Healing Hearts and Mending Minds in Older Adults Living With HIV

This is a two arm, randomized controlled trial to test the longitudinal effects of the Let's
Move Program (walking for exercise) compared to effects of the attention control Let's Flex
Program (stretching for exercise) in participants aged 50 to 89 years living with HIV and who
have two or more cardiovascular disease risk factors. Participants in both interventions will
be asked to participate in one-on-one interviews/assessments, measures of physical
functioning, and some sessions with others who are also enrolled in the study. Participants
will participate in an in home exercise program for twelve weeks in which the study team will
help identify maximum duration and intensity followed by a maintenance period for weeks
13-58.

Inclusion Criteria:

- HIV diagnosis

- English speaking

- Live independently within a 30-45 mile radius of Atlanta, Georgia

- 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 and on antiretroviral therapy (ART) 6 months before enrollment

- If taking statins, stable on medication for 3 months

- Score 3 or less on the verbal memory subtest of the Montreal Cognitive Assessment
(MoCA)

- Less than 0.5 standard deviations (SD) below mean on the Oral Trail Making Test B

- Able to provide informed consent and pass a consent post-test

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, lower extremity
amputations, joint replacement(s), balance disorders, dizziness, dyspnea on exertion
(DOE) with moderate exertion, difficulty walking one block, recent falls, obvious
injury to lower extremity, uncontrolled hypertension or diabetes, renal failure,
blindness, or a history of angina with activity)

- Ischemic changes or inappropriate BP changes on baseline exercise (modified Balke or
Bruce) treadmill test

- On oral corticosteroids (nasal, optical and inhaler corticosteroids allowed without
restriction) , experiencing acute inflammation at time of baseline or follow-up
testing (this will result in rescheduling of testing if no other exclusion criteria
apply after 2 weeks)

- Presence of current opportunistic infection

- Any terminal illness

- Regular use of anti-inflammatory medications such as non-steroidal anti-inflammatory
agents excluding low dose aspirin

- On anti-psychotics

- On tricyclic antidepressants

- On anti-depressants equal to the equivalent of more than 1 mg of Clonazepam

- On Lithium

- Women who are pregnant

- Severe learning disabilities, intellectual disabilities, schizophrenia, bipolar,
psychotic disorders to minimize confounding effects on neurocognitive data

- Confounding neuro-medical conditions (e.g., active central nervous system (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)

- Meet criteria for any Substance Use Disorder or Major Depression within 6 months of
evaluation

- Creatinine > 2.5 within the past 6 months

- Patient Health Questionnaire-2 (PHQ-2) score > 4

- Completed 8 years or less of school

- Failed to pass post-consent test after three attempts

- Two or more positive drug screen tests

- Alcohol breathalyzer test result > 0.03