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Exercise Test and Sequential Training Strategies in PAD

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.


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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2019)
  • 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
  • physical fitness (exercise duration) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    exercise duration in seconds measured during cardiopulmonary exercise test
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Test and Sequential Training Strategies in PAD
Official Title  ICMJE Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Behavioral: exercise rehabilitation by near-infrared spectrometer
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
Study Arms  ICMJE
  • Active Comparator: usual training
    exercise intensity arranged by cardiopulmonary exercise test results
    Intervention: Behavioral: exercise rehabilitation by near-infrared spectrometer
  • Experimental: Novel exercise training
    exercise intensity monitor by near-infrared spectrometer
    Intervention: Behavioral: exercise rehabilitation by near-infrared spectrometer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965520
Other Study ID Numbers  ICMJE 103-4837B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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