Healing Hearts and Mending Minds in Older Adults Living With HIV

Emory University115 enrolled

Overview

The purpose of this study is to see if exercise is helpful for improving memory, concentration thinking abilities, physical function, and quality of life for adults aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The study will test two kinds of intervention exercises: one group will walk for exercise and the second group will stretch for exercise. Members of 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

115

Conditions

HIV

Interventions

Let's Move ProgramBEHAVIORAL

Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.

Let's Flex ProgramBEHAVIORAL

Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.

Group Motivational InterviewingBEHAVIORAL

Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Stroop Color and Word Test Score

The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words "red, blue, and green" printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word "red" is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100.