A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial.
Gladys E. Ibañez, Kristopher Fennie, Linda Larkey, Nan Hu, Angel B Algarin, Chelsea Valdivia, Helen Lavretsky
Trials September 22, 2020 DOI: 10.1186/s13063-020-04728-x (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical protocol Randomized Peer reviewed |
|---|---|
| Sample size | 72 |
| Population | Older people living with HIV/AIDS, recruited from community-based health and social services organizations in Miami, FL |
| Interventions | Tai chi/qigong (TCQ) sham qigong |
| Duration | 12-week intervention; outcomes assessed at baseline, post-intervention, and 3 months follow-up |
| Keywords | Humans Hiv infections Tai ji Quality of life Aged Mind-body therapies Qigong Intervention Older adults Tai chi |
| Registration | NCT03840525 |
| Key points | The paper outlines a planned exploratory trial to assess the acceptability and feasibility of a 12-week tai chi/qigong intervention for older adults living with HIV, compared with sham qigong and standard care, and to explore preliminary associations with symptoms such as depression, anxiety, social support, and chronic HIV-related fatigue. The authors propose that results will inform effect size and power estimates for a larger trial. |
Abstract
Background: 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.
Methods: 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.
Discussion: 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.
Trial Registration: ClinicalTrials.gov NCT03840525 . Registered on 16 July 2018.