Status:
COMPLETED
Healing Hearts and Mending Minds in Older Adults Living With HIV
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
HIV
Cardiovascular Disease
Eligibility:
All Genders
40-89 years
Phase:
NA
Brief Summary
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...
Detailed 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 (stretc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT02711878
Start Date
September 1 2016
End Date
December 20 2019
Last Update
July 6 2023
Active Locations (3)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Ponce De Leon Center
Atlanta, Georgia, United States, 30308
3
Emory University Hospital
Atlanta, Georgia, United States, 30322