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Exercise Test and Sequential Training Strategies in PAD

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise rehabilitation by near-infrared spectrometer
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, exercise training, local aerobic training

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual training

Novel exercise training

Arm Description

exercise intensity arranged by cardiopulmonary exercise test results

exercise intensity monitor by near-infrared spectrometer

Outcomes

Primary Outcome Measures

physical fitness (peak oxygen consumption)
oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
physical fitness (exercise duration)
exercise duration in seconds measured during cardiopulmonary exercise test
physical fitness (walking distance)
walking distance in meters measured during six minutes walking test

Secondary Outcome Measures

Full Information

First Posted
May 17, 2019
Last Updated
May 26, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03965520
Brief Title
Exercise Test and Sequential Training Strategies in PAD
Official Title
Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral arterial disease, exercise training, local aerobic training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual training
Arm Type
Active Comparator
Arm Description
exercise intensity arranged by cardiopulmonary exercise test results
Arm Title
Novel exercise training
Arm Type
Experimental
Arm Description
exercise intensity monitor by near-infrared spectrometer
Intervention Type
Behavioral
Intervention Name(s)
exercise rehabilitation by near-infrared spectrometer
Intervention Description
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
Primary Outcome Measure Information:
Title
physical fitness (peak oxygen consumption)
Description
oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness (exercise duration)
Description
exercise duration in seconds measured during cardiopulmonary exercise test
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness (walking distance)
Description
walking distance in meters measured during six minutes walking test
Time Frame
after 36 session exercise training, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: 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
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tieh Cheng Fu, MD, PhD
Phone
886-2-24313131
Ext
2626
Email
mr5598@adm.cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Tieh-Cheng Fu, MD

12. IPD Sharing Statement

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Exercise Test and Sequential Training Strategies in PAD

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