CClinicalTrials.gg
Status unknownNCT02962622CMExUpdated Nov 11, 2016

Cognition Metabolism and Exercise Among Women Living With HIV in Puerto Rico

An interventional study of High intensity interval training (HIIT) in HIV, sponsored by University of Puerto Rico. Status unknown at 1 site in Puerto Rico. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by University of Puerto Rico · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
21 Years and older
Sex
Female
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Study 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, 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.

02

Conditions studied

  • HIV

Keywords

  • Neurocognition
  • Exercise
  • Metabolism
  • Hispanic women
03

In context

Lead sponsor

University of Puerto Rico is the lead sponsor of 45 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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).
  2. 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.
  3. 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.
  4. No diagnosis of diabetes or the use of hypoglycemic agents.

Exclusion criteria

Exclusion Criteria:

  1. HIV+ women and men \<21 years old with CD4 cell count >500 cells/mm3 and/or viral load \<1,000 copies/mL.
  2. 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.)
  3. History of diabetes or the use hypoglycemic agents.
  4. 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.
  5. Active systemic infection or illness, which in the judgment of the investigators may affect the study.
  6. Pregnant/nursing mothers or women with recent birth (\<60 days).
  7. 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).
  8. Patients who are unwilling to give informed consent or incapable of understanding informed consent.
  9. Education less than 9th grade.

    -

05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Hispanic women living with HIV

    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.

    Other: High intensity interval training (HIIT)

  • Experimental
    Hispanic women living without HIV

    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.

    Other: High intensity interval training (HIIT)

Interventions

  • OtherHigh intensity interval training (HIIT)

    Six weeks, three days per week (total of 18 sessions) of HIIT cycle ergometer exercise protocol

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What researchers measure

Primary outcomes

  1. Cardio-respiratory fitness as measured by maximal oxygen consumption (VO2max)

    Maximal oxygen consumption

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

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Study locations

1 of 1 sites recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02962622
Lead sponsor
University of Puerto Rico
Responsible party
Farah A. Ramirez-Marrero (Professor, University of Puerto Rico) — Principal investigator
First posted
Nov 11, 2016
Start date
Nov 2014
Primary completion
Jun 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Nov 11, 2016

Study contacts

Farah A. Ramirez-Marrero, PhD
Contact
farah.ramirez1@upr.edu
787-602-0088
Valerie Wojna-Muniz, MD
Contact
valerie.wojna1@upr.edu
787-758-2525 ext. 2819
Farah A. Ramirez-Marrero, PhD
principal investigator · University of Puerto Rico

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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