Aerobic Exercise, Resistance Training and Megestrol Acetate for HIV-Wasting Management
megestrol
+ Exercise
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: June 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.69 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Human immunodeficiency virus seropositive with acquired immune deficiency syndrome Documented weight loss 5% to 15% below ideal weight --Prior/Concurrent Therapy-- No concurrent appetite stimulants At least 6 weeks since initiation of new antiretroviral therapy --Patient Characteristics-- Performance status: Karnofsky 70%-100% Hepatic: No ascites Renal: No nephrosis Other: No acute or untreated infection within 4 weeks prior to entry No hospitalization within 2 weeks prior to entry No gonadal insufficiency No edema No pleural effusion No uncontrolled diarrhea No physical or functional obstruction to food intake No physical handicap that would prevent resistance or aerobic exercise No cardiac abnormality that would render aerobic exercise a health risk No concurrent regular exercise of 3 or more hours a week No mental incompetence