N/A
N=115
Healing Hearts and Mending Minds in Older Adults Living With HIV
HIV · Cardiovascular Disease · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT02711878 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Stroop Color and Word Test Score — 31.17; 28.89; 32.87; 30.69 number of correct responses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Let's Move Program (Behavioral); Let's Flex Program (Behavioral); Group Motivational Interviewing (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroop Color and Word Test Score |
31.17; 28.89; 32.87; 30.69; 33.09; 30.39 | — |
| PRIMARY Trail Making Test Score |
35.84; 37.74; 33.62; 35.58; 34.73; 39.03 | — |
| PRIMARY Letter Fluency Assessed by Change in FAS Test Score |
35.91; 31.44; 38.51; 31.28; 37.26; 34.33 | — |
| PRIMARY Category Fluency Test Score |
19.97; 18.89; 19.87; 17.63; 20.24; 17.82 | — |
| PRIMARY Hopkins Verbal Learning Test (HVLT) - Revised Score |
6.65; 6.46; 6.87; 6.65; 6.56; 7 | — |
| PRIMARY Brief Visual Memory Test - Revised (BVMT-R) Score |
16.97; 15.97; 19.99; 17.16; 19.59; 18.18 | — |
| PRIMARY Grooved Pegboard Test Score |
100.26; 103.46; 91.49; 101.94; 90.81; 101.78 | — |
| PRIMARY Finger Tapping Test Score |
36.21; 32.83; 39.34; 33.9; 38.19; 34.31 | — |
| PRIMARY Coding Test Score |
46.07; 45.69; 45.31; 43.13; 47.89; 42.84 | — |
| PRIMARY Digit Span Test Score |
23.19; 21.67; 24.32; 22.41; 23.86; 21.76 | — |
| PRIMARY Symbol Span Test Score |
17.19; 15.33; 19.56; 16.78; 19.17; 17.18 | — |
| PRIMARY Instrumental Activities of Daily Living (IADL) Test Score |
7.95; 7.86; 7.96; 7.9; 7.83; 7.93 | — |
| PRIMARY NIH Toolbox |
— | — |
| SECONDARY Soluble Cluster of Differentiation 14 (sCD14) Level |
2306.0; 2373.1; 2315.5; 2342.6 | — |
| SECONDARY Interleukin 6 (IL-6) Level |
2.5; 5.4; 2.5; 5.1; 2.3; 4.7 | — |
| SECONDARY Tumor Necrosis Factor Alpha (TNF-alpha) Level |
1.6; 1.6; 1.7; 1.71; 1.6; 1.75 | — |
| SECONDARY Brain-derived Neurotrophic Factor (BDNF) Level |
2436.95; 2910.17; 3142.40; 2963.97; 3014.45; 2895.28 | — |
| SECONDARY Flow-Mediated Dilatation (FMD) |
4.62; 5.64; 4.31; 5.48 | — |
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 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02711878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.