Evaluating an Exercise Program to Reduce Cardiovascular Risk Factors in Children Infected With HIV
Condition: HIV; Acquired Immunodeficiency Syndrome; Cardiovascular Diseases
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Cardiovascular Diseases; Immunologic Deficiency Syndromes
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise Program; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AIDS; Acquired Immune Deficiency Syndrome Virus; Human Immunodeficiency Virus; Exercise Physiology; Endothelial Dysfunction