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Exercise and Weight Loss in PAD

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StatusRekrytering
Sponsorer
VA Office of Research and Development

Nyckelord

Abstrakt

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.

Beskrivning

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.

Datum

Senast verifierad: 03/31/2020
Först skickat: 11/12/2015
Beräknad anmälan inlämnad: 11/12/2015
Först publicerad: 11/16/2015
Senaste uppdatering skickad: 04/01/2020
Senaste uppdatering publicerad: 04/05/2020
Faktiskt startdatum för studien: 09/30/2015
Uppskattat primärt slutdatum: 03/31/2021
Beräknat slutfört datum: 03/31/2022

Tillstånd eller sjukdom

Peripheral Arterial Disease

Intervention / behandling

Other: Exercise

Other: Exercise and Weight Loss

Fas

-

Armgrupper

ÄrmIntervention / behandling
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 and 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

Urvalskriterier

Åldrar berättigade till studier 60 Years Till 60 Years
Kön som är berättigade till studierAll
Accepterar friska volontärerJa
Kriterier

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.

Resultat

Primära resultatåtgärder

1. 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

2. 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).

Sekundära resultatåtgärder

1. Difference in Modified Physical Performance Test scores pre-intervention to post-intervention [6 months]

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

2. 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.

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