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

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

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.

Study Overview

• Status: Unknown
• Conditions: Claudication
• Intervention / Treatment: Other: Exercise Training; Other: Normal routine

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Milian, BA; Phone Number: 617-732-6320; Email: jmilian@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jessica Milian, BA; Phone Number: 617-732-6320; Email: jmilian@partners.org
      • Principal Investigator: Reena Pande, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expression of genes regulating skeletal muscle metabolism	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: American Heart Association; Joslin Diabetes Center
• Investigators: Principal Investigator: Reena Pande, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: PAD; claudication; peripheral artery disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 2010p001107RP