HIVFitBrainNCT02711878
Healing Hearts and Mending Minds in Older Adults Living With HIV
A study testing Let's Move Program, Let's Flex Program and Group Motivational Interviewing in people with HIV and Cardiovascular Disease, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- HIV, Cardiovascular Disease, AIDS
- What is being tested?
- Let's Move Program, Let's Flex Program and Group Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Ponce De Leon Center
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
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.
Read the 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 (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.
- Conditions
- HIV, Cardiovascular Disease, AIDS
- Being tested
- Let's Move Program, Let's Flex Program, Group Motivational Interviewing
- Medical subject headings
- Cardiovascular Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Move ProgramBehavioural
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 ProgramBehavioural
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 InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Let's Move Program | Experimental | 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. Receives: Behavioral: Let's Move Program; Behavioral: Group Motivational Interviewing |
| Let's Flex Program | Active comparator | 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. Receives: Behavioral: Let's Flex Program; Behavioral: Group Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Trail Making Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Letter Fluency Assessed by Change in FAS Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Category Fluency Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Hopkins Verbal Learning Test (HVLT) - Revised Score
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).
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Brief Visual Memory Test - Revised (BVMT-R) Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Grooved Pegboard Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Finger Tapping Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Coding Test Score
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).
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Digit Span Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Symbol Span Test Score
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.
Measured: Baseline, 3 months, 6 months and 12 months Post Intervention
Instrumental Activities of Daily Living (IADL) Test Score
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.
Measured: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
NIH Toolbox
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
Measured: Baseline, Post Intervention (Up to 58 weeks)
Secondary outcomes (5)
Soluble Cluster of Differentiation 14 (sCD14) Level
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.
Measured: Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)
Interleukin 6 (IL-6) Level
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.
Measured: Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)
Tumor Necrosis Factor Alpha (TNF-alpha) Level
TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha.
Measured: Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)
Brain-derived Neurotrophic Factor (BDNF) Level
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).
Measured: Baseline, Post Intervention (Up to 58 weeks)
Flow-Mediated Dilatation (FMD)
Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation.
Measured: Baseline, T2 (28-30 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startSep 2016
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Drenna Waldrop-Valverde, Emory University
- Investigators
- Drenna Waldrop-Valverde, PhD, Principal investigator, Emory UniversityRebecca Gary, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711878
- Sponsor's protocol ID
- IRB00080302
- Other IDs
- 1R01NR014973-01
- Acronym
- FitBrain
- Status last verified
- Jun 2023
- First submitted
- 14 Mar 2016
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Hearts and Mending Minds in Older Adults Living With HIV
- ClinicalTrials.gov ID
- NCT02711878
- Acronym / sponsor ID
- FitBrain / IRB00080302
- Conditions
- HIV, Cardiovascular Disease, AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2016
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Posted 1 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Let's Move Program | Experimental | Behavioral: Let's Move Program, Behavioral: Group Motivational InterviewingParticipants 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. |
| Let's Flex Program | Active comparator | Behavioral: Let's Flex Program, Behavioral: Group Motivational InterviewingParticipants 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. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Move ProgramParticipants 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. | Behavioural | Let's Move Program |
| Let's Flex ProgramParticipants 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. | Behavioural | Let's Flex Program |
| Group Motivational InterviewingParticipants 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. | Behavioural | Let's Flex Program, Let's Move Program |
Primary outcome
Stroop Color and Word Test Score
Time frame: Baseline, 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.
Trail Making Test Score
Time frame: Baseline, 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.
Letter Fluency Assessed by Change in FAS Test Score
Time frame: Baseline, 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.
Category Fluency Test Score
Time frame: Baseline, 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.
Hopkins Verbal Learning Test (HVLT) - Revised Score
Time frame: Baseline, 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).
Brief Visual Memory Test - Revised (BVMT-R) Score
Time frame: Baseline, 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.
Grooved Pegboard Test Score
Time frame: Baseline, 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.
Finger Tapping Test Score
Time frame: Baseline, 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.
Coding Test Score
Time frame: Baseline, 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).
Digit Span Test Score
Time frame: Baseline, 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.
Symbol Span Test Score
Time frame: Baseline, 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.
Instrumental Activities of Daily Living (IADL) Test Score
Time frame: Baseline, 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.
NIH Toolbox
Time frame: Baseline, 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
5 secondary outcomes
Soluble Cluster of Differentiation 14 (sCD14) Level
Time frame: Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)
Interleukin 6 (IL-6) Level
Time frame: Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)
Tumor Necrosis Factor Alpha (TNF-alpha) Level
Time frame: Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)
Brain-derived Neurotrophic Factor (BDNF) Level
Time frame: Baseline, Post Intervention (Up to 58 weeks)
Flow-Mediated Dilatation (FMD)
Time frame: Baseline, T2 (28-30 weeks post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drenna Waldrop-Valverde, PhD principal investigator
Emory University
Rebecca Gary, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Move Program, Let's Flex Program and Group Motivational Interviewing in people with HIV and Cardiovascular Disease, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop Color and Word Test Score (time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.