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

NCT01231360 | Unknown

• 1 other identifier: 2010p001107RP
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Claudication

Keywords

claudication; peripheral artery disease; PAD

Outcome Measures

Primary Outcomes (1)

• Expression of genes regulating skeletal muscle metabolism

  3 months

Secondary Outcomes (1)

• Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.

  3 months

Study Arms (2)

Exercise Training

ACTIVE COMPARATOR

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

Normal routine

ACTIVE COMPARATOR

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

Interventions

Exercise Training OTHER

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.

Exercise Training

Normal routine OTHER

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.

Normal routine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• claudication symptoms
• ABI ≤ 0.9 in the symptomatic leg

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Heart Association: collaborator
• Joslin Diabetes Center: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Reena Pande, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Milian, BA

CONTACT

617-732-6320; jmilian@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Harvard Medical School

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

US (1)