A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV

NCT ID: NCT03840525

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-09-30

Brief Summary

This study will develop and pilot test a qigong intervention with older people (50 and over) living with HIV. Participants (n=48) will be randomly assigned to one of 3 conditions: the qigong intervention, a sham qigong intervention, and a usual standard of care group. The study will determine the acceptability and feasibility of the study. If found effective, the qigong intervention will also improve the psychological and physical symptoms of older people living with HIV.

Detailed Description

Half of those infected with HIV in the United States are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older people living with HIV/AIDS that address psychological symptoms, and none that address physical symptoms, both of which are prevalent in this population. There is a need to find innovative and accessible interventions that can help older people living with HIV/AIDS to manage their symptoms. Mind-body interventions, like Tai chi and Qi gong (TCQ), improves both physical and psychological health, and might also promote immune functioning. TCQ is a series of slow, low-impact meditative movements that integrates breath work, meditation, and stances. The investigators propose the refinement, adaptation, acceptability and feasibility testing of a standardized TCQ intervention shown efficacious with cancer patients, to an ethnically diverse population of older people living with HIV/AIDS, with the goal of enhancing their ability to manage psychological and physical symptoms. Thus, this study proposes three aims: (i) to refine and culturally adapt a TCQ intervention protocol for a diverse sample of older people living with HIV/AIDS (50 years of age or older); (ii) to evaluate the acceptability and feasibility of the TCQ intervention, a sham qigong control condition, and a standard of care control condition for older people living with HIV/AIDS (n = 48); and (iii) explore any preliminary evidence of efficacy of the TCQ intervention and the control conditions on alleviating physical and psychological symptoms. Participants will be recruited from a federally qualified health center in Miami, Florida. Adaptation of the TCQ intervention, the first aim, will be done through qualitative research. An expert panel discussion, key informant interviews, and three focus groups will be conducted, and analyzed by thematically based content analysis. To address aims 2 and 3, the investigators will conduct a pilot study; participants will be randomized to one of 3 conditions: the TCQ intervention, a sham qigong condition, and a standard of care condition. This is a pilot study to assess feasibility, acceptability, and preliminary efficacy, therefore, analyses will be primarily descriptive. The investigators will assess feasibility and acceptability through questionnaires and adherence to TCQ. The investigators will assess preliminary evidence of efficacy by looking at instruments that measure depression, anxiety, social support, as well as clinical outcomes. These will be described through proportions, means, and changes over time through graphing techniques. Outcomes will be assessed at baseline, post-intervention, and at three months follow up. The investigators will conduct preliminary models that will provide information on estimating effect size and power needed for a larger clinical trial. Note: Due to the coronavirus pandemic, this intervention was adapted from an in-person intervention to a virtual intervention. The intervention is exactly the same except for the difference in delivery method.

Conditions

Mental Health; Physical Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Qigong Intervention

The qigong intervention consists of 1 hour/week qigong classes for 12 weeks to be delivered virtually. The first 2 weeks will include 2 hours/week classes. In addition, each participant will be instructed to practice qigong at home for 90 minutes.

Group Type: EXPERIMENTAL

The Qigong Intervention

Intervention Type: BEHAVIORAL

Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.

Sham Qigong

This group will also have 1 hour/weekly class delivered virtually that includes movements that are similar to qigong but will not include the meditation or breathwork that will be included in the actual qigong intervention arm.

Group Type: SHAM_COMPARATOR

Sham Qigong

Intervention Type: BEHAVIORAL

This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.

Treatment-as-usual

This group will receive no classes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Qigong Intervention

Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.

Intervention Type: BEHAVIORAL

Sham Qigong

This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 50 year or older;
• HIV+,
• able to provide consent;
• must have reliable internet access; and
• willing to participate for the length of the intervention.

Exclusion Criteria

• Participants who are unable to stand for 10-minute segments (i.e., wheelchair or walker bound); and
• participants who have substantial (regular weekly practice for more than 3 months in the past 12 months) experience with mind-body interventions will be excluded because the control group may be contaminated by prior experience.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Borinquen Medical Centers of Miami Dade

Miami, Florida, United States

Countries

United States

References

Ibanez GE, Fennie K, Larkey L, Hu N, Algarin AB, Valdivia C, Lavretsky H. A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial. Trials. 2020 Sep 22;21(1):804. doi: 10.1186/s13063-020-04728-x.

Reference Type: DERIVED

PMID: 32962749 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R34AT009966-01

Identifier Type: NIH

Identifier Source: org_study_id

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