Cooley Sarah, Nelson Brittany M, Rosenow Alexander, Westerhaus Elizabeth, Cade W Todd, Reeds Dominic N, Vaida Florin, Yarasheski Kevin E, Paul Robert H, Ances Beau M
Department of Neurology, School of Medicine, Washington University in St. Louis, Saint Louis, MO, United States.
Doctor of Physical Therapy Division, Duke University School of Medicine, Durham, NC, United States.
JMIR Res Protoc. 2023 Mar 21;12:e41421. doi: 10.2196/41421.
With the advent of antiretrovirals, people living with HIV are living near-normal lifespans. However, people living with HIV are at greater risk of experiencing cognitive impairment and reduced brain integrity despite well-controlled viremia. A robust literature supports exercise interventions as a method of improving cognition and structural brain integrity in older individuals without HIV. The effects of exercise on cardiometabolic, neurocognitive, and neural structures in middle-aged to older people living with HIV are less well known, with few prospective studies examining these measures.
This prospective randomized clinical trial will examine the effects of a 6-month exercise training intervention compared to a 6-month stretching intervention (control) on cardiorespiratory fitness, physical function and strength, cognition, and neuroimaging measures of brain volumes and cerebral blood flow in people living with HIV.
Sedentary middle-aged to older people living with HIV (ages≥40; n=150) with undetectable HIV viral load (<20 copies/mL) will be enrolled in the study. At the baseline and final visit, fasting plasma lipid, insulin, glucose, and brain neurotrophic factor concentrations; cardiorespiratory fitness; cognitive performance; brain volumes; and cerebral blood flow via a magnetic resonance imaging scan will be measured. Participants will be randomized in a 2:1 ratio to either the exercise or control stretching intervention. All participants will complete their assigned programs at a community fitness center 3 times a week for 6 months. A professional fitness trainer will provide personal training guidance at all sessions for individuals enrolled in both arms. Individuals randomized to the exercise intervention will perform endurance and strength training exercises, while those randomized to the control intervention will perform stretches to increase flexibility. A midpoint visit (at 3 months) will assess cognitive performance, and at the end point visit, subjects will undergo cardiorespiratory fitness and cognition testing, and a magnetic resonance imaging scan. Physical activity throughout the duration of the trial will be recorded using an actigraph.
Recruitment and data collection are complete as of December 2020. Data processing, cleaning, and organization are complete as of December 2021. Data analysis began in January 2022, with the publication of study results for primary aims 1 and 2 expected by early 2023.
This study will investigate the effects of a 6-month aerobic and resistance exercise training intervention to improve cardiometabolic risk factors, cognitive performance, cerebral structure, and blood flow in sedentary people living with HIV. Results will inform clinicians and patients of the potential benefits of a structured aerobic exercise training program on the cognitive, functional, and cardiometabolic health status of older people living with HIV. Assessment of compliance will inform the development and implementation of future exercise programs for people living with HIV.
ClinicalTrials.gov NCT02663934; https://clinicaltrials.gov/ct2/show/NCT02663934.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41421.
随着抗逆转录病毒药物的出现，感染艾滋病毒的人寿命接近正常。然而，尽管病毒血症得到了良好控制，但感染艾滋病毒的人仍面临更高的认知障碍风险和脑完整性下降的问题。大量文献支持运动干预作为改善未感染艾滋病毒的老年人认知和脑结构完整性的一种方法。运动对中年及老年艾滋病毒感染者的心脏代谢、神经认知和神经结构的影响鲜为人知，很少有前瞻性研究对此进行检测。
这项前瞻性随机临床试验将研究为期6个月的运动训练干预与为期6个月的伸展干预（对照）相比，对艾滋病毒感染者的心肺适能、身体功能和力量、认知以及脑容量和脑血流量的神经影像学测量的影响。
招募久坐不动的中年及老年艾滋病毒感染者（年龄≥40岁；n = 150），其艾滋病毒病毒载量检测不到（<20拷贝/mL）。在基线和末次访视时，测量空腹血浆脂质、胰岛素、葡萄糖和脑源性神经营养因子浓度；心肺适能；认知表现；脑容量；以及通过磁共振成像扫描测量脑血流量。参与者将按2:1的比例随机分配到运动或对照伸展干预组。所有参与者将在社区健身中心每周进行3次指定项目，持续6个月。专业健身教练将在所有课程中为两组参与者提供个人训练指导。随机分配到运动干预组的个体将进行耐力和力量训练运动，而随机分配到对照干预组的个体将进行伸展运动以增加灵活性。在3个月时进行中期访视，评估认知表现，在终点访视时，受试者将接受心肺适能和认知测试以及磁共振成像扫描。使用活动记录仪记录整个试验期间的身体活动情况。
截至2020年12月，招募和数据收集工作已完成。截至2021年12月，数据处理、清理和整理工作已完成。数据分析于2022年1月开始，预计2023年初公布主要目标1和2的研究结果。
本研究将调查为期6个月的有氧和阻力运动训练干预对改善久坐不动的艾滋病毒感染者的心脏代谢危险因素、认知表现、脑结构和血流量的影响。研究结果将告知临床医生和患者结构化有氧运动训练计划对老年艾滋病毒感染者的认知、功能和心脏代谢健康状况的潜在益处；对依从性的评估将为未来艾滋病毒感染者运动计划的制定和实施提供参考。
ClinicalTrials.gov NCT02663934；https://clinicaltrials.gov/ct2/show/NCT02663934。
国际注册报告识别码（IRRID）：DERR1-10.2196/41421。
