A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial.

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.

Multi-modality human phenotyping to examine subjective and objective health afflictions in former professional American-style football players: The In-Person Assessment (IPA) protocol.

BACKGROUND: Participation in American-style football (ASF), one of the most popular sports worldwide, has been associated with adverse health outcomes. However, prior clinical studies of former ASF players have been limited by reliance on subjective self-reported data, inadequate sample size, or focus on a single disease process in isolation. OBJECTIVE: To determine the burden of objective multi-system pathology and its relationship with subjective health complaints among former professional ASF players. METHODS: The In-Person Assessment is a case-control, multi-day, deep human phenotyping protocol designed to characterize and quantify pathology among former professional ASF players. Participants, recruited from an on-going large-scale longitudinal cohort study, will include 120 men who report either no health conditions, a single health condition, or multiple health conditions across the key domains of cardiometabolic disease, disordered sleep, chronic pain, and cognitive impairment. Data will be collected from validated questionnaires, structured interviews, physical examinations, multi-modality imaging, and functional assessments over a 3-day study period. A pilot study was conducted to assess feasibility and to obtain participant feedback which was used to shape the final protocol. RESULTS: This study provides a comprehensive assessment of objective multi-system pathology and its relationship with subjective health complaints among former professional ASF players. CONCLUSION: The study will determine whether subjective health complaints among former professional ASF players are explained by objective explanatory pathology and will provide novel opportunities to examine the interrelatedness of co-morbidities. It is anticipated that this protocol will be applicable to other clinical and occupational populations.