The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)

Mass General Brigham

Status: Unknown

Conditions: Claudication

Treatments: Other: Normal routine; Other: Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01231360

2010p001107RP

Details and patient eligibility

About

Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism.

Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients with intermittent claudication.

Enrollment: 75 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• claudication symptoms
• ABI ≤ 0.9 in the symptomatic leg

Exclusion criteria

• diabetes
• impaired fasting glucose
• peripheral vascular intervention within the prior six months
• recent unstable angina
• myocardial infarction or stroke within the prior six months
• changes to their HMG-CoA reductase inhibitor (statin)within the past three months
• changes to pentoxifylline and/or cilostazol regimen within the past three months or anticipated to be necessary during the study
• are on Coumadin
• exercise limitations for reasons other than intermittent claudication (such as congestive heart failure, angina, chronic lung disease, or other disorders affecting the limb such as arthritis or neuropathy)
• rest pain or ulcers due to critical limb ischemia
• lower extremity amputation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Exercise Training

Active Comparator group

Description:

Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described. After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade. Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed. The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%. Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.

Treatment:

Other: Exercise Training

Normal routine

Active Comparator group

Description:

Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.

Treatment:

Other: Normal routine