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| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004664 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting | ||||
| Official Title ICMJE | |||||
| 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). 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. |
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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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Placebo Control | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 69 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004664 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/11931, NU-516 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Northwestern University | ||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | December 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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