Back to resultsThe Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
Primary Purpose
Claudication
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Normal routine
Sponsored by
About this trial
This is an interventional treatment trial for Claudication focused on measuring claudication, peripheral artery disease, PAD
Eligibility 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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exercise Training
Normal routine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Expression of genes regulating skeletal muscle metabolism
Secondary Outcome Measures
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Full Information
NCT ID
NCT01231360
First Posted
October 28, 2010
Last Updated
February 20, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
American Heart Association, Joslin Diabetes Center
1. Study Identification
Unique Protocol Identification Number
NCT01231360
Brief Title
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
Official Title
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
American Heart Association, Joslin Diabetes Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claudication
Keywords
claudication, peripheral artery disease, PAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal routine
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
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 Type
Other
Intervention Name(s)
Normal routine
Intervention Description
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 Information:
Title
Expression of genes regulating skeletal muscle metabolism
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Milian, BA
Phone
617-732-6320
Email
jmilian@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reena Pande, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Milian, BA
Phone
617-732-6320
Email
jmilian@partners.org
First Name & Middle Initial & Last Name & Degree
Reena Pande, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
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