Healing Hearts and Mending Minds in Older Persons Living With HIV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Emory University
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to see if walking is effective for improving memory, concentration thinking abilities, physical function and quality of life of adults 50 years of age and older living with HIV.
Detailed Description
By 2015 more than half of persons living with HIV (PLWH) in the U.S. will be older than 50 years of age. Two factors contribute to the "graying" of the HIV epidemic. The overwhelming success of antiretroviral therapy (ART) has improved life expectancy and dramatically changed the trajectory of HIV; it is now a complex chronic condition, often associated with multiple comorbidities such as cardiovascular disease (CVD) and cognitive impairment (CI). Second, increasing numbers of middle-aged and older adults are becoming infected with HIV. Clinicians, patients, and society are currently ill-prepared to deal with the biomedical complexities and unique medical and psychosocial challenges associated with the growing aging HIV population. Aerobic exercise or exercise that speeds up the heart rate lowers CVD risk, and is known to improve physical and mental function with aging, but few well designed studies have reported use of aerobic exercise interventions in PLWH, and no studies have reported whether exercise improves cognitive function in this high risk for CI population. Regular aerobic exercise performed 5 times per week for 150 minutes has also been shown to improve aspects of cognitive function in community-dwelling older adults. Only one exercise study however, has examined the effect of exercise on cognition in PLWH and was limited by a self-reported, unreliable indicator of cognitive status; no studies have reported whether exercise improves cognition in this population using objective assessments, or examined the potential mechanisms involved. The home-based, 5 day per week moderate intensity walking intervention, the 'Let's Move Program,' has been tested and is effective for lowering CVD risk older caregivers and adults with advanced CVD. The proposed pre-post test pilot study will examine the feasibility of implementing the Lets Move Program among 40 PLWH over 6-months. Participants enrolled in the study will be ≥ 50 years of age, sedentary, have 2 CVD risk factors such as high blood pressure and obesity and demonstrate mild to moderate CI using standardized tests. Motivational Interviewing (MI) will be used to promote exercise confidence and optimize adherence to the intervention.
Investigators
Rebecca Gary
Associate Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •men and women aged 50 and over with 2 CVD risk factors (i.e., obesity, hypertension, hyperlipidemia) who are diagnosed with HIV/AIDS and willing to participate
- •English speaking
- •live independently and within a 30 mile radius of Atlanta
- •not involved in any structured exercise program or exercising 3 or more times per week for a minimum of 30 minutes
- •not involved in any weight loss program
- •not hospitalized within the last 60-days
- •clinically stable (absence of viral load and no active opportunistic infection), on ART 6 months before enrollment and a screening MOCA score ≤ 24 indicating mild cognitive impairment
Exclusion Criteria
- •non sedentary (defined as engaging in \> 30 minutes of moderately strenuous exercise 3 times or more a week)
- •medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, or a history of angina with activity
- •ischemic changes or inappropriate BP changes on BL exercise (modified Balke) treadmill test
- •on corticosteroids, experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply)
- •presence of current opportunistic infection
- •any terminal illness
- •regular use of anti-inflammatory medications such as non-steroidal anti-inflammatory agents
- •women who are pregnant
- •severe learning disabilities, intellectual disabilities, psychotic disorders to minimize confounding effects on neurocognitive data
- •confounding neuro-medical conditions (e.g., active CNS opportunistic infections, seizure disorders, head injury with loss of consciousness greater than 30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae, and non-HIV-associated dementias)
Outcomes
Primary Outcomes
Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame: Baseline, 3 months, 6 months
SST is a commonly used test of response inhibition. This test consists of two parts. In the first part, the subject is introduced to the press pad, and told to press the left hand button when they see a left-pointing arrow or press the right hand button when they see a right-pointing arrow. There is one block of 16 trials for the subject to practice this. In the second part, the subject is told to continue pressing the buttons on the press pad when they see the arrows, as before, but, if they hear an auditory signal (a beep), they should withhold their response and not press the button.
Secondary Outcomes
- Memory function as measured by delayed matching to sample (DMS) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, 3 months, 6 months)
- Memory function as measured by visual recognition memory (VRM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, 3 months, 6 months)
- Information processing speed as measured by choice reaction time (CRT)(Baseline, 3 months, 6 months)
- Interleukin 6 (IL-6) Levels(Baseline, 3 months, 6 months)
- Soluble CD14 (sCD14) Levels(Baseline, 3 months, 6 months)
- D-Dimer Levels(Baseline, 3 months, 6 months)
- Brain-derived Neurotrophic Factor (BDNF) Levels(Baseline, 3 months, 6 months)
- Flow-Mediated Dilation(Baseline, 3 months, 6 months)
- Executive function as measured by spatial working memory (SWM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, 3 months, 6 months)
- Executive function as measured by attention switching task (AST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, 3 months, 6 months)
- V02 max(Baseline, 3 months, 6 months)
- Beck Depression Inventory-II (BDI-II)(Baseline, 3 months, 6 months)
- Health-related Quality of Life (HRQoL)(Baseline, 3 months, 6 months)
- Exercise Adherence (number of exercise sessions recorded/number of sessions prescribed) × 100)(Baseline, 3 months, 6 months)
- Steps (measure of walking by a FitBit device)(Baseline, 3 months, 6 months)
- Step Calendar (document participants will be asked to record)(Baseline, 3 months, 6 months)
- Borg Rate of Perceived Exertion (RPE) Scale(Baseline, 3 months, 6 months)
- Target heart range (THR)(Baseline, 3 months, 6 months)
- Exercise Self Efficacy scale(Baseline, 3 months, 6 months)
- Outcome Expectations for Exercise Scale (OEE)(Baseline, 3 months, 6 months)