Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004664
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-516 | None | None | None |