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COVID-19 Risk
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| Name | Class |
|---|---|
| University of Missouri, St. Louis | OTHER |
| University of California, San Diego | OTHER |
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Management and treatment of older persons living with HIV (PLWH) (≥ 40 years old) is becoming increasingly more complex as a majority is greater than 40 years old. This proposal will conduct a prospective controlled intervention trial to assess the quantitative and qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a social-interaction stretching (SIS) program on brain health (neuropsychological performance testing and neuroimaging measurements) in older PLWH. These results could influence public health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate the development of effective EXS programs for older PLWH.
Management of older persons living with HIV (PLWH) (≥ 40 years old) is becoming increasingly more complex as a majority is greater than 40 years old. Attempts to improve the quality of life of older PLWH using adjunctive therapeutics to combination antiretroviral therapy (cART) have largely been unsuccessful.
While the impact of physical activity on brain health (assessed by neuropsychological performance and neuroimaging) has been well studied in older healthy HIV uninfected (HIV-) individuals and neurodegenerative conditions, few studies have concentrated on older PLWH. Both clinically and pathophysiologically, HIV associated neurocognitive disorders (HAND) differs from other neurodegenerative disorders seen with aging (e.g. Alzheimer's disease (AD). A positive association relationship between exercise and cognition has been observed in PLWH, but physical activity has been primarily examined using self-report questionnaires that are subjective and not quantitative. To date, no study has focused on the direct effects of exercise on neuropsychological performance or neuroimaging in PLWH.
The objective of this proposal is to conduct a prospective controlled intervention trial to determine if an increase in physical activity through a monitored aerobic and resistance exercise (EXS) program improves brain health in older PLWH. We will quantify physical function (physical activity using cardiorespiratory capacity and actigraphy) and brain function [neuropsychological performance testing and neuroimaging (cerebral blood flow (CBF) and brain volume)] in older physically inactive PLWH at baseline and 26 weeks after randomization to either an EXS or a social-interaction stretching (SIS) program. In addition, we will obtain stool samples, serum markers of neurogenesis, glucose regulation, and systemic inflammation.
A direct impact of these expected outcomes will be the adoption of a more physically active lifestyle by older PLWH and improved EXS guidelines and programs for older PLWH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise (EXS) | Experimental | All EXS sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion exercises. Participants will follow an individualized exercise training prescription based on baseline cardiovascular testing. Individual aerobic exercise intensity is based on % of maximum heart rate achieved during the baseline cardiorespiratory fitness test. The target exercise HR will start at 50% and progress to 85% HR reserve. During aerobic exercise, a battery-operated HR monitor will monitor HR. Exercise intensity & duration will be increased as the participant acclimates to the exercise prescription. Adaptation is determined when a given exercise intensity yields a lower HR than prior sessions conducted at the same intensity. |
|
| Social Interaction Stretching (SIS) | Active Comparator | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | The resistance exercise training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response, and when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group | This measure examines the global z-score which is an average of all the individual cognitive test z scores. We looked at changes in global Z-scores from baseline to follow-up (6 months). A Z-score of 0 represents the population mean. Z-scores are considered to be better when they are above the mean and represent a better outcome. | 6 months |
| Changes in Brain Structural/Functional Measures in Older PLWH | The Investigators will assess if an EXS program improves brain structure and function more than a SIS program in older sedentary PLWH. Changes in brain volumetrics (total cortex volume) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups. | 26 weeks |
| Change in Level of Daily Activity | Investigators will examine the amount of change in daily activity based on 7-day actigraphy at baseline and then again at follow-up (26 weeks later). Daily activity is measured using an actigraph that participants wear on their wrist and it measures the amount of time spent in sedentary, slightly active, moderately active, vigorously active or very vigorously active categories. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beau M Ances, MD,PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23860944 | Background | Spudich S. HIV and neurocognitive dysfunction. Curr HIV/AIDS Rep. 2013 Sep;10(3):235-43. doi: 10.1007/s11904-013-0171-y. | |
| 22675662 | Background | Spudich S, Gonzalez-Scarano F. HIV-1-related central nervous system disease: current issues in pathogenesis, diagnosis, and treatment. Cold Spring Harb Perspect Med. 2012 Jun;2(6):a007120. doi: 10.1101/cshperspect.a007120. |
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Data will be shared when the study has closed.
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Participants were recruited from local clinics as well as a participant registry. Recruitment started in July of 2015 and concluded in November of 2020. There was a pause in recruitment due to the COVID-19 Pandemic from March 2020 through August 2020, and then was terminated early due to a rise in cases in our area in November 2020. A total of 462 were initially screened for the study & 75 were initially enrolled in the study. Out of those 75, a total of 65 were randomized into the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise (EXS) | All EXS sessions will be held at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion exercises. Participants will follow an individualized exercise training prescription based on baseline cardiovascular testing. Individual aerobic exercise intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, a battery-operated HR monitor will monitor HR. Exercise intensity & duration will be increased as the participant acclimates to the exercise prescription. Adaptation is determined when a given exercise intensity yields a lower HR than prior sessions conducted at the same intensity. The resistance EXS training component will follow aerobic EXS & will consist of 4 upper & 3 lower body routines. A combination of guided-motion machines & free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response & when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks. |
| FG001 | Social Interaction Stretching (SIS) | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. Stretching and Social Interaction: Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise (EXS) | EXS sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Sessions will start with range of motion EXS. Participants will follow an individualized EXS training prescription based on baseline cardio testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, HR will be monitored by a battery-operated monitor. EXS intensity & duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity. Exercise: The resistance EXS training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines & free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, & when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group | This measure examines the global z-score which is an average of all the individual cognitive test z scores. We looked at changes in global Z-scores from baseline to follow-up (6 months). A Z-score of 0 represents the population mean. Z-scores are considered to be better when they are above the mean and represent a better outcome. | All participants who completed cognitive testing at baseline and 6 months. | Posted | Mean | Standard Deviation | z-score | 6 months |
|
Through study completion, an average of approximately 6 months per participant.
Adverse events were defined by the clinicaltrials.gov definitions.
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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 | Exercise (EXS) | All EXS sessions will be at a facility at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion EXS. Participants will follow an individualized EXS training prescription based on baseline cardiovascular testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic exercise, a battery-operated HR monitor will monitor HR. Exercise intensity & duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity. Exercise: The resistance EXS training component will follow aerobic EXS and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each EXS station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, and when the participant can comfortably lift the weight for 12 repetitions on any EXS, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each EXS over 26 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brittany Nelson, Senior Clinical Research Coordinator | Washington University in St. Louis | 314-747-8425 | bmnelson@wustl.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 | Apr 7, 2020 | Nov 2, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2020 | Oct 5, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Stretching and Social Interaction | Behavioral | Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. |
|
| 24156898 | Background | Clifford DB, Ances BM. HIV-associated neurocognitive disorder. Lancet Infect Dis. 2013 Nov;13(11):976-86. doi: 10.1016/S1473-3099(13)70269-X. |
| 16643776 | Background | Shah S, Mildvan D. HIV and aging. Curr Infect Dis Rep. 2006 May;8(3):241-7. doi: 10.1007/s11908-006-0065-x. |
| 16619159 | Background | Valcour V, Paul R. HIV infection and dementia in older adults. Clin Infect Dis. 2006 May 15;42(10):1449-54. doi: 10.1086/503565. Epub 2006 Apr 13. |
| 18677024 | Background | Hall HI, Song R, Rhodes P, Prejean J, An Q, Lee LM, Karon J, Brookmeyer R, Kaplan EH, McKenna MT, Janssen RS; HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008 Aug 6;300(5):520-9. doi: 10.1001/jama.300.5.520. |
| 24816714 | Background | Ortega M, Ances BM. Role of HIV in amyloid metabolism. J Neuroimmune Pharmacol. 2014 Sep;9(4):483-91. doi: 10.1007/s11481-014-9546-0. Epub 2014 May 10. |
| 19016329 | Background | Xu J, Ikezu T. The comorbidity of HIV-associated neurocognitive disorders and Alzheimer's disease: a foreseeable medical challenge in post-HAART era. J Neuroimmune Pharmacol. 2009 Jun;4(2):200-12. doi: 10.1007/s11481-008-9136-0. Epub 2008 Nov 19. |
| 25848401 | Background | Cohen RA, Seider TR, Navia B. HIV effects on age-associated neurocognitive dysfunction: premature cognitive aging or neurodegenerative disease? Alzheimers Res Ther. 2015 Apr 6;7(1):37. doi: 10.1186/s13195-015-0123-4. eCollection 2015. |
| 21719610 | Background | Desquilbet L, Jacobson LP, Fried LP, Phair JP, Jamieson BD, Holloway M, Margolick JB. A frailty-related phenotype before HAART initiation as an independent risk factor for AIDS or death after HAART among HIV-infected men. J Gerontol A Biol Sci Med Sci. 2011 Sep;66(9):1030-8. doi: 10.1093/gerona/glr097. Epub 2011 Jun 30. |
| 20425560 | Background | Justice AC. HIV and aging: time for a new paradigm. Curr HIV/AIDS Rep. 2010 May;7(2):69-76. doi: 10.1007/s11904-010-0041-9. |
| 19751364 | Background | Justice AC, McGinnis KA, Skanderson M, Chang CC, Gibert CL, Goetz MB, Rimland D, Rodriguez-Barradas MC, Oursler KK, Brown ST, Braithwaite RS, May M, Covinsky KE, Roberts MS, Fultz SL, Bryant KJ; VACS Project Team. Towards a combined prognostic index for survival in HIV infection: the role of 'non-HIV' biomarkers. HIV Med. 2010 Feb;11(2):143-51. doi: 10.1111/j.1468-1293.2009.00757.x. Epub 2009 Sep 14. |
| 19706308 | Background | Onen NF, Agbebi A, Shacham E, Stamm KE, Onen AR, Overton ET. Frailty among HIV-infected persons in an urban outpatient care setting. J Infect. 2009 Nov;59(5):346-52. doi: 10.1016/j.jinf.2009.08.008. Epub 2009 Aug 23. |
| 16107986 | Background | Casau NC. Perspective on HIV infection and aging: emerging research on the horizon. Clin Infect Dis. 2005 Sep 15;41(6):855-63. doi: 10.1086/432797. Epub 2005 Jul 28. |
| 25771249 | Background | Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12. |
| 20847403 | Background | Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79. doi: 10.3233/JAD-2010-100768. |
| 24662570 | Background | Damirchi A, Tehrani BS, Alamdari KA, Babaei P. Influence of aerobic training and detraining on serum BDNF, insulin resistance, and metabolic risk factors in middle-aged men diagnosed with metabolic syndrome. Clin J Sport Med. 2014 Nov;24(6):513-8. doi: 10.1097/JSM.0000000000000082. |
| 23737675 | Background | Balsamo S, Willardson JM, Frederico Sde S, Prestes J, Balsamo DC, Dahan da CN, Dos Santos-Neto L, Nobrega OT. Effectiveness of exercise on cognitive impairment and Alzheimer's disease. Int J Gen Med. 2013 May 24;6:387-91. doi: 10.2147/IJGM.S35315. Print 2013. |
| 24367955 | Background | Rao AK, Chou A, Bursley B, Smulofsky J, Jezequel J. Systematic review of the effects of exercise on activities of daily living in people with Alzheimer's disease. Am J Occup Ther. 2014 Jan-Feb;68(1):50-6. doi: 10.5014/ajot.2014.009035. |
| 25318545 | Background | Walker JM, Klakotskaia D, Ajit D, Weisman GA, Wood WG, Sun GY, Serfozo P, Simonyi A, Schachtman TR. Beneficial effects of dietary EGCG and voluntary exercise on behavior in an Alzheimer's disease mouse model. J Alzheimers Dis. 2015;44(2):561-72. doi: 10.3233/JAD-140981. |
| 23934585 | Background | Dufour CA, Marquine MJ, Fazeli PL, Henry BL, Ellis RJ, Grant I, Moore DJ; HNRP Group. Physical exercise is associated with less neurocognitive impairment among HIV-infected adults. J Neurovirol. 2013 Oct;19(5):410-7. doi: 10.1007/s13365-013-0184-8. Epub 2013 Aug 10. |
| 24554483 | Background | Fazeli PL, Woods SP, Heaton RK, Umlauf A, Gouaux B, Rosario D, Moore RC, Grant I, Moore DJ; HNRP Group. An active lifestyle is associated with better neurocognitive functioning in adults living with HIV infection. J Neurovirol. 2014 Jun;20(3):233-42. doi: 10.1007/s13365-014-0240-z. Epub 2014 Feb 20. |
| 16942453 | Background | Fillipas S, Oldmeadow LB, Bailey MJ, Cherry CL. A six-month, supervised, aerobic and resistance exercise program improves self-efficacy in people with human immunodeficiency virus: a randomised controlled trial. Aust J Physiother. 2006;52(3):185-90. doi: 10.1016/s0004-9514(06)70027-7. |
| 24307964 | Background | Mapstone M, Hilton TN, Yang H, Guido JJ, Luque AE, Hall WJ, Dewhurst S, Shah K. Poor Aerobic Fitness May Contribute to Cognitive Decline in HIV-infected Older Adults. Aging Dis. 2013 Aug 27;4(6):311-9. doi: 10.14336/AD.2013.0400311. eCollection 2013. |
| 24072548 | Background | Mattson MP. Exercise and the brain: a slap on the HAND. J Neurovirol. 2013 Oct;19(5):407-9. doi: 10.1007/s13365-013-0208-4. Epub 2013 Sep 27. No abstract available. |
| 25133835 | Background | Rodrigues AM, O'Brien N, French DP, Glidewell L, Sniehotta FF. The question-behavior effect: genuine effect or spurious phenomenon? A systematic review of randomized controlled trials with meta-analyses. Health Psychol. 2015 Jan;34(1):61-78. doi: 10.1037/hea0000104. Epub 2014 Aug 18. |
| 24929842 | Background | Gill AJ, Kolson DL. Chronic inflammation and the role for cofactors (hepatitis C, drug abuse, antiretroviral drug toxicity, aging) in HAND persistence. Curr HIV/AIDS Rep. 2014 Sep;11(3):325-35. doi: 10.1007/s11904-014-0210-3. |
| 1462174 | Background | Rosenfield PL. The potential of transdisciplinary research for sustaining and extending linkages between the health and social sciences. Soc Sci Med. 1992 Dec;35(11):1343-57. doi: 10.1016/0277-9536(92)90038-r. |
| 19372436 | Background | Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009 May 12;180(10):E47-57. doi: 10.1503/cmaj.090523. Epub 2009 Apr 16. No abstract available. |
| 24715492 | Background | Masters MC, Ances BM. Role of neuroimaging in HIV-associated neurocognitive disorders. Semin Neurol. 2014 Feb;34(1):89-102. doi: 10.1055/s-0034-1372346. Epub 2014 Apr 8. |
| 40965137 | Derived | Cooley SA, Ferreiro A, Nelson B, Sukhum K, Westerhaus E, Petersen K, Fox JR, Rosenow A, Sorensen C, Vaida F, Reeds DN, Tarr PI, Dantas G, Ances BM. A randomized controlled trial to unveil the influence of an exercise intervention on brain integrity and gut microbiome structure in individuals with HIV. AIDS. 2026 Jan 1;40(1):24-34. doi: 10.1097/QAD.0000000000004346. Epub 2025 Sep 17. |
| 36943345 | Derived | Cooley S, Nelson BM, Rosenow A, Westerhaus E, Cade WT, Reeds DN, Vaida F, Yarasheski KE, Paul RH, Ances BM. Exercise Training to Improve Brain Health in Older People Living With HIV: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 21;12:e41421. doi: 10.2196/41421. |
| BG001 | Social Interaction Stretching (SIS) | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. Stretching and Social Interaction: Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Mean | Standard Deviation | years |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Viral Load Undetectable (<50 copies/mL) | An undetectable viral load is currently recognized as HIV-1 RNA viral load <50 copies/mL. This means there are less than 50 copies of the virus present in a blood sample. This measure is stating how many participants were currently undetectable at the time of enrollment into the study. | Count of Participants | Participants |
|
| Median recent CD4 T-cell count (cells/mm3) (IQR) | CD4 T cells are a type of lymphocyte. CD4 T lymphocytes (CD4 cells) help coordinate the immune response by stimulating other immune cells, such as macrophages, B lymphocytes (B cells), and CD8 T lymphocytes (CD8 cells), to fight infection. HIV weakens the immune system by destroying CD4 cells. The median recent CD4 T-Cell count is the value separating the higher half from the lower half of a data sample. | Median | Inter-Quartile Range | cells/mm3 |
|
| Median CD4 nadir T-cell count (cells/mm3) (IQR) | CD4 Nadir refers to the lowest historical value for CD4 T cell count. Research has shown that a Nadir CD4 T-cell count is a predictor of negative outcomes in HIV -infected patients. The median CD4 Nadir is the value separating the higher half from the lower half the data sample. | Median | Inter-Quartile Range | cells/mm3 |
|
| Median CD8 T-cell count (cells/mm3) (IQR) | CD8 T cells are an indication of active HIV infection. The lower the CD8 the less active virus is in the system. The median is the value separating the higher half from the lower half of a data sample. | Median | Inter-Quartile Range | cells/mm3 |
|
| Mean duration of HIV infection (in months) (SD) | Mean | Standard Deviation | Months of Infection |
|
| OG001 | Social Interaction Stretching (SIS) | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the Exercise group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the Exercise program. These Stretching participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the Exercise classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. Stretching and Social Interaction: Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the Exercise program. |
|
|
|
| Primary | Changes in Brain Structural/Functional Measures in Older PLWH | The Investigators will assess if an EXS program improves brain structure and function more than a SIS program in older sedentary PLWH. Changes in brain volumetrics (total cortex volume) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups. | Participants from both the Exercise and Stretching group's MRIs were analyzed for cortical volume change from pre-intervention to post-intervention. | Posted | Mean | Standard Deviation | mm^3 | 26 weeks |
|
|
|
|
| Primary | Change in Level of Daily Activity | Investigators will examine the amount of change in daily activity based on 7-day actigraphy at baseline and then again at follow-up (26 weeks later). Daily activity is measured using an actigraph that participants wear on their wrist and it measures the amount of time spent in sedentary, slightly active, moderately active, vigorously active or very vigorously active categories. | Posted | Mean | Standard Deviation | Average Minutes per Day | 6 Months |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Social Interaction Stretching (SIS) | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. Stretching and Social Interaction: Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
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 |
| D001519 | Behavior |
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
| .02 |
| Slope |
| 0.41 |
| 1-Sided |
| 95 |
| Other |
| Changes in Brain Volumes associated with changes Memory Performance in EXS | Regression, Linear | 0.02 | Slope | 0.40 | 1-Sided | 95 | Other |