Study of Home-Based Resistance and Strength Training in HIV-Infected Women
Exercise Effects in HIV-Infected Women
2 other identifiers
interventional
40
1 country
1
Brief Summary
Lipodystrophy is characterized by increased cardiovascular disease. Limited strategies are available to increase cardiovascular fitness in this population, particularly among women. Progressive aerobic and resistance training will increase aerobic capacity and improve strength in HIV positive women with lipodystrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Nov 2002
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 19, 2005
CompletedFirst Posted
Study publicly available on registry
May 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedApril 14, 2010
April 1, 2010
May 19, 2005
April 12, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
aerobic fitness
Secondary Outcomes (5)
strength
body composition
lipids
glucose
cardiovascular disease (CVD) risk markers
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mass General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Dolan SE, Frontera W, Librizzi J, Ljungquist K, Juan S, Dorman R, Cole ME, Kanter JR, Grinspoon S. Effects of a supervised home-based aerobic and progressive resistance training regimen in women infected with human immunodeficiency virus: a randomized trial. Arch Intern Med. 2006 Jun 12;166(11):1225-31. doi: 10.1001/archinte.166.11.1225.
PMID: 16772251BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2005
First Posted
May 20, 2005
Study Start
November 1, 2002
Study Completion
July 1, 2005
Last Updated
April 14, 2010
Record last verified: 2010-04