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

NCT02962622 | Unknown

• 1 other identifier: UPuertoRico
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

Neurocognition; Exercise; Metabolism; Hispanic women

Outcome Measures

Primary Outcomes (1)

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

  Maximal oxygen consumption

  6 weeks

Secondary Outcomes (2)

• Metabolic syndrome classification based on the National Cholesterol Education Program (NCEP) criteria

  6 weeks

• Neurocognitive function as measured by memory testing

  6 weeks

Study Arms (2)

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.

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.

Other: High intensity interval training (HIIT)

Interventions

High intensity interval training (HIIT) OTHER

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

Hispanic women living with HIV; Hispanic women living without HIV

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Medical Sciences Campus

San Juan, 00936, Puerto Rico

RECRUITING

Related Publications (1)

• 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.

  PMID: 32530906 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Farah A. Ramirez-Marrero, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farah A. Ramirez-Marrero, PhD

CONTACT

787-602-0088; farah.ramirez1@upr.edu

Valerie Wojna-Muniz, MD

CONTACT

787-758-2525; valerie.wojna1@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

PR (1)