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

NCT ID: NCT00004664

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-06-30

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.

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.

Conditions

Acquired Immunodeficiency Syndrome; HIV Wasting Syndrome; HIV Infections

Keywords

disease-related problem/condition; human immunodeficiency virus infection; immunologic disorders and infectious disorders; nutrition; rare disease; viral infection

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

megestrol

Intervention Type: DRUG

Exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: lead

Principal Investigators

Jamie Hayden Von Roenn

Role: STUDY_CHAIR

Northwestern University

Other Identifiers

NU-516

Identifier Type: -

Identifier Source: secondary_id

199/11931

Identifier Type: -

Identifier Source: org_study_id