Evaluating an Exercise Program to Reduce Cardiovascular Risk Factors in Children Infected With HIV
Acquired Immunodeficiency Syndrome
Behavioral: Exercise Program
Behavioral: Control Group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Atherosclerotic Risk and Response to Exercise Intervention in HIV+ Children|
- 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) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- 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) [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: Yes ]
- Age, sex, HIV disease stage, CD4 counts, viral load, and type and length of antiretroviral therapies [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Control Group
Participants will take part in a 12-week control group.
Behavioral: Control Group
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.
Experimental: Exercise Program
Participants will take part in a 12-week exercise program.
Behavioral: Exercise Program
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.
People infected with HIV are now living longer and healthier lives than HIV-infected people of previous generations because of the widespread use of HAART medications. However, as HIV infection becomes a more chronic illness, rather than a fatal disease, researchers are beginning to identify the long-term complications of HIV infection and its treatment. Adults infected with HIV are increasingly developing the following: hyperlipidemia and dyslipidemia, both of which are associated with high cholesterol levels; endothelial dysfunction; insulin resistance; and changes in body composition, including increased obesity levels and an increase in central body fat. These conditions are all associated with an increased risk of cardiovascular disease. More research is needed to examine how children infected with HIV who are receiving HAART may be affected by these conditions. In this study, researchers will examine children infected with HIV who are receiving HAART (as well as a control group of children who are not infected with HIV) to evaluate vascular function and inflammation over time and how they affect body composition, fat redistribution, insulin resistance, hyperlipidemia, growth, nutrition, bone metabolism, and disease severity. This study will also evaluate the effectiveness of an exercise program on vascular function and cardiovascular outcomes in children infected with HIV who are receiving HAART.
There are two parts to this study. In Part 1, children infected with HIV and their siblings and friends who are not infected with HIV will attend study visits every 6 months for 3 years. At select visits, the following study procedures will occur: medical history review; physical exam; blood collection; body measurements; questionnaires regarding diet, quality of life, and activity levels; and an echocardiogram to obtain images of the heart.
In Part 2 of the study, a portion of participants from Part 1 of the study who are infected with HIV will be randomly assigned to take part in a 12-week exercise program or a control group. At a baseline study visit, all participants will undergo a medical history review, fitness testing, body measurements, muscle and fat measurements, blood collection, echocardiogram, questionnaires to assess quality of life and activity levels, and an ultrasound of the brachial artery (on the upper arm) and carotid artery (on the neck) to measure artery size.
Participants in the exercise program will exercise (e.g., walking, running, cycling, stretching, and weight training) for 1 hour at the study exercise laboratory 2 days a week for 12 weeks. If participants cannot come to the laboratory, they may exercise at home, under the guidance of study researchers. Participants will wear a pedometer on select days and keep an activity log to record how far they walk. At the end of the 12-week program, participants will undergo repeat baseline testing. They will also receive a written, personalized exercise program that they can follow on their own. Participants will receive weekly phone calls from study researchers and will attend study visits once a month for 3 months for follow-up and monitoring. Baseline testing will occur again at the end of the 3-month follow-up period.
Participants in the control group will attend group sessions once a week for 12 weeks at which time they will watch videos, including some exercise videos, and play games that do not require physical activity. At the end of Week 12, participants will undergo repeat baseline testing. They will then have the option of taking part in the exercise program.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908284
|Contact: Gabriel Somarriba, DPTemail@example.com|
|United States, Florida|
|University of Miami, Department of Pediatrics, Division of Clinical Research, Batchelor Children's Research Institute||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Gabriel Somarriba, BS 305-243-4304 firstname.lastname@example.org|
|Contact: Daniela Neri-Almeida, MS, LD, RD 305-243-6117 email@example.com|
|Principal Investigator: Tracie L. Miller, MD|
|Principal Investigator:||Tracie L. Miller, MD||University of Miami|