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

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV Wasting Syndrome, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
megestrol
Exercise
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring disease-related problem/condition, human immunodeficiency virus infection, immunologic disorders and infectious disorders, nutrition, rare disease, viral infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004664
    Brief Title
    Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Northwestern University

    4. Oversight

    5. 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    69 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    megestrol
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jamie Hayden Von Roenn
    Organizational Affiliation
    Northwestern University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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