Clinical trial NCT02315742: Hearts and Minds in HIV
Official title: Healing Hearts and Mending Minds in Older Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)
* active substance abuse and major depression

Primary outcomes:
measure: Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Executive function as measured by spatial working memory (SWM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, 3 months, 6 months
measure: Executive function as measured by attention switching task (AST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, 3 months, 6 months
measure: Memory function as measured by delayed matching to sample (DMS) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, 3 months, 6 months
measure: Memory function as measured by visual recognition memory (VRM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline, 3 months, 6 months
measure: Information processing speed as measured by choice reaction time (CRT)
timeFrame: Baseline, 3 months, 6 months
measure: Interleukin 6 (IL-6) Levels
timeFrame: Baseline, 3 months, 6 months
measure: Soluble CD14 (sCD14) Levels
timeFrame: Baseline, 3 months, 6 months
measure: D-Dimer Levels
timeFrame: Baseline, 3 months, 6 months
measure: Brain-derived Neurotrophic Factor (BDNF) Levels
timeFrame: Baseline, 3 months, 6 months
measure: Flow-Mediated Dilation
timeFrame: Baseline, 3 months, 6 months
measure: V02 max
timeFrame: Baseline, 3 months, 6 months
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, 3 months, 6 months
measure: Health-related Quality of Life (HRQoL)
timeFrame: Baseline, 3 months, 6 months
measure: Exercise Adherence (number of exercise sessions recorded/number of sessions prescribed) × 100)
timeFrame: Baseline, 3 months, 6 months
measure: Steps (measure of walking by a FitBit device)
timeFrame: Baseline, 3 months, 6 months
measure: Step Calendar (document participants will be asked to record)
timeFrame: Baseline, 3 months, 6 months
measure: Borg Rate of Perceived Exertion (RPE) Scale
timeFrame: Baseline, 3 months, 6 months
measure: Target heart range (THR)
timeFrame: Baseline, 3 months, 6 months
measure: Exercise Self Efficacy scale
timeFrame: Baseline, 3 months, 6 months
measure: Outcome Expectations for Exercise Scale (OEE)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Ponce de Leon Center of the Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: AbsoluteCARE, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital Infectious Diseases Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Rebecca Gary, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: