- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101060
Strength Training and Endurance Exercise for LIFE (STEEL)
Effect of Exercise Training on Inflammation and Function in HIV Infected Veterans
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
Virginia
-
Salem, Virginia, United States, 24153
- Salem VA Medical Center, Salem, VA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-infected veterans adult 50 years of age and older under medical care for HIV
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
16-week progressive aerobic and resistance exercise training
|
16-week progressive aerobic and resistance exercise training
|
No Intervention: control
usual care controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic Capacity
Time Frame: at baseline and at 16 weeks (before and after the intervention phase)
|
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. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline). |
at baseline and at 16 weeks (before and after the intervention phase)
|
Diastolic Function
Time Frame: at baseline and at 16 weeks (before and after the intervention phase)
|
Exercise stress two-dimensional transthoracic echocardiography with tissue Doppler imaging (stress-echo) will be used to collect data on diastolic function. Reporting on ejection fraction. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline). |
at baseline and at 16 weeks (before and after the intervention phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers of Systemic Inflammation
Time Frame: at baseline and at 16 weeks (before and after the intervention phase)
|
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. Presenting IL-18 values (log converted for analysis). In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline). |
at baseline and at 16 weeks (before and after the intervention phase)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kris Ann K Oursler, MD, Salem VA Medical Center, Salem, VA
Publications and helpful links
General Publications
- Briggs BC, Ryan AS, Sorkin JD, Oursler KK. Feasibility and effects of high-intensity interval training in older adults living with HIV. J Sports Sci. 2021 Feb;39(3):304-311. doi: 10.1080/02640414.2020.1818949. Epub 2020 Sep 23.
- Oursler KK, O'Boyle HM, Briggs BC, Sorkin JD, Jarmukli N, Katzel LI, Freiberg MS, Ryan AS. Association of Diastolic Dysfunction with Reduced Cardiorespiratory Fitness in Adults Living with HIV. AIDS Patient Care STDS. 2019 Dec;33(12):493-499. doi: 10.1089/apc.2019.0149.
- Oursler KK, Iranmanesh A, Jain C, Birkett KL, Briggs BC, Garner DC, Sorkin JD, Ryan AS. Short Communication: Low Muscle Mass Is Associated with Osteoporosis in Older Adults Living with HIV. AIDS Res Hum Retroviruses. 2020 Apr;36(4):300-302. doi: 10.1089/AID.2019.0207. Epub 2019 Dec 23.
- Ryan AS, Roy A, Oursler KK. Gait and Balance Biomechanics in Older Adults With and Without Human Immunodeficiency Virus. AIDS Res Hum Retroviruses. 2019 Nov/Dec;35(11-12):1089-1094. doi: 10.1089/AID.2019.0102.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- O0667-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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