Clinical trial NCT02607033: Exercise and Weight Loss in PAD
Official title: Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Exercise
Weight Loss
Mobility Limitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-11-17
Enrollment: 18
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention
timeFrame: 6 months
measure: Difference in Ankle Brachial Index Pre-intervention to Post-intervention
timeFrame: 6 months
Secondary outcomes:
measure: Score on the Modified Physical Performance Test Post-intervention
timeFrame: 6 months
measure: Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Odessa R. Addison, PhD DPT
role: PRINCIPAL_INVESTIGATOR
References: