HIVCMExNCT02962622
Cognition Metabolism and Exercise Among Women Living With HIV in Puerto Rico
A study testing High intensity interval training (HIIT) in people with HIV, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The study evaluates the association between soluble insulin receptor dysfunction, cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who volunteer to participate in the study will have two evaluations at study entry that include a dual x-ray absorptiometry (DEXA) densitometry… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- High intensity interval training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Nov 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-seropositive women ≥21 years with lymphocytes differentiated cells 4 (CD4) cell count or nadir in the last year ≤500 cells/mm3, or viral load ≥1,000 copies/mL despite highly active antiretroviral therapy (HAART).
- Education level ≥9th grade, since is the minimum required for some of the neuro-psychological (NP) tests. All HIV-seropositive and HIV-seronegative participants will be tested for vocabulary and reading pre-morbid cognitive function as described below.
- Non-drug abusers; defined as those with <5 exposures in a lifetime to drugs (opiates/heroin, methamphetamine, cocaine/crack, speed ball). For the purpose of this study neither tobacco nor nicotine use will be considered a drug.
- No diagnosis of diabetes or the use of hypoglycemic agents.
Who cannot join
- HIV+ women and men <21 years old with CD4 cell count >500 cells/mm3 and/or viral load <1,000 copies/mL.
- Opportunistic infections of the central nervous system (CNS) as determined by neurological evaluation and neuroimaging. (Neuroimaging studies, if needed, will be performed as part of patient care and hence have not been included as a budget item in this proposal.)
- History of diabetes or the use hypoglycemic agents.
- Underlying neurologic and/or neuropsychiatric disorders such as cerebrovascular events; history of meningitis/encephalitis, CNS opportunistic infections, or seizures; head trauma (<6 months with loss of consciousness for >1 hr); cerebral palsy; or any other neuropsychiatric condition that in the judgment of the investigators may affect the study.
- Active systemic infection or illness, which in the judgment of the investigators may affect the study.
- Pregnant/nursing mothers or women with recent birth (<60 days).
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- Substance abuse: active drug use - all participants will be screened with urine toxicology and active alcohol abuse - those scoring >3 points in the Michigan Alcoholism Screening Test (MAST) will be screened with blood samples for alcohol levels (Seltzer 1975).
- Patients who are unwilling to give informed consent or incapable of understanding informed consent.
- Education less than 9th grade.
- -
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site, 1 recruiting
- Recruiting
Medical Sciences Campus
San Juan, 00936
Farah A. Ramirez-Marrero, PhD, 787-602-0088, farah.ramirez1@upr.edu
Valerie Wojna-Muniz, MD, 787-758-252 ext. 2819, valerie.wojna1@upr.edu
About this study
Official title: Soluble Insulin Receptor Dysfunction Correlates With HAND in HIV+ Women on CART
The study evaluates the association between soluble insulin receptor dysfunction, cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who volunteer to participate in the study will have two evaluations at study entry that include a dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing, blood and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA will be conducted in the Endocrinology Unit at the University Hospital, Medical Center (letter of support included). The cardiorespiratory fitness testing will be conducted in the AIDS Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences Campus, and the Puerto Rico Clinical and Translational Research Consortium. Then, participants will be invited to participate in a 6-week, 3 days/week individualized exercise program. The exercise program will be conducted at the University of Puerto Rico Medical Sciences Campus. After completion of the exercise program, study entry evaluations will be repeated. The duration of the study will take approximately 10 weeks.
Read the detailed description
The aim of the study is to determine the effect of a low volume high intensity interval training (HIIT) exercise intervention on cardio-respiratory fitness (CR-fitness), insulin resistance, and cognitive function among normally active but physically untrained HIV+ Hispanic women. The primary hypotheses are that HIIT will improve: 1) CR-fitness in all groups (HIV+ and HIV-), 2) insulin sensitivity in both groups of HIV+ women, and 3) cognitive function as determined by hippocampal function in HIV+ women with HAND. Participants will receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. Then, participants will be evaluated with a CR-fitness, insulin resistance, anthropometry, and neurocognitive function tests.
Participants will undergo an intervention (described above) designed for normally active but physically untrained HIV+ Hispanic women, one with (n=15) and other without (n=15) neurocognitive impairment \& HIV- controls (n=15). After the HIIT intervention, measurements of CR-fitness, insulin resistance, and cognitive function including hippocampal function using the memory island test will be obtained, as well as CR-fitness, anthropometry, DEXA densitometry, and blood and urine samples for metabolic testing. The ultimate goal is to improve the understanding of mechanisms by which exercise influence neurocognitive function; thus, providing a potential non-pharmacological alternative to prevent, control or reduce chronic incapacitating diseases in HIV+ Hispanic adults.
- Conditions
- HIV
- Being tested
- High intensity interval training (HIIT)
- Keywords
- Neurocognition, Exercise, Metabolism, Hispanic women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training (HIIT)Other
Six weeks, three days per week (total of 18 sessions) of HIIT cycle ergometer exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| Hispanic women living with HIV | Experimental | High intensity interval training (HIIT) on normally active but physically untrained HIV+ Hispanic women, one with (n=15) and other without (n=15) neuro-cognitive impairment (HAND) on antiretroviral therapy (CART) receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. Receives: Other: High intensity interval training (HIIT) |
| Hispanic women living without HIV | Experimental | High intensity interval training (HIIT) on a comparison group of 15 Hispanic women without HIV receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. Receives: Other: High intensity interval training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-respiratory fitness as measured by maximal oxygen consumption (VO2max)
Maximal oxygen consumption
Measured: 6 weeks
Secondary outcomes (2)
Metabolic syndrome classification based on the National Cholesterol Education Program (NCEP) criteria
Number of participants with abnormal values in 3 or more of the following: fasting glucose, resting blood pressure, waist circumference, fasting triglycerides, and HDL.
Measured: 6 weeks
Neurocognitive function as measured by memory testing
Number of participants with abnormal values of neurocognitive function will be identified. Measures of memory testing using questionnaires and a computer-based assessment will be aggregated to arrive at one reported value of neurocognitive function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah A. Ramirez-Marrero, University of Puerto Rico
- Investigators
- Farah A. Ramirez-Marrero, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962622
- Sponsor's protocol ID
- UPuertoRico
- Acronym
- CMEx
- Status last verified
- Nov 2016
- First submitted
- 5 Oct 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ramirez-Marrero FA, Perez-Frontera S, Amalbert-Birriel MA, Matos M, Santana-Bagur J, Frontera WR, Wojna V. Brief Report: Effects of Low-Volume High-Intensity Interval Training in Hispanic HIV+ Women: A Nonrandomized Study. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):285-289. doi: 10.1097/QAI.0000000000002353.
PubMed 32530906
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Insulin Receptor Dysfunction Correlates With HAND in HIV+ Women on CART
- ClinicalTrials.gov ID
- NCT02962622
- Acronym / sponsor ID
- CMEx / UPuertoRico
- Conditions
- HIV
- Keywords
- Neurocognition, Exercise, Metabolism, Hispanic women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the association between soluble insulin receptor dysfunction, cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who volunteer to participate in the study will have two evaluations at study entry that include a dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing, blood and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA will be conducted in the Endocrinology Unit at the University Hospital, Medical Center (letter of support included). The cardiorespiratory fitness testing will be conducted in the AIDS Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences Campus, and the Puerto Rico Clinical and Translational Research Consortium. Then, participants will be invited to participate in a 6-week, 3 days/week individualized exercise program. The exercise program will be conducted at the University of Puerto Rico Medical Sciences Campus. After completion of the exercise program, study entry evaluations will be repeated. The duration of the study will take approximately 10 weeks.
Detailed description
The aim of the study is to determine the effect of a low volume high intensity interval training (HIIT) exercise intervention on cardio-respiratory fitness (CR-fitness), insulin resistance, and cognitive function among normally active but physically untrained HIV+ Hispanic women. The primary hypotheses are that HIIT will improve: 1) CR-fitness in all groups (HIV+ and HIV-), 2) insulin sensitivity in both groups of HIV+ women, and 3) cognitive function as determined by hippocampal function in HIV+ women with HAND. Participants will receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. Then, participants will be evaluated with a CR-fitness, insulin resistance, anthropometry, and neurocognitive function tests.
Participants will undergo an intervention (described above) designed for normally active but physically untrained HIV+ Hispanic women, one with (n=15) and other without (n=15) neurocognitive impairment \& HIV- controls (n=15). After the HIIT intervention, measurements of CR-fitness, insulin resistance, and cognitive function including hippocampal function using the memory island test will be obtained, as well as CR-fitness, anthropometry, DEXA densitometry, and blood and urine samples for metabolic testing. The ultimate goal is to improve the understanding of mechanisms by which exercise influence neurocognitive function; thus, providing a potential non-pharmacological alternative to prevent, control or reduce chronic incapacitating diseases in HIV+ Hispanic adults.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hispanic women living with HIV | Experimental | Other: High intensity interval training (HIIT)High intensity interval training (HIIT) on normally active but physically untrained HIV+ Hispanic women, one with (n=15) and other without (n=15) neuro-cognitive impairment (HAND) on antiretroviral therapy (CART) receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. |
| Hispanic women living without HIV | Experimental | Other: High intensity interval training (HIIT)High intensity interval training (HIIT) on a comparison group of 15 Hispanic women without HIV receive 2 weeks, 6 sessions of 8 x 60 seconds cycling bouts eliciting approximately 80% of maximal heart rate with 60 second rest between bouts after which they will receive 4 week, 12 sessions of 10 x 60 seconds cycling bouts eliciting approximately 90% of maximal heart rate with 60 second rest between bouts. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-seropositive women ≥21 years with lymphocytes differentiated cells 4 (CD4) cell count or nadir in the last year ≤500 cells/mm3, or viral load ≥1,000 copies/mL despite highly active antiretroviral therapy (HAART).
- Education level ≥9th grade, since is the minimum required for some of the neuro-psychological (NP) tests. All HIV-seropositive and HIV-seronegative participants will be tested for vocabulary and reading pre-morbid cognitive function as described below.
- Non-drug abusers; defined as those with <5 exposures in a lifetime to drugs (opiates/heroin, methamphetamine, cocaine/crack, speed ball). For the purpose of this study neither tobacco nor nicotine use will be considered a drug.
- No diagnosis of diabetes or the use of hypoglycemic agents.
Key exclusion criteria (10 listed)
- HIV+ women and men <21 years old with CD4 cell count >500 cells/mm3 and/or viral load <1,000 copies/mL.
- Opportunistic infections of the central nervous system (CNS) as determined by neurological evaluation and neuroimaging. (Neuroimaging studies, if needed, will be performed as part of patient care and hence have not been included as a budget item in this proposal.)
- History of diabetes or the use hypoglycemic agents.
- Underlying neurologic and/or neuropsychiatric disorders such as cerebrovascular events; history of meningitis/encephalitis, CNS opportunistic infections, or seizures; head trauma (<6 months with loss of consciousness for >1 hr); cerebral palsy; or any other neuropsychiatric condition that in the judgment of the investigators may affect the study.
- Active systemic infection or illness, which in the judgment of the investigators may affect the study.
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 |
|---|---|---|
| High intensity interval training (HIIT)Six weeks, three days per week (total of 18 sessions) of HIIT cycle ergometer exercise protocol | Other | Hispanic women living with HIV, Hispanic women living without HIV |
Primary outcome
Cardio-respiratory fitness as measured by maximal oxygen consumption (VO2max)
Time frame: 6 weeks
Maximal oxygen consumption
2 secondary outcomes
Metabolic syndrome classification based on the National Cholesterol Education Program (NCEP) criteria
Time frame: 6 weeks
Neurocognitive function as measured by memory testing
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Derived from this study: PubMed 32530906Ramirez-Marrero FA, Perez-Frontera S, Amalbert-Birriel MA, Matos M, Santana-Bagur J, Frontera WR, Wojna V. Brief Report: Effects of Low-Volume High-Intensity Interval Training in Hispanic HIV+ Women: A Nonrandomized Study. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):285-289. doi: 10.1097/QAI.0000000000002353.
- Individual participant dataSharing planned: Undecided
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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.
Farah A. Ramirez-Marrero, PhD principal investigator
University of Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training (HIIT) in people with HIV, run by University of Puerto Rico at 1 site in Puerto Rico.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. 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 Puerto Rico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farah A. Ramirez-Marrero, PhD (787-602-0088, farah.ramirez1@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-respiratory fitness as measured by maximal oxygen consumption (VO2max) (time frame: 6 weeks). 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 NCT02962622, which also lists 1 linked publication.
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 11 Nov 2016.