Exercise and Weight Loss in PAD

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Exercise; Other: Weight Loss

• Registration Number: NCT02607033
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Primary Completion: 2022-06-01
• Study Completion: 2023-02-01
• Results First Submitted: 2023-05-05
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Results First Posted: 2024-06-17
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and Weight Loss	Exercise	Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise and Weight Loss	Weight Loss	Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise	Exercise	Individuals assigned to this group will be asked to complete the exercise intervention for xic months

Primary Outcome Measures

Name	Time	Method
Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention	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
Difference in Ankle Brachial Index Pre-intervention to Post-intervention	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). 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.

Secondary Outcome Measures

Name	Time	Method
Score on the Modified Physical Performance Test Post-intervention	6 months	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.
Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention	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.

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States