Recruiting

Exercise Training

Sponsor:

Brigham and Women's Hospital

Code:

NCT01231360

Conditions

Claudication

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Exercise Training

Normal routine

Study Details

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

Study ID

NCT01231360

Start date

Oct, 2010

Status verified date

Feb, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Expression of genes regulating skeletal muscle metabolism [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jessica Milian, BA

617-732-6320jmilian@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jessica Milian, BA

617-732-6320jmilian@partners.org

Principal Investigator:

Reena Pande, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 22, 2013

Last verified

Feb, 2013

Keywords

  • claudication
  • peripheral artery disease
  • PAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2013-02-22.