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

Purpose

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.

Condition	Intervention
Claudication	Other: Exercise Training Other: Normal routine

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Expression of genes regulating skeletal muscle metabolism [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	October 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231360

Contacts

Contact: Jessica Milian, BA

617-732-6320

jmilian@partners.org

Locations

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

Sponsors and Collaborators

Brigham and Women's Hospital

American Heart Association

Joslin Diabetes Center

Investigators

Principal Investigator:

Reena Pande, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Reena Pande, MD, Instructor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01231360 History of Changes
Other Study ID Numbers:	2010p001107RP
Study First Received:	October 28, 2010
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

claudication
peripheral artery disease
PAD

Additional relevant MeSH terms:

Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013