Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
Study Details
Study Description
Brief Summary
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).
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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.
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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.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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:
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No acute or untreated infection within 4 weeks prior to entry
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No hospitalization within 2 weeks prior to entry
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No gonadal insufficiency
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No edema
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No pleural effusion
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No uncontrolled diarrhea
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No physical or functional obstruction to food intake
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No physical handicap that would prevent resistance or aerobic exercise
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No cardiac abnormality that would render aerobic exercise a health risk
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No concurrent regular exercise of 3 or more hours a week
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No mental incompetence
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Center for Research Resources (NCRR)
- Northwestern University
Investigators
- Study Chair: Jamie Hayden Von Roenn, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 199/11931
- NU-516