Evaluating an Exercise Program to Reduce Cardiovascular Risk Factors in Children Infected With HIV
Atherosclerotic Risk and Response to Exercise Intervention in HIV+ Children
2 other identifiers
interventional
16
1 country
1
Brief Summary
People infected with HIV are now living longer lives because of the use of highly active antiretroviral therapy (HAART). However, HAART medications have been shown to increase the risk of cardiovascular disease and metabolic dysfunction in adults. More research is needed on the effect of HAART in children. The purpose of this study is to assess cardiovascular risk factors in children infected with HIV who receive HAART medications and to determine the effectiveness of an exercise program on cardiovascular outcomes in these children.
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
Started Dec 2008
Longer than P75 for not_applicable hiv
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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 7, 2015
December 1, 2015
6.9 years
May 22, 2009
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
E-selectin, vascular cell adhesion molecule-1 (VCAM-1), P-selectin, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and monocyte chemoattractant protein-1 (MCP-1)
Measured at Year 3
High sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), adiponectin, leptin, mitochondrial DNA (mtDNA), echocardiography, flow-mediated dilation (FMD), and carotid intima-media thickness (cIMT)
Measured at Year 3
Body mass index (BMI), dual energy x-ray absorptiometry (DXA), bioelectrical impedance analysis (BIA), resting energy expenditure (REE), bone mineral density (BMD), lipid profiles, insulin and glucose strength, and fitness measures
Measured at Year 3
Secondary Outcomes (1)
Age, sex, HIV disease stage, CD4 counts, viral load, and type and length of antiretroviral therapies
Measured at Year 3
Study Arms (2)
Control Group
ACTIVE COMPARATORParticipants will take part in a 12-week control group.
Exercise Program
EXPERIMENTALParticipants will take part in a 12-week exercise program.
Interventions
Participants will exercise in the study exercise laboratory for 1 hour on 2 nonconsecutive days a week for 12 weeks. The program will consist of a warm-up with flexibility exercises, aerobic conditioning, a muscular circuit, and a cool-down period with flexibility training.
Participants will attend group sessions once a week for 12 weeks to watch videos, including some exercise videos, and play games that do not require physical activity.
Eligibility Criteria
You may qualify if:
- HIV-Infected Children:
- Must be between 2 weeks and 25 years old with known perinatally acquired HIV infection
- Stable medical regimen for at least 3 months before study entry
- Has not used antihypertensive, hypoglycemic, or lipid-lowering medications
- Active opportunistic infection in the 3 months before study entry
- Willing to participate in the study and sign the informed consent document
- Non-HIV-Infected Siblings/Friends/General Pediatric Control Group:
- Demographically similar to HIV-infected participants
- Not known to be HIV-infected
- Meets all other entry criteria for HIV-infected participants
You may not qualify if:
- Documented diabetes mellitus managed with medications
- Heart, kidney, liver, or muscle disease
- Intercurrent illness at the time of study entry and baseline testing (person can be enrolled when the illness is resolved \[e.g., upper respiratory infection\])
- Must be enrolled in Part 1 of the study
- Must be between 6 and 25 years old
- Willing to participate in the exercise program and sign the informed consent document
- Has medical clearance from physician to participate in the study
- Unable to perform or understand exercise program
- Currently taking medications that would prohibit participation in exercise programs (e.g., coumadin, heparin)
- Heart, kidney, liver, or muscle disease
- Anabolic steroid use in the 3 months before study entry (e.g., growth hormone)
- Malignant arrhythmia
- Has a pacemaker
- Orthopedic problems that would prevent performance of any of the prescribed activities
- Changes in metabolic stress testing that would make the exercise program unsafe, as determined by the reporting cardiologist (i.e., ischemic changes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami, Department of Pediatrics, Division of Clinical Research, Batchelor Children's Research Institute
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracie L. Miller, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 25, 2009
Study Start
December 1, 2008
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12