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Exercise and Weight Loss in PAD (Action3)

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ClinicalTrials.gov Identifier: NCT02607033
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Exercise Other: Weight Loss Not Applicable

Detailed Description:
Peripheral artery disease (PAD) affects an estimated 12 -15 million adults in the US and an estimated 20% of older Veterans. Those with PAD ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. It is estimated that over 60% of individuals with PAD are overweight or obese. While PAD itself worsens mobility, obesity adds a further functional burden to older adults with PAD. Individuals diagnosed with PAD, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. Studies of older obese adults without PAD have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. While these findings likely translate to older adults with PAD, this hypothesis has yet to be tested. This study is designed to determine whether weight loss and exercise (WL+EX) versus exercise ( EX ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. The investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese Veterans with PAD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and Weight Loss
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Other: Exercise
Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.

Other: Weight Loss
Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.

Active Comparator: Exercise
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Other: Exercise
Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.




Primary Outcome Measures :
  1. Difference in time to onset of calf pain (Claudication Onset Time) pre-intervention to post-intervention [ Time Frame: 6 months ]
    The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention

  2. Difference in ankle brachial index pre-intervention to post-intervention [ Time Frame: 6 months ]
    a change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months).


Secondary Outcome Measures :
  1. Difference in Modified Physical Performance Test scores pre-intervention to post-intervention [ Time Frame: 6 months ]
    A mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Pre-test scores will be compared to post test scores

  2. Change in muscle composition of the calf muscles pre-intervention to post-intervention [ Time Frame: 6 months ]
    A measure of the amount of muscle and fat in the muscle using a CT scan of the legs. Pre-test levels will be compared to post-test levels.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >30 kg/m2
  • ABI <.90
  • Able to participate in a supervised exercise program at the Baltimore VA
  • No current plan for surgical revascularization
  • Claudication or leg symptoms when walking

Exclusion Criteria:

  • Unstable angina or a recent heart attack
  • Active cancer
  • Dementia
  • Current foot or leg ulcers
  • Already exercise 2x/week or more.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607033


Contacts
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Contact: Eric Christensen, MS (410) 605-7000 ext 5431 echristensen@medicine.umaryland.edu
Contact: Coutrney Eberhardt, MS (410) 605-7000 ext 55444 Courtney.Eberhardt@va.gov

Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Eric Christensen, MS    410-605-7000 ext 5431    echristensen@medicine.umaryland.edu   
Contact: Coutrney Eberhardt, MS    (410) 605-7000 ext 55444    Courtney.Eberhardt@va.gov   
Principal Investigator: Odessa R. Addison, DPT PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Odessa R. Addison, DPT PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02607033     History of Changes
Other Study ID Numbers: E1788-W
IK2RX001788-01 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Exercise
Weight Loss
Mobility Limitation

Additional relevant MeSH terms:
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Weight Loss
Peripheral Arterial Disease
Peripheral Vascular Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases