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

Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231360
• Other study ID #: 2010p001107RP
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2010
• Last updated: February 20, 2013
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2013
• Source: Brigham and Women's Hospital
• Contact: Jessica Milian, BA
• Phone: 617-732-6320
• Email: jmilian[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	American Heart Association, Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of genes regulating skeletal muscle metabolism		3 months	No
Secondary	Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.		3 months	No