Strength Training and Endurance Exercise for LIFE (STEEL)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02101060
First received: March 18, 2014
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

Research is needed to determine safe and effective exercise rehabilitation programs to prevent and improve physical disability in older adults living with HIV. This problem is of great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50 years of age (64%). The combined effect of aging and inflammation increase the risk for physical disability in older HIV-infected veterans. This translational exercise training trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and resistance training to attenuate the functional declines of aging with HIV by reducing the deleterious consequences of chronic inflammation. Findings will guide future rehabilitation research on cardiac remodeling and inflammation of skeletal muscle. The proposed research will advance the goal to develop effective rehabilitation strategies that improve the health of older HIV-infected veterans.


Condition Intervention
HIV
Other: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of Exercise Training on Inflammation and Function in HIV Infected Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • aerobic capacity [ Time Frame: at baseline and at 16weeks (before and after the intervention phase) ] [ Designated as safety issue: No ]
    VO2 peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol.

  • diastolic function [ Time Frame: at baseline and at 16weeks (before and after the intervention phase) ] [ Designated as safety issue: No ]
    Exercise stress two-dimensional transthoracic echocardiography with tissue Doppler imaging (stress-echo) will be used to collect data on diastolic function.


Secondary Outcome Measures:
  • biomarkers of systemic inflammation [ Time Frame: at baseline and at 16weeks (before and after the intervention phase) ] [ Designated as safety issue: No ]
    Changes in plasma levels of biomarkers of chronic inflammation will be calculated pre/post intervention, and will be tested for association with changes in primary outcomes as well as between group differences.


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
16-week progressive aerobic and resistance exercise training
Other: exercise
16-week progressive aerobic and resistance exercise training
No Intervention: control
usual care controls

Detailed Description:

The objective of this study is to determine the effect of exercise training on the central (cardiovascular) and peripheral (muscular) impairments underlying poor physical function by comparing older HIV-infected veterans randomized to combine aerobic and resistance exercise training versus usual care. The study hypothesis is that a progressive aerobic and resistance rehabilitation program will increase aerobic capacity and muscle strength, which will be mediated by improved diastolic function, increased muscle mass, and decreased systemic inflammation. To test this hypothesis, investigators will conduct a randomized 16-week trial of progressive aerobic and resistance training versus usual care control in 60 sedentary older (50+ years) HIV-infected veterans. The study will determine the effects of exercise training on aerobic capacity and diastolic function, and their relationship to changes in biomarkers of systemic inflammation and cardiac fibrosis (AIM 1). The study will also determine the effect of exercise training on strength and muscle mass, and their relationship to changes in biomarkers of systemic inflammation (AIM 2).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected veterans adult 50 years of age and older receiving care at the Salem VA Medical Center
  • Antiretroviral Therapy

Exclusion Criteria:

  • Patients with comorbid conditions that could have a potential impact on their ability to perform exercise testing and training will be excluded according to the American College of Sports Medicine
  • Only sedentary adults will be eligible. Individuals that participate in regular structured aerobic exercise or resistance training in the prior 6-months will be excluded
  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: NCT02101060

Contacts
Contact: Kris Ann Oursler, MD KrisAnn.Oursler@va.gov
Contact: Ali Iranmanesh, MD (540) 982-2463 Ali.Iranmanesh@va.gov

Locations
United States, Virginia
Salem VA Medical Center, Salem, VA Not yet recruiting
Salem, Virginia, United States, 24153
Contact: Jeanne Whitbeck    540-983-1015    jeanne.whitbeck@va.gov   
Contact: Tracy Hicks    (540) 982-2463 ext 1568    Tracy.Hicks2@va.gov   
Principal Investigator: Kris Ann Oursler, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Kris Ann Oursler, MD Salem VA Medical Center, Salem, VA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02101060     History of Changes
Other Study ID Numbers: O0667-R
Study First Received: March 18, 2014
Last Updated: March 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
exercise
aging

ClinicalTrials.gov processed this record on July 28, 2014