Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Home-Based Resistance and Strength Training in HIV-Infected Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00111332
First received: May 19, 2005
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Progressive resistance and aerobic training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Effects in HIV-Infected Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • aerobic fitness

Secondary Outcome Measures:
  • strength
  • body composition
  • lipids
  • glucose
  • cardiovascular disease (CVD) risk markers

Estimated Enrollment: 40
Study Start Date: November 2002
Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111332

Locations
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00111332     History of Changes
Other Study ID Numbers: 49302-P2 (completed), R01DK049302
Study First Received: May 19, 2005
Last Updated: April 12, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014