outcomes (3)

• 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

• physical fitness (exercise duration)

  exercise duration in seconds measured during cardiopulmonary exercise test

  after 36 session exercise training, up to 12 weeks

• physical fitness (walking distance)

  walking distance in meters measured during six minutes walking test

  after 36 session exercise training, up to 12 weeks

Study Arms (2)

usual training

ACTIVE COMPARATOR

exercise intensity arranged by cardiopulmonary exercise test results

Behavioral: exercise rehabilitation by near-infrared spectrometer

Novel exercise training

EXPERIMENTAL

exercise intensity monitor by near-infrared spectrometer

Behavioral: exercise rehabilitation by near-infrared spectrometer

Interventions

exercise rehabilitation by near-infrared spectrometer BEHAVIORAL

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

Novel exercise training; usual training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle-brachial index \<0.9

You may not qualify if:

• \<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications:
• unstable angina
• resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
• orthostatic blood pressure drop greater than 20 mmHg with symptoms
• Symptomatic severe aortic stenosis
• Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
• Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
• Uncontrolled symptomatic heart failure
• High-degree atrioventricular blocks
• Acute myocarditis or pericarditis
• Acute pulmonary embolus or pulmonary infarction
• a recent significant change in the resting electrocardiogram suggesting significant ischemia,
• recent myocardial infarction (within 2 d), or other acute cardiac events

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Keelung, 204, Taiwan

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 29, 2019
• Study Start: April 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

TW (1)