Exercise and Weight Loss in PAD (Action3)

Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Exercise; Other: Weight Loss

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI >25 kg/m2
• Ankle Brachial Index (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Modified Physical Performance Test Post-intervention	A mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Scores from each of the nine items are summed for the total score. Scores are from 0-36 with higher scores considered to be better. The post-testing median score will be reported for post-testing.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Odessa R. Addison, PhD DPT, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimated): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Weight Loss; Mobility Limitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Body Weight; Atherosclerosis; Body Weight Changes; Peripheral Arterial Disease; Peripheral Vascular Diseases; Weight Loss
• Other Study ID Numbers: E1788-W; IK2RX001788-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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