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

HIV Clinical Trial

Official title: Soluble Insulin Receptor Dysfunction Correlates With HAND in HIV+ Women on CART

Status Recruiting

Clinical 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, 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.

Clinical Trial 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-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

• NCT number: NCT02962622
• Study type: Interventional
• Source: University of Puerto Rico
• Contact: Farah A. Ramirez-Marrero, PhD
• Phone: 787-602-0088
• Email: farah.ramirez1@upr.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Completion date: December 2017