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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
American Heart Association
Joslin Diabetes Center
Information provided by (Responsible Party):
Reena Pande, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01231360
First received: October 28, 2010
Last updated: February 20, 2013
Last verified: February 2013

October 28, 2010
February 20, 2013
October 2010
June 2014   (final data collection date for primary outcome measure)
Expression of genes regulating skeletal muscle metabolism [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01231360 on ClinicalTrials.gov Archive Site
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 ]
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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Claudication
  • 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.
  • 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.
  • 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.
    Intervention: Other: Exercise Training
  • 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.
    Intervention: Other: Normal routine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact: Jessica Milian, BA 617-732-6320 jmilian@partners.org
United States
 
NCT01231360
2010p001107RP
No
Reena Pande, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • American Heart Association
  • Joslin Diabetes Center
Principal Investigator: Reena Pande, MD Brigham and Women's Hospital
Brigham and Women's Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP