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

Not Applicable

• Conditions: Claudication

• 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

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