Healing Hearts and Mending Minds in Older Adults Living With HIV (FitBrain)

Emory University

Status: Completed

Conditions: AIDS; HIV; Cardiovascular Disease

Treatments: Behavioral: Let's Flex Program; Behavioral: Let's Move Program; Behavioral: Group Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02711878

IRB00080302

1R01NR014973-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 115 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Let's Move Program

Experimental group

Description:

Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks.

Treatment:

Behavioral: Group Motivational Interviewing

Behavioral: Let's Move Program

Let's Flex Program

Active Comparator group

Description:

Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks.

Treatment:

Behavioral: Group Motivational Interviewing

Behavioral: Let's Flex Program