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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
22 Sep 2020
Historique:
received: 13 04 2020
accepted: 08 09 2020
entrez: 23 9 2020
pubmed: 24 9 2020
medline: 22 6 2021
Statut: epublish

Résumé

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.

Sections du résumé

BACKGROUND 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 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 CONCLUSIONS
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 BACKGROUND
ClinicalTrials.gov NCT03840525 . Registered on 16 July 2018.

Identifiants

pubmed: 32962749
doi: 10.1186/s13063-020-04728-x
pii: 10.1186/s13063-020-04728-x
pmc: PMC7506206
doi:

Banques de données

ClinicalTrials.gov
['NCT03840525']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

804

Subventions

Organisme : NCCIH NIH HHS
ID : R34 AT009966
Pays : United States

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Auteurs

Gladys E Ibañez (GE)

Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA. gibanez@fiu.edu.

Kristopher Fennie (K)

Division of Natural Sciences, New College of Florida, 5800 Bay Shore Road, Sarasota, FL, 34243, USA.

Linda Larkey (L)

College of Nursing and Health Innovation, Arizona State University, 550 N 3rd St, Phoenix, AZ, 85004, USA.

Nan Hu (N)

Department of Biostatistics, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.
Division of Public Health, Family and Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, 84132, USA.

Angel B Algarin (AB)

Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.
Division of Infectious Diseases and Global Public Health, University of California San Diego, La Jolla, CA, 92093, USA.

Chelsea Valdivia (C)

Department of Biostatistics, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.

Helen Lavretsky (H)

Department of Psychiatry, Semel Institute for Neuroscience and Human Behavior, The University of California, Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA.

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