HIV
Conditions
Keywords
exercise, aging, aerobic capacity, cardiac function, inflammation
Brief summary
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.
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 40 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).
Interventions
OTHERexercise
16-week progressive aerobic and resistance exercise training
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic Capacity | 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). |
| Diastolic Function | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of Systemic Inflammation | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKris Ann K Oursler, MD
Salem VA Medical Center, Salem, VA
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise 16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training | 17 |
| Control usual care controls | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Control | Total | Exercise |
|---|---|---|---|
| Age, Continuous | 61.17 years STANDARD_DEVIATION 7.4 | 61.1 years STANDARD_DEVIATION 6.6 | 61.03 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 23 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 14 Participants | 30 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 1 / 17 | 2 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Aerobic Capacity
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).
Time frame: at baseline and at 16 weeks (before and after the intervention phase)
Population: We have incomplete data on completers in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Aerobic Capacity | 0.15 Liters/minute | Standard Error 0.04 |
| Control | Aerobic Capacity | 0.02 Liters/minute | Standard Error 0.07 |
Primary
Diastolic Function
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).
Time frame: at baseline and at 16 weeks (before and after the intervention phase)
Population: We have incomplete data on completers in these groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Diastolic Function | 1.8 percentage | Standard Error 1.9 |
| Control | Diastolic Function | 0.5 percentage | Standard Error 2.7 |
Secondary
Biomarkers of Systemic Inflammation
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).
Time frame: at baseline and at 16 weeks (before and after the intervention phase)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Biomarkers of Systemic Inflammation | -0.04 pg/mL | Standard Error 0.02 |
| Control | Biomarkers of Systemic Inflammation | -0.03 pg/mL | Standard Error 0.02 |