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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR014973-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Let's Move Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score | 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. | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drenna Waldrop-Valverde, PhD | Emory University | Principal Investigator |
| Rebecca Gary, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Ponce De Leon Center |
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Participants were enrolled between September 2016 and December 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Let's Move Program | 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. Let's Move Program: 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. Group Motivational Interviewing: 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. |
| FG001 | Let's Flex Program | 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. Let's Flex Program: 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 Interviewing: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Let's Move Program | 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. Let's Move Program: 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. Group Motivational Interviewing: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | number of correct responses | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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Patients were followed for the duration of the study (up to 58 weeks post intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Let's Move Program | 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. Let's Move Program: 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. Group Motivational Interviewing: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eun Ok IM | Emory university | 404-712-9805 | eun.ok.im@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2018 | Apr 13, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2018 | Jan 29, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Let's Flex Program | Behavioral | 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 Interviewing | Behavioral | 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. |
|
| 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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 | Baseline, Post Intervention (Up to 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. | 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. | 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). | 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. | Baseline, T2 (28-30 weeks post baseline) |
| Beck Depression Inventory-II (BDI-II) Score | 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. | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
| Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise. | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
| V02 Max Rate | V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome. | Baseline |
| Six-minute Walk Test | Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome. | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| BG001 | Let's Flex Program | 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. Let's Flex Program: 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 Interviewing: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Data was collected at the School of Nursing and at the Clinical Translational Science Institute of Atlanta at each measurement point. | Count of Participants | Participants |
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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.
Let's Move Program: 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.
Group Motivational Interviewing: 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.
| OG001 | Let's Flex Program | 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. Let's Flex Program: 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 Interviewing: 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. |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | seconds | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | number of correct words | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis. | Posted | Mean | Standard Deviation | Number of correct animals named | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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). | Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis. | Posted | Mean | Standard Deviation | Number of correct words recalled | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis. | Posted | Mean | Standard Deviation | number of correct figures recalled | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | Seconds | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | Seconds | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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). | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | number of correct responses | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | number of correct digits | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months and 12 months Post Intervention |
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| Primary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
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| Primary | 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 | 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. | Posted | Baseline, Post Intervention (Up to 58 weeks) |
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| Secondary | 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. | Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing. | Posted | Mean | Standard Deviation | pg/ml | Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks) |
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| Secondary | 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. | Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing. | Posted | Mean | Standard Deviation | pg/ml | Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks) |
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| Secondary | 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. | Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing. | Posted | Mean | Standard Deviation | pg/ml | Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks) |
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| Secondary | 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). | Posted | Mean | Standard Deviation | pg/mL | Baseline, Post Intervention (Up to 58 weeks) |
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| Secondary | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | percent dilation | Baseline, T2 (28-30 weeks post baseline) |
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| Other Pre-specified | Pittsburgh Sleep Quality Index (PSQI) Score | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
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| Other Pre-specified | Beck Depression Inventory-II (BDI-II) Score | 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. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
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| Other Pre-specified | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | hours per week | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
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| Other Pre-specified | V02 Max Rate | V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome. | Number analyzed includes participants that completed the baseline visit. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline |
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| Other Pre-specified | Six-minute Walk Test | Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome. | The number analyzed includes participants who were able to complete each study visit. | Posted | Mean | Standard Deviation | distance walked in feet | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) |
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| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Let's Flex Program | 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. Let's Flex Program: 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 Interviewing: 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. | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Part A -T1 (13-15 weeks post baseline) |
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| Part A - T2 (28-30 weeks post baseline) |
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| Part A - T3 ( 56-58 weeks post baseline) |
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| Part B - Baseline |
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| Part B -T1 (13-15 weeks post baseline) |
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| Part B - T2 (28-30 weeks post baseline) |
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| Part B - T3 ( 56-58 weeks post baseline) |
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| T1 ( 13-15 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 ( 56-58 weeks post baseline) |
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| T1 (13-15 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| Total recall - T1 ( 13-15 weeks post baseline) |
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| Total recall - T2 (28-30 weeks post baseline) |
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| Total recall - T3 ( 56-58 weeks post baseline) |
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| Delayed recall - Baseline |
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| Delayed recall - T1 ( 13-15 weeks post baseline) |
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| Delayed recall - T2 (28-30 weeks post baseline) |
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| Delayed recall - T3 ( 56-58 weeks post baseline) |
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| Total recall - T1 ( 13-15 weeks post baseline) |
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| Total recall - T2 (28-30 weeks post baseline) |
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| Total recall - T3 ( 56-58 weeks post baseline) |
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| Delayed recall - Baseline |
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| Delayed recall - T1 ( 13-15 weeks post baseline) |
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| Delayed recall - T2 (28-30 weeks post baseline) |
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| Delayed recall - T3 ( 56-58 weeks post baseline) |
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| Dominant Hand - T1 ( 13-15 weeks post baseline) |
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| Dominant Hand -T2 (28-30 weeks post baseline) |
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| Dominant Hand -T3 (56-58 weeks post baseline) |
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| Nondominant Hand - Baseline |
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| Nondominant Hand - T1 ( 13-15 weeks post baseline) |
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| Nondominant Hand -T2 (28-30 weeks post baseline) |
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| Nondominant Hand -T3 (56-58 weeks post baseline) |
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| Dominant hand -T1 ( 13-15 weeks post baseline) |
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| Dominant hand -T2 ( 28-30 weeks post baseline) |
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| Dominant hand -T2 ( 56-58 weeks post baseline) |
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| Nondominant hand - Baseline |
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| Nondominant hand -T1 ( 13-15 weeks post baseline) |
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| Nondominant hand -T2 ( 28-30 weeks post baseline) |
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| Nondominant hand -T2 ( 56-58 weeks post baseline) |
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| T1 (13-15 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| T1 (13-15 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 ( 56-58 weeks post baseline) |
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| 3 months post-intervention |
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| 6 months post-intervention |
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| 12 months post-intervention |
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| T1 (13-15 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| T2 (28-30 wks) |
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| T3 (56-58 wks) |
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| T2 (28-30 wks) |
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| T3 (56-58 wks) |
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| T2 (28-30 weeks) |
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| T3 (56-58 weeks) |
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| T2 (28-30 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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| T2 (28-30 weeks post baseline) |
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| T3 (56-58 weeks post baseline) |
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