ClaudicationNCT01231360
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
A study testing Exercise Training and Normal routine in people with Claudication, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Claudication
- What is being tested?
- Exercise Training and Normal routine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2014
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- claudication symptoms
- ABI ≤ 0.9 in the symptomatic leg
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jessica Milian, BA, 617-732-6320, jmilian@partners.org
Reena Pande, MD
About this study
Official title: 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.
- Conditions
- Claudication
- Being tested
- Exercise Training, Normal routine
- Keywords
- claudication, peripheral artery disease, PAD
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
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 routineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Active comparator | 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. Receives: Other: Exercise Training |
| Normal routine | Active comparator | 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. Receives: Other: Normal routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of genes regulating skeletal muscle metabolism
Measured: 3 months
Secondary outcomes (1)
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaudicationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Joslin Diabetes Center
- Responsible party
- Principal investigator, Reena Pande, MD, Brigham and Women's Hospital
- Investigators
- Reena Pande, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231360
- Sponsor's protocol ID
- 2010p001107RP
- Status last verified
- Feb 2013
- First submitted
- 28 Oct 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No