Exercise Test and Sequential Training Strategies in PAD

Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease

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 Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: exercise rehabilitation by near-infrared spectrometer

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan, 204
    • Recruiting
    • Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
    • Contact: Tieh Cheng Fu, MD, PhD; Phone Number: 2626 886-2-24313131; Email: mr5598@adm.cgmh.org.tw
    • Principal Investigator: Tieh-Cheng Fu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: exercise training; peripheral arterial disease; local aerobic training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 103-4837B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No