This study complements the Intervention Study (IS) by performing a developmental trial in older smokers with disabling peripheral arterial disease (PAD) who were excluded from IS. This was deemed necessary because of the poor compliance of smokers to health promoting behaviors and our need to develop effective interventions for the treatment of PAD in these patients. The goal is to determine the effectiveness of an aggressive risk factor modification program (ARFM) with and without a cognitive-behavioral smoking cessation intervention on functional independence (claudication pain, exercise capacity), cardiovascular disease (CVD) risk factors, psychosocial functioning and health care utilization and expenditures in older smokers with claudication. Smoking is the major risk factor for PAD, followed by diabetes, hypertension, and hyperlipidemia. Exercise training and dietary modification reduce risk factors for CVD, and in patients with PAD they may complement each other to improve functional independence and prevent the progression and complications from atherosclerotic CVD. However, older smokers rarely engage in exercise, eat prudent diets or avoid alcohol; hence, their ability to comply to an ARFM program is suspect. This dysfunctional behavior may be related to the duration and cumulative exposure of older smokers to nicotine, but also could be a manifestation of depression. We hypothesize that in older smokers with PAD, behavioral-related dependencies will limit their ability to comply with and derive clinical, functional, and psychosocial benefits from an ARFM that does not include a supplemental cognitive-behavioral smoking cessation program. Therefore, a randomized clinical trial will determine the effects of an ARFM intervention on functional and exercise capacity, cardiac and peripheral vascular function, risk factors for CVD, health services utilization and cost, and long-term functional independence in older smokers with disabling PAD. The results of this trial will have implications for reducing CVD complications and improving the functional independence of a disabled population of older patients at high risk for CVD-related morbidity and mortality.
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