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

Not Applicable

• Conditions: Claudication
• Interventions: Other: Exercise Training; Other: Normal routine

• Registration Number: NCT01231360
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-11-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-22
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise Training	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.
Normal routine	Normal routine	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.

Primary Outcome Measures

Name	Time	Method
Expression of genes regulating skeletal muscle metabolism	3 months

Secondary Outcome Measures

Name	Time	Method
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.	3 months

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States