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

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Northwestern University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004664

Purpose

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.

Condition	Intervention
Acquired Immunodeficiency Syndrome HIV Wasting Syndrome HIV Infections	Drug: megestrol Behavioral: Exercise

MedlinePlus related topics: AIDS Exercise and Physical Fitness

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	69
Study Start Date:	June 1995

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004664

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Northwestern University

Investigators

Study Chair:

Jamie Hayden Von Roenn

Northwestern University

More Information

No publications provided

Study ID Numbers:	199/11931, NU-516
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004664 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

disease-related problem/condition
human immunodeficiency virus infection
immunologic disorders and infectious disorders

nutrition
rare disease
viral infection

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Metabolic Diseases
Antineoplastic Agents, Hormonal
Contraceptive Agents
HIV Wasting Syndrome
Contraceptives, Oral
Acquired Immunodeficiency Syndrome
Contraceptive Agents, Female
Rare Diseases
Central Nervous System Stimulants
Megestrol

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Nutrition Disorders
Wasting Syndrome
Retroviridae Infections
Metabolic Disorder
Appetite Stimulants
Megestrol Acetate

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Contraceptive Agents
Antineoplastic Agents
HIV Wasting Syndrome
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Reproductive Control Agents
Infection
Pathologic Processes
Syndrome
Therapeutic Uses
Contraceptives, Oral, Synthetic
Nutrition Disorders

Retroviridae Infections
Appetite Stimulants
RNA Virus Infections
Disease
Metabolic Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Acquired Immunodeficiency Syndrome
Central Nervous System Stimulants
Megestrol
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 07, 2009