HIV Infections Clinical Trial
OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus
megestrol acetate on lean body mass of patients with human immunodeficiency virus-related
weight loss (HIV-wasting).
II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether
long-term exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency
bioelectrical impedance spectral analysis in measuring body composition.
V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these
therapies on the balance of energy intake and energy expenditure.
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 3 therapy groups: megestrol acetate
alone, exercise plus megestrol acetate, or exercise plus placebo. Therapy continues for 12
weeks.
A single dose of oral megestrol acetate or placebo is administered each morning.
The exercise program consists of aerobic exercise and resistance training performed 3 times
a week under supervision. Hard aerobic exercise is performed for 45 minutes plus a warm-up
and cool-down period; the patient chooses to work on 3 of 5 pieces of exercise equipment.
Exercise intensity is adjusted to a heart rate corresponding to 65% of maximal oxygen
consumption.
Resistance training is done on a universal gym; exercises are designed to work all 6 major
muscle groups. Each exercise is performed at 70% of maximal single repetition resistance.
Resistance is increased 5% when the patient can perform 15 repetitions without failure.
;
Allocation: Randomized, Primary Purpose: Treatment
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