JMIR Publications

ABSTRACT

Background:

The introduction of antiretroviral therapy (ART) has led to a drastic fall in the incidence of HIV-associated dementia. However, less severe but limiting forms of HIV-associated neurocognitive disorder (HAND) continues to be prevalent even with the use of ART. Aerobic exercise, a behavioural intervention may be a beneficial and effective complement to ART in the management of HAND. In HIV-negative individuals, aerobic exercise mitigates pathogenic changes similar to those of HAND.

Objective:

This protocol describes a randomized clinical trial designed to determine the effect of a 12-week aerobic exercise programme on HAND in Southeastern Nigeria.

Methods:

A minimum of seventy-six patients diagnosed with HAND will be randomized into aerobic exercise and control groups. Aerobic exercise will be carried out on a stationary bicycle ergometer at moderate intensity, three times a week for 12-weeks. Primary outcomes are neurocognitive performance, CD4-count and viral load. Evaluation of post-exercise neurocognitive performance will be undertaken using reliable neuropsychological tests relevant to PLWHIV, in line with Frascati criteria. Secondary outcomes such as quality of life, and activity limitation and social participation will be assessed using the WHOQOL-Bref, and the Oxford Participation and Activities questionnaire respectively. Data will be subjected to exploratory statistics to test for normality and homogeneity. The effect of the exercise programme on HAND will be analysed using two-way repeated-measures ANOVA, with Bonferroni’s correction. Within-group comparison will be undertaken using paired sampled t-test.

Results:

Enrollment began on 18th January 2021. Recruitment has been completed. The trial is ongoing and will be completed in July 2021

Conclusions:

The study will provide valuable information about the effect of aerobic exercise on HAND thus verifying the suitability of aerobic exercise as a complementary therapy for mitigating neurocognitive disorder among PLWHIV. Data from the study will be useful in pursuit of debate on the necessity of a sponsored rehabilitation arm in ART clinics. Clinical Trial: The study was registered with the PAN African Trial Registry (PACTR) on the 1stth September 2020. The registration ID is PACTR202009483415745.