Early Phase 1
N=48
A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
Mental Health · Physical Health
Bottom Line
View on ClinicalTrials.gov: NCT03840525 ↗Enrolled (actual)
48
Serious AEs
4.2%
Results posted
Apr 2024
Primary outcome: Primary: Acceptability: Satisfaction With Weekly Intervention Sessions — 13; 12; 0; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- The Qigong Intervention (Behavioral); Sham Qigong (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability: Satisfaction With Weekly Intervention Sessions |
13; 12; 0; 12; 13; 0 | — |
| PRIMARY Acceptability: Are Participants Doing Home Practice Sessions at 2 Week Post Intervention |
8; 6; 0 | — |
| PRIMARY Acceptability: Session Attendance (Reported as Percentages) |
10; 9; 0 | — |
| PRIMARY Frequency of Home Practice Sessions at 2 Weeks Post Intervention (Week 14) |
6; 4 | — |
| PRIMARY Acceptability: Frequency of Home Practice Sessions at Week 24 (3 Months Post Intervention) |
7; 5; 0 | — |
| PRIMARY Acceptability: Home Practice of the Intervention at Week 24 (3 Months Post Intervention) |
10; 6; 0 | — |
| SECONDARY Change in Mental Health at 2 Weeks Post Intervention |
— | — |
| SECONDARY Change in Mental Health at 3 Months Post Intervention |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 2 Weeks Post Intervention |
— | — |
| SECONDARY Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 3 Months Post Intervention |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03840525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.