HIVEx/HIVNCT02663934
Exercise Training to Improve Brain Health in Older HIV+ Individuals
A study testing Exercise and Stretching and Social Interaction in people with HIV, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Exercise and Stretching and Social Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 30 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 40 years old
- documented history of HIV infection
- on stable combination antiretroviral therapy (cART) for approximately 3 months with undetectable plasma HIV RNA
- physically inactive-sedentary lifestyle (approximately <2 hours of exercise/week) and not engaged in regular exercise for approximately 3 months prior to enrollment
- approximately 9 years of education
- able to have an MRI
- able to provide written informed consent (does not have LAR, POA, etc.)
Who cannot join
- approximately >2x/week of moderate (or greater) exercise
- cardiovascular/cerebrovascular disease or pulmonary disease that precludes ability to safely exercise
- significant neurological disorders (e.g. stroke, head injury with loss of consciousness for >30 minutes, developmental learning disability
- presence of dementia or behavioral disorders that would prevent ability to follow the protocol
- alcohol or substance abuse/ dependence within the last 6 months (DSM-4 TR)
- contraindications to MRI scanning (e.g. claustrophobia, pacemaker)
- pregnant or breast-feeding
- unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Exercise, Stretching and Social Interaction
- Keywords
- HIV, AIDS, Cognition, Memory, Exercise, Stretching
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
Stretching and Social InteractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| 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. Receives: Behavioral: Stretching and Social Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startAug 2016
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: COVID-19 Risk
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.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, St. Louis, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Beau M Ances, MD,PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663934
- Sponsor's protocol ID
- 201508002
- Acronym
- Ex/HIV
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2016
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data will be shared when the study has closed.
Publications
Spudich S. HIV and neurocognitive dysfunction. Curr HIV/AIDS Rep. 2013 Sep;10(3):235-43. doi: 10.1007/s11904-013-0171-y.
PubMed 23860944Spudich 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.
PubMed 22675662Clifford DB, Ances BM. HIV-associated neurocognitive disorder. Lancet Infect Dis. 2013 Nov;13(11):976-86. doi: 10.1016/S1473-3099(13)70269-X.
PubMed 24156898Shah S, Mildvan D. HIV and aging. Curr Infect Dis Rep. 2006 May;8(3):241-7. doi: 10.1007/s11908-006-0065-x.
PubMed 16643776Valcour 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.
PubMed 16619159Hall 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.
PubMed 18677024Ortega 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.
PubMed 24816714Xu 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.
PubMed 19016329Cohen 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.
PubMed 25848401Desquilbet 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.
PubMed 21719610Justice 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.
PubMed 20425560Justice 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.
PubMed 19751364Onen 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.
PubMed 19706308Casau 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.
PubMed 16107986Ngandu 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.
PubMed 25771249
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training to Improve Brain Health in Older HIV+ Individuals
- ClinicalTrials.gov ID
- NCT02663934
- Acronym / sponsor ID
- Ex/HIV / 201508002
- Conditions
- HIV
- Keywords
- HIV, AIDS, Cognition, Memory, Exercise, Stretching
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Risk
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Missouri, St. Louis, University of California, San Diego
- Study start
- Aug 2016 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise (EXS) | Experimental | Behavioral: ExerciseAll 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 | Behavioral: Stretching and Social InteractionThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age > 40 years old
- documented history of HIV infection
- on stable combination antiretroviral therapy (cART) for approximately 3 months with undetectable plasma HIV RNA
- physically inactive-sedentary lifestyle (approximately <2 hours of exercise/week) and not engaged in regular exercise for approximately 3 months prior to enrollment
- approximately 9 years of education
Key exclusion criteria (8 listed)
- approximately >2x/week of moderate (or greater) exercise
- cardiovascular/cerebrovascular disease or pulmonary disease that precludes ability to safely exercise
- significant neurological disorders (e.g. stroke, head injury with loss of consciousness for >30 minutes, developmental learning disability
- presence of dementia or behavioral disorders that would prevent ability to follow the protocol
- alcohol or substance abuse/ dependence within the last 6 months (DSM-4 TR)
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 |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise (EXS) |
| Stretching and Social InteractionParticipants 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. | Behavioural | Social Interaction Stretching (SIS) |
Primary outcome
Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group
Time frame: 6 months
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.
Changes in Brain Structural/Functional Measures in Older PLWH
Time frame: 26 weeks
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.
Change in Level of Daily Activity
Time frame: 6 Months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23860944Spudich S. HIV and neurocognitive dysfunction. Curr HIV/AIDS Rep. 2013 Sep;10(3):235-43. doi: 10.1007/s11904-013-0171-y.
- Background: PubMed 22675662Spudich 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.
- Background: PubMed 24156898Clifford DB, Ances BM. HIV-associated neurocognitive disorder. Lancet Infect Dis. 2013 Nov;13(11):976-86. doi: 10.1016/S1473-3099(13)70269-X.
- Background: PubMed 16643776Shah S, Mildvan D. HIV and aging. Curr Infect Dis Rep. 2006 May;8(3):241-7. doi: 10.1007/s11908-006-0065-x.
- Background: PubMed 16619159Valcour 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.
- Background: PubMed 18677024Hall 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.
- Background: PubMed 24816714Ortega 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.
- Background: PubMed 19016329Xu 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.
- Background: PubMed 25848401Cohen 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.
- Background: PubMed 21719610Desquilbet 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.
- Background: PubMed 20425560Justice 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.
- Background: PubMed 19751364Justice 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.
- Individual participant dataSharing planned: Undecided. Data will be shared when the study has closed.
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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.
Beau M Ances, MD,PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Stretching and Social Interaction in people with HIV, run by Washington University School of Medicine at 1 site 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 21 Nov 2023). 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?
Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663934, which also lists 32 linked publications.
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 21 Nov 2023.