Clinical trial NCT03840525: A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
Official title: A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mental Health
Physical Health
Keywords: qigong
HIV
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2019-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will implement a 3 arm study including the qigong intervention, sham qigong intervention, and a treatment as usual condition. The qigong and sham qigong groups will be delivered virtually due to the coronavirus pandemic.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Acceptability: Satisfaction With Weekly Intervention Sessions
timeFrame: Assessments were conducted at Week 1 to Week 12 (i.e., once a week for 12 weeks). All weekly scores were averaged across weeks. The number of participants with an average score of 4.00 or higher found the intervention acceptable and is reported below
measure: Acceptability: Are Participants Doing Home Practice Sessions at 2 Week Post Intervention
timeFrame: Assessment was conducted 2 week post intervention (Week 14)
measure: Acceptability: Session Attendance (Reported as Percentages)
timeFrame: Assessments were conducted at Week 1 up to Week 12 (i.e., once a week after each session).
measure: Frequency of Home Practice Sessions at 2 Weeks Post Intervention (Week 14)
timeFrame: Assessments were conducted once at 2 week post intervention (Week 14).
measure: Acceptability: Frequency of Home Practice Sessions at Week 24 (3 Months Post Intervention)
timeFrame: Outcome was measured at Week 24 (i.e., 3 month post intervention)
measure: Acceptability: Home Practice of the Intervention at Week 24 (3 Months Post Intervention)
timeFrame: Outcome was measured at Week 24 (3 month post intervention).
Secondary outcomes:
measure: Change in Mental Health at 2 Weeks Post Intervention
timeFrame: Assessments will be conducted at baseline, 2 weeks post intervention
measure: Change in Mental Health at 3 Months Post Intervention
timeFrame: Assessments will be conducted at baseline, 3 months post intervention
measure: Change in Physical Health Status as Measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 Items) at 2 Weeks Post Intervention
timeFrame: Assessments will be conducted at baseline, 2 weeks post intervention
measure: Change in Physical Health Status as Measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 Items) at 3 Months Post Intervention
timeFrame: Assessments will be conducted at baseline, 3 months post intervention
measure: Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 2 Weeks Post Intervention
timeFrame: Assessments will be conducted at baseline, 2 weeks post intervention
measure: Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 3 Months Post Intervention
timeFrame: Assessments will be conducted at baseline, 3 months post intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: Borinquen Medical Centers of Miami Dade
state: Florida
Study officials:
References:
citation: 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.