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Exercise and Weight Loss in PAD (Action3)

Primary Purpose

Peripheral Arterial Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Weight Loss
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Exercise, Weight Loss, Mobility Limitation

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and Weight Loss

Exercise

Arm Description

Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months

Individuals assigned to this group will be asked to complete the exercise intervention for xic months

Outcomes

Primary Outcome Measures

Difference in time to onset of calf pain (Claudication Onset Time) pre-intervention to post-intervention
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
Difference in ankle brachial index pre-intervention to post-intervention
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

Difference in Modified Physical Performance Test scores pre-intervention to post-intervention
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
Change in muscle composition of the calf muscles pre-intervention to post-intervention
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.

Full Information

First Posted
November 13, 2015
Last Updated
December 9, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02607033
Brief Title
Exercise and Weight Loss in PAD
Acronym
Action3
Official Title
Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Exercise, Weight Loss, Mobility Limitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Weight Loss
Arm Type
Experimental
Arm Description
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Weight Loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in time to onset of calf pain (Claudication Onset Time) pre-intervention to post-intervention
Description
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
Time Frame
6 months
Title
Difference in ankle brachial index pre-intervention to post-intervention
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in Modified Physical Performance Test scores pre-intervention to post-intervention
Description
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
Time Frame
6 months
Title
Change in muscle composition of the calf muscles pre-intervention to post-intervention
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odessa R. Addison, PhD DPT
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Weight Loss in PAD

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