Exercise and Weight Loss in PAD (Action3)

VA Office of Research and Development

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Weight Loss; Other: Exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02607033

E1788-W

IK2RX001788-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Exercise and Weight Loss

Experimental group

Description:

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

Treatment:

Other: Exercise

Other: Weight Loss

Exercise

Active Comparator group

Description:

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

Treatment:

Other: Exercise