Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004664
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001

February 24, 2000
June 23, 2005
June 1995
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Complete list of historical versions of study NCT00004664 on ClinicalTrials.gov Archive Site
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Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
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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.

Interventional
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Allocation: Randomized
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Wasting Syndrome
  • HIV Infections
  • Drug: megestrol
  • Behavioral: Exercise
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004664
199/11931, NU-516
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National Center for Research Resources (NCRR)
Northwestern University
Study Chair: Jamie Hayden Von Roenn Northwestern University
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP