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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01231360
Enrollment
75
Registered
2010-11-01
Start date
2010-10-31
Completion date
2014-06-30
Last updated
2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication

Keywords

claudication, peripheral artery disease, PAD

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.

Interventions

OTHERExercise 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.

OTHERNormal 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.

Sponsors

American Heart Association
CollaboratorOTHER
Joslin Diabetes Center
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Expression of genes regulating skeletal muscle metabolism3 months

Secondary

MeasureTime frame
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.3 months

Countries

United States

Contacts

Primary ContactJessica Milian, BA
jmilian@partners.org617-732-6320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026