Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.
Division of Natural Sciences, New College of Florida, 5800 Bay Shore Road, Sarasota, FL, 34243, USA.
Trials. 2020 Sep 22;21(1):804. doi: 10.1186/s13063-020-04728-x.
Almost half of people living with HIV (PLWH) in the USA are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physical symptoms combined, both prevalent in this population. There is a need to find innovative and accessible interventions that can help older PLWH to manage their symptoms. Mind-body interventions, like tai chi/qigong (TCQ), improve both physical and psychological health. TCQ is a series of slow, low-impact meditative movements that integrates breathwork, meditation, and stances.
The present study is an exploratory clinical trial that will evaluate the acceptability and feasibility of a 12-week, small group TCQ intervention (n = 24), a sham qigong control condition (n = 24), and a standard of care control condition (n = 24) for older people living with HIV/AIDS. It will also explore any preliminary associations between the TCQ intervention and symptom alleviation. Participants will be recruited from community-based health and social services organizations in Miami, FL, and randomized to one of the 3 conditions.
We will assess feasibility and acceptability through questionnaires and adherence to TCQ. We will assess preliminary associations with symptoms such as depression, anxiety, social support, chronic HIV-related fatigue, and clinical outcomes. These will be described through proportions, means, and changes over time through graphing techniques. Outcomes will be assessed at baseline, at post-intervention, and at 3 months follow-up. These preliminary analyses also will provide information necessary to estimate effect size and power needed for a larger clinical trial.
ClinicalTrials.gov NCT03840525 . Registered on 16 July 2018.
美国近一半的艾滋病毒感染者(PLWH)年龄在 50 岁以上;预计到 2020 年,这一比例将增至 70%。然而,针对这一人群中普遍存在的心理和生理症状,几乎没有针对老年 PLWH 的干预措施。因此,需要寻找创新且易于接受的干预措施,帮助老年 PLWH 管理其症状。身心干预措施,如太极/气功(TCQ),可以改善身心健康。TCQ 是一系列缓慢、低冲击的冥想运动,融合了呼吸、冥想和姿势。
本研究是一项探索性临床试验,旨在评估为期 12 周的小组 TCQ 干预(n=24)、假气功对照条件(n=24)和标准护理对照条件(n=24)对老年艾滋病毒/艾滋病患者的可接受性和可行性。它还将探讨 TCQ 干预与症状缓解之间的任何初步关联。参与者将从佛罗里达州迈阿密的社区健康和社会服务组织招募,并随机分配到 3 个条件之一。
我们将通过问卷和 TCQ 的依从性来评估可行性和可接受性。我们将评估与抑郁、焦虑、社会支持、慢性 HIV 相关疲劳和临床结果等症状的初步关联。这些将通过比例、平均值和通过图形技术随时间的变化来描述。结果将在基线、干预后和 3 个月随访时进行评估。这些初步分析还将提供必要的信息,以估计更大临床试验所需的效应大小和功效。
ClinicalTrials.gov NCT03840525。于 2018 年 7 月 16 日注册。