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Exercise Test and Sequential Training Strategies in PAD

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ClinicalTrials.gov Identifier: NCT03965520
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Behavioral: exercise rehabilitation by near-infrared spectrometer Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: usual training
exercise intensity arranged by cardiopulmonary exercise test results
Behavioral: exercise rehabilitation by near-infrared spectrometer
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer

Experimental: Novel exercise training
exercise intensity monitor by near-infrared spectrometer
Behavioral: exercise rehabilitation by near-infrared spectrometer
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer




Primary Outcome Measures :
  1. physical fitness (peak oxygen consumption) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test

  2. physical fitness (exercise duration) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    exercise duration in seconds measured during cardiopulmonary exercise test

  3. physical fitness (walking distance) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    walking distance in meters measured during six minutes walking test



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965520


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital Recruiting
Keelung, Taiwan, 204
Contact: Tieh Cheng Fu, MD, PhD    886-2-24313131 ext 2626    mr5598@adm.cgmh.org.tw   
Principal Investigator: Tieh-Cheng Fu, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03965520    
Other Study ID Numbers: 103-4837B
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
peripheral arterial disease
exercise training
local aerobic training
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases