Liver transplantation is an accepted therapy for end-stage liver failure and clearly increases physical functioning compared to pre transplant levels, however transplant recipients continue to experience significant limitations in physical functioning and frequently report symptoms related to muscle weakness and fatigue and are at risk for excessive weight gain. Cardiovascular risk is also elevated. Typically patients are followed medically for the functioning of their organ, however little attention and no interventions are incorporated to improve physical fitness or minimize weight gain and cardiovascular risk. In other transplant recipients exercise training increases physical functioning and dietary modification results in improved lipid profiles. No such study has been done in liver transplant recipients. The proposed study is a randomized clinical trial of liver transplant recipients to determine differences in physical fitness, quality of life and cardiovascular risk between groups: Usual Care UC) and an intervention of Exercise Training plus Diet Modification (XD). The interventions will be initiated 3 months after transplant and testing will be done at 3, 6 and 12 months post transplant. The exercise will be individually prescribed for daily independent walking or cycling at home. The dietary intervention will be based on the National Cholesterol Education Project Recommendations with the goal of achieving caloric balance to maintain body weight within ideal body weight plus/minus 10%. Both interventions will be aggressively monitored to maximize adherence using recording logs, regular phone follow-up and regular clinic visits. Primary outcome measures are: 1) measures of physical fitness: a) cardiorespiratory fitness as measured by maximal oxygen uptake; muscle strength as measured by peak torque by isokinetic testing; and body composition (body fat percentage and lean body mass) as measured by dual X-ray absorptiometry; 2) Quality of life/well-being which will be measured using questionnaire based on the Medical Outcomes Study questionnaire; and 3) Cardiovascular Risk Index using an algorithm based on Framingham data. Additionally, clinical measures of transplant function and medications will be monitored to assess the impact of the interventions. Data analysis techniques will test the effectiveness of the intervention as well as determine the relationship of several measured variables to quality of life/well-being. This study is needed to demonstrate the impact of exercise and diet interventions on optimizing physical fitness and quality of life over and above any improvements that may result from the liver transplant alone and to reduce cardiovascular risk following this surgical procedure.
