Study of Home-Based Resistance and Strength Training in HIV-Infected Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

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 women with regular menses, the admission will correspond to the early
      follicular phase. Patients will receive a menstrual history calendar to submit at the
      baseline and 16 week visits. A complete history and physical exam will be performed,
      including a detailed history of all drugs being used in the treatment of the HIV disease or
      any associated conditions. Weight will be measured and expressed as a percentage of ideal
      body weight (IBW) and body mass index. Blood will be sampled to determine hormonal function
      (testosterone, free testosterone, SHBG, estradiol, LH, and FSH), nutritional status (albumin,
      prealbumin), lipid parameters (HDL, LDL, cholesterol, triglycerides), immune function (CD4,
      viral load, CBC), and thrombolytic markers (t-PA, PAI-1). An HIV test will be performed at
      the baseline visit only, in order to document patient status. Glucose homeostasis will be
      measured with the use of fasting glucose and insulin levels and an oral glucose tolerance
      test (OGTT). Heart rate will be monitored to test cardiovascular function. A spot urine will
      be collected for bone markers and beta-human chorionic gonadotropin (bHCG). Lean body mass
      and fat mass will be determined by a dual energy x-ray absorptiometry [DEXA] (to be performed
      at the MIT CRC); total body water will be determined by bioimpedance analysis; muscle
      cross-sectional area will be determined by anthropometric measurements. A quantitative
      computed tomography (CT) scan of the thigh and abdomen will be done to measure visceral and
      subcutaneous fat. A Magnetic Resonance Spectroscopy of calf muscles for determination of
      lipid concentrations in skeletal muscle will be done. (Subjects with contraindications to
      magnetic resonance imaging [MRI] will be able to remain in the protocol, but the
      MR-Spectroscopy will not be performed). A complete dietary assessment and resting energy
      expenditure will be performed. Quality of life will be assessed using the MOS HIV
      questionnaire and an activity questionnaire as well as the Karnofsky performance assessment.

      A submaximal exercise bicycle test will be done to assess aerobic capability, and a 6 minute
      walk test, sit to stand and get up and go tests will be done to assess overall functional
      status by the physical therapy (PT) department. Those who are not randomized to exercise at
      the baseline visit, will have one repetition maximum (1 RM) testing. The 1 RM is defined as
      the maximal amount of weight that can be lifted throughout full range of motion. The 1 RM
      will be tested by performing exercises including calf raises, arm curls, lateral raises, knee
      flexors, bench press and half squats. The 1 RM testing will be repeated on those who are not
      randomized to exercise at the 8 and 16 week visits.

      After the baseline investigation is over, subjects will be randomized into one of two groups
      (exercise or no exercise) for 16 weeks. Strength training will be performed using standard
      free weights under the supervision of a trained physical therapist or member of the study
      staff. Each session begins with a 5 minute warm-up and a standard flexibility routine. The
      strength training routine will follow and will focus on the following muscle groups: knee
      extensors and hip extensors, ankle plantar flexors, elbow flexors, pectoralis and shoulder
      abduction. The aerobic training program will follow the general guidelines established by the
      American College of Sports Medicine. Training will be performed using a standard stationery
      bicycle. Aerobic/endurance exercise will be performed with large muscle groups. The duration
      of the aerobic component of the training session will be 20 minutes during the first two
      weeks and 30 minutes thereafter. The intensity of the exercise will be 60% of maximal heart
      rate during the first two weeks and 75% thereafter. As the weeks progress, the repetitions
      and intensity of the exercise will be gradually increased. Subjects return to the GCRC at 8
      weeks for a medical history, a physical exam, weight, and pregnancy test. Subjects return
      again at 16 weeks for a visit identical to that at baseline.
    

Intervention name(s): Progressive resistance and aerobic training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment