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Clinical Trials/NCT01231360
NCT01231360UnknownNot Applicable

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

Brigham and Women's Hospital2 sites in 1 country75 target enrollmentStarted: October 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
75
Locations
2
Primary Endpoint
Expression of genes regulating skeletal muscle metabolism
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •claudication symptoms
  • •ABI ≤ 0.9 in the symptomatic leg

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Expression of genes regulating skeletal muscle metabolism

Time Frame: 3 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reena Pande, MD

Instructor, Harvard Medical School

Brigham and Women's Hospital

Study Sites (2)

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