Status:
COMPLETED
Study of Home-Based Resistance and Strength Training in HIV-Infected Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
Lipodystrophy is characterized by increased cardiovascular disease. Limited strategies are available to increase cardiovascular fitness in this population, particularly among women. Progressive aerobi...
Detailed Description
Baseline Testing: Eligible patients will be tested at the General Clinical Research Center (GCRC) of Massachusetts General Hospital or at the GCRC at Massachusetts Institute of Technology (MIT). For w...
Eligibility Criteria
Inclusion
- Subjects with documented HIV infection, by Western blot or ELISA
- Ages 18-60
- Self-report AND physical evidence, as assessed by the investigators, of at least one of the following:
- increased abdominal girth;
- relative loss of fat in the face;
- relative loss of fat in the extremities; \*dorsocervical fat pad;
- relative increased breast size;
- a score greater than or equal to 1.5 on the Lipodystrophy Scale and a waist to hip ratio of greater than or equal to 0.85.
Exclusion
- Pregnant or actively seeking pregnancy
- Breastfeeding
- New opportunistic infection diagnosed within 4 weeks of the study
- Pharmacologic glucocorticoid therapy (\> 7.5 mg Prednisone or its equivalent/day)
- Androgen, growth hormone or Megace within 3 months of study initiation
- New anti-retroviral therapy within 1 month of the study
- SGOT \> 5x normal and/or clinically significant liver disease
- Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
- Hemoglobin (Hgb) \< 8.0g/dL
- Active substance abuse
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00111332
Start Date
November 1 2002
End Date
July 1 2005
Last Update
April 14 2010
Active Locations (1)
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1
Mass General Hospital
Boston, Massachusetts, United States, 02114