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Healing Hearts and Mending Minds in Older Adults Living With HIV

NCT02711878, Not applicable, Completed, Emory University; results first posted 2022-07-01

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleHealing Hearts and Mending Minds in Older Adults Living With HIVClinicalTrials.gov
NCT numberNCT02711878ClinicalTrials.gov
StatusCompletedClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment115 participants, actualClinicalTrials.gov
Lead sponsorEmory UniversityClinicalTrials.gov
ConditionsHIV, Cardiovascular Disease, AIDSClinicalTrials.gov
InterventionsLet's Move Program, Let's Flex Program, Group Motivational InterviewingClinicalTrials.gov
First posted2016-03-17ClinicalTrials.gov
Last updated2023-07-06ClinicalTrials.gov
Results first posted2022-07-01ClinicalTrials.gov

Registered outcomes 23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryStroop Color and Word Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
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.
ClinicalTrials.gov
PrimaryTrail Making Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
ClinicalTrials.gov
PrimaryLetter Fluency Assessed by Change in FAS Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A \& S combined.
ClinicalTrials.gov
PrimaryCategory Fluency Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named.ClinicalTrials.gov
PrimaryHopkins Verbal Learning Test (HVLT) - Revised ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay).
ClinicalTrials.gov
PrimaryBrief Visual Memory Test - Revised (BVMT-R) ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome.
ClinicalTrials.gov
PrimaryGrooved Pegboard Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand.ClinicalTrials.gov
PrimaryFinger Tapping Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed.ClinicalTrials.gov
PrimaryCoding Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135).
ClinicalTrials.gov
PrimaryDigit Span Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome.
ClinicalTrials.gov
PrimarySymbol Span Test ScoreBaseline, 3 months, 6 months and 12 months Post Intervention
The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome.
ClinicalTrials.gov
PrimaryInstrumental Activities of Daily Living (IADL) Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living.
ClinicalTrials.gov
PrimaryNIH ToolboxBaseline, Post Intervention (Up to 58 weeks)
Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test
ClinicalTrials.gov
SecondarySoluble Cluster of Differentiation 14 (sCD14) LevelBaseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)
Soluble Cluster of Differentiation 14 (sCD14) is a marker of monocyte activation, is associated with neurocognitive impairment and HIV-associated neurocognitive disorders (HANDs) and higher mortality in persons living with HIV.
ClinicalTrials.gov
SecondaryInterleukin 6 (IL-6) LevelBaseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)
IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of cardiovascular disease (CVD) and cognitive impairment (CI) through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise congenital heart defect risk.
ClinicalTrials.gov
SecondaryTumor Necrosis Factor Alpha (TNF-alpha) LevelBaseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha.ClinicalTrials.gov
SecondaryBrain-derived Neurotrophic Factor (BDNF) LevelBaseline, Post Intervention (Up to 58 weeks)
BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in picogram per milliliter (pg/mL).
ClinicalTrials.gov
SecondaryFlow-Mediated Dilatation (FMD)Baseline, T2 (28-30 weeks post baseline)Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation.ClinicalTrials.gov
OtherPittsburgh Sleep Quality Index (PSQI) ScoreBaseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item measure of the quality and patterns of sleep among adults. Scoring is based on a 0 to 3 Likert scale. The global score is 21; total possible score ranges from 0 to 21. The higher the score the worse the sleep quality.
ClinicalTrials.gov
OtherBeck Depression Inventory-II (BDI-II) ScoreBaseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Scores range from 0-63. Interpretation: 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.
ClinicalTrials.gov

Outcomes 23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource
PRIMARYStroop Color and Word Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.number of correct responsesMEANClinicalTrials.gov
PRIMARYTrail Making Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.secondsMEANClinicalTrials.gov
PRIMARYLetter Fluency Assessed by Change in FAS Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.number of correct wordsMEANClinicalTrials.gov
PRIMARYCategory Fluency Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.Number of correct animals namedMEANClinicalTrials.gov
PRIMARYHopkins Verbal Learning Test (HVLT) - Revised ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.Number of correct words recalledMEANClinicalTrials.gov
PRIMARYBrief Visual Memory Test - Revised (BVMT-R) ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.number of correct figures recalledMEANClinicalTrials.gov
PRIMARYGrooved Pegboard Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.SecondsMEANClinicalTrials.gov
PRIMARYFinger Tapping Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.SecondsMEANClinicalTrials.gov
PRIMARYCoding Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.number of correct responsesMEANClinicalTrials.gov
PRIMARYDigit Span Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.number of correct digitsMEANClinicalTrials.gov
PRIMARYSymbol Span Test ScoreBaseline, 3 months, 6 months and 12 months Post InterventionThe number analyzed includes participants who were able to complete each study visit.score on a scaleMEANClinicalTrials.gov
PRIMARYInstrumental Activities of Daily Living (IADL) Test ScoreBaseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.Score on a scaleMEANClinicalTrials.gov
PRIMARYNIH ToolboxBaseline, Post Intervention (Up to 58 weeks)In order to reduce participant burden, the NIH toolbox neurocognitive tests were not administered because was redundant with the outcomes measured by the other cognitive tests.ClinicalTrials.gov
SECONDARYSoluble Cluster of Differentiation 14 (sCD14) LevelBaseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.pg/mlMEANClinicalTrials.gov
SECONDARYInterleukin 6 (IL-6) LevelBaseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.pg/mlMEANClinicalTrials.gov
SECONDARYTumor Necrosis Factor Alpha (TNF-alpha) LevelBaseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.pg/mlMEANClinicalTrials.gov
SECONDARYBrain-derived Neurotrophic Factor (BDNF) LevelBaseline, Post Intervention (Up to 58 weeks)pg/mLMEANClinicalTrials.gov
SECONDARYFlow-Mediated Dilatation (FMD)Baseline, T2 (28-30 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.percent dilationMEANClinicalTrials.gov
OTHER_PRE_SPECIFIEDPittsburgh Sleep Quality Index (PSQI) ScoreBaseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.score on a scaleMEANClinicalTrials.gov
OTHER_PRE_SPECIFIEDBeck Depression Inventory-II (BDI-II) ScoreBaseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)The number analyzed includes participants who were able to complete each study visit.score on a scaleMEANClinicalTrials.gov

Results by group 194

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource
Stroop Color and Word Test ScoreLet's Move ProgramBaseline31.17Standard Deviation 8.13number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Flex ProgramBaseline28.89Standard Deviation 7.59number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Move ProgramT1 (13-15 weeks post baseline)32.87Standard Deviation 8.85number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Flex ProgramT1 (13-15 weeks post baseline)30.69Standard Deviation 6.64number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Move ProgramT2 (28-30 weeks post baseline)33.09Standard Deviation 8.72number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Flex ProgramT2 (28-30 weeks post baseline)30.39Standard Deviation 9.5number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Move ProgramT3 ( 56-58 weeks post baseline)33.44Standard Deviation 8.74number of correct responsesClinicalTrials.gov
Stroop Color and Word Test ScoreLet's Flex ProgramT3 ( 56-58 weeks post baseline)31.77Standard Deviation 7.83number of correct responsesClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart A - Baseline35.84Standard Deviation 14.11secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart A - Baseline37.74Standard Deviation 20.08secondsClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart A -T1 (13-15 weeks post baseline)33.62Standard Deviation 12.39secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart A -T1 (13-15 weeks post baseline)35.58Standard Deviation 16.51secondsClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart A - T2 (28-30 weeks post baseline)34.73Standard Deviation 17.54secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart A - T2 (28-30 weeks post baseline)39.03Standard Deviation 15.62secondsClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart A - T3 ( 56-58 weeks post baseline)33.29Standard Deviation 12.49secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart A - T3 ( 56-58 weeks post baseline)36.23Standard Deviation 12.92secondsClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart B - Baseline113.7Standard Deviation 62.29secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart B - Baseline137.95Standard Deviation 86.58secondsClinicalTrials.gov
Trail Making Test ScoreLet's Move ProgramPart B -T1 (13-15 weeks post baseline)109.51Standard Deviation 58.68secondsClinicalTrials.gov
Trail Making Test ScoreLet's Flex ProgramPart B -T1 (13-15 weeks post baseline)142.26Standard Deviation 93.74secondsClinicalTrials.gov

Participant flow 12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource
Overall StudySTARTEDLet's Move Program76ClinicalTrials.gov
Overall StudySTARTEDLet's Flex Program39ClinicalTrials.gov
Overall StudyCompleted Visit T1 (13-15 Weeks Post Baseline)Let's Move Program69ClinicalTrials.gov
Overall StudyCompleted Visit T1 (13-15 Weeks Post Baseline)Let's Flex Program33ClinicalTrials.gov
Overall StudyCompleted Visit T2 (28-30 Weeks Post Baseline)Let's Move Program68ClinicalTrials.gov
Overall StudyCompleted Visit T2 (28-30 Weeks Post Baseline)Let's Flex Program33ClinicalTrials.gov
Overall StudyCompleted Visit T3 (56-58 Weeks Post Baseline)Let's Move Program72ClinicalTrials.gov
Overall StudyCompleted Visit T3 (56-58 Weeks Post Baseline)Let's Flex Program31ClinicalTrials.gov
Overall StudyCOMPLETEDLet's Move Program68ClinicalTrials.gov
Overall StudyCOMPLETEDLet's Flex Program33ClinicalTrials.gov
Overall StudyNOT COMPLETEDLet's Move Program8ClinicalTrials.gov
Overall StudyNOT COMPLETEDLet's Flex Program6ClinicalTrials.gov

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 6

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource
Total, all-cause mortalityLet's Move Program076ClinicalTrials.gov
Total, all-cause mortalityLet's Flex Program039ClinicalTrials.gov
Total, other adverse eventsLet's Move Program076ClinicalTrials.gov
Total, other adverse eventsLet's Flex Program039ClinicalTrials.gov
Total, serious adverse eventsLet's Move Program076ClinicalTrials.gov
Total, serious adverse eventsLet's Flex Program039ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource
R01NR014973Healing Hearts, Mending Minds in Older Persons with HIVWALDROP, DRENNA; GARY, REBECCA AEMORY UNIVERSITYNATIONAL INSTITUTE OF NURSING RESEARCH2015 to 2018NIH RePORTER

Trial comparisons 2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Let's Move Program vs Let's Flex Program: deaths from any causeTrial comparisons
Let's Move Program vs Let's Flex Program: serious adverse eventsTrial comparisons

Tests 15

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Category FluencyPrimary outcomeConductCognition
Digit Span TestPrimary outcomeConductCognition
Dimensional Change Card SortPrimary outcomeConductCognition
Finger Tapping TaskPrimary outcomeConductCognition
Pattern and Letter ComparisonPrimary outcomeConductCognition
Picture Order Memory TestPrimary outcomeConductCognition
Size Order Memory TestPrimary outcomeConductCognition
Stroop Color-Word TestPrimary outcomeConductCognition
Symbol CodingPrimary outcomeConductCognition
Task Switching TestPrimary outcomeConductCognition
Trail Making Test APrimary outcomeConductCognition
Trail Making Test BPrimary outcomeConductCognition
Verbal FluencyPrimary outcomeConductCognition
Verbal LearningPrimary outcomeConductCognition
Vocabulary TestPrimary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)