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

NCT03840525 | Completed Early Phase 1 Results DMC

• 1 other identifier: 1R34AT009966-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Physical Health

Keywords

qigong; HIV

Outcome Measures

Primary Outcomes (6)

• Acceptability: Satisfaction With Weekly Intervention Sessions

  Satisfaction were measured by asking the following questions after each session: "I really enjoyed today's class"; "Today's class met my expectations"; "The instructor was engaged in today's class". Responses are on a 5 point Likert scale (1=strongly disagree to 5=strongly agree) with lower scores meaning less satisfaction. Both the qigong intervention and the sham qigong control group will be asked these satisfaction items. Acceptability was defined as responding either agree (4) or strongly agree (5) to each of these items. Therefore, participants who had an average score of at least 4.00 across all 12 weekly groups was considered a participant that found the intervention acceptable. The number of participants who found the intervention is counted below.

  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

• Acceptability: Are Participants Doing Home Practice Sessions at 2 Week Post Intervention

  Acceptability was measured by asking the following question at 2 weeks post intervention (Week 14): Did you practice at home this week? Response format is yes=1, no=0 . This outcome determines if the participants continued their home practice of Qigong 2 weeks after the end of the intervention. The number of participants who responded yes were summed and reported below. The intervention was deemed acceptable to participants if at least 80% of participants were still practicing at home at Week 14.

  Assessment was conducted 2 week post intervention (Week 14)

• Acceptability: Session Attendance (Reported as Percentages)

  The investigators collected attendance after each weekly session (Week 1 to Week 12). An average attendance across all weekly sessions was calculated by taking the number of groups attended divided by the number of total sessions possible. The intervention was deemed acceptable if participants attended at least 70% of the weekly groups. The number of participants who attended 70% of the weekly groups were summed and reported below.

  Assessments were conducted at Week 1 up to Week 12 (i.e., once a week after each session).

• Frequency of Home Practice Sessions at 2 Weeks Post Intervention (Week 14)

  The investigators collected information on how often participants practiced at home at two weeks post intervention (Week 14). At Week 14, participants were asked 'If you are practicing at home, how often did you practice the movements?' Response format is: 1=very frequent (every day), 2=frequent (a few times a week), 3=infrequent (once a week), and 4=very infrequent (less than once a week). Scores were averaged with the acceptability benchmark being that participants who practiced very frequently (1) or frequently (2) found the intervention acceptable. That is, participants whose average score was 2.00 or less considered the intervention acceptable. The number of participants who found the intervention acceptable were summed and reported below.

  Assessments were conducted once at 2 week post intervention (Week 14).

• Acceptability: Frequency of Home Practice Sessions at Week 24 (3 Months Post Intervention)

  The investigators collected information on how frequently the participants were practicing the intervention at home at Week 24. Participants were asked the following: "If practicing at home in the last 3 months, how often have you practiced the movements?" Responses were 1=very frequently (every day), 2= frequently (a few times a week), 3=infrequently (once a week), or 4=very infrequently (less than once a week). Acceptability was determined if at least 70% of the participants reported very frequently (1) or frequently (2) home practice at Week 24. Participants with scores of 2.00 or less on this item were summed and then divided by the number of participants who reported any home practice in the last 3 months and also completed an assessment at Week 24.

  Outcome was measured at Week 24 (i.e., 3 month post intervention)

• Acceptability: Home Practice of the Intervention at Week 24 (3 Months Post Intervention)

  The investigators collected information on home practice sessions at Week 24 (the 3 month follow up assessment. Participants were asked the following: "have you practiced any of the movements in the last 3 months?" Response format was No=0, Yes=1. The acceptability benchmark was set at 70%. If at least 70% of participants reported any home practice at 3 months (Week 24) post intervention, the intervention would be deemed acceptable. The number of participants were summed and then divided by the number of participants assigned to the participant's study group assignment and who completed an assessment at week 24 in order to calculate a percentage.

  Outcome was measured at Week 24 (3 month post intervention).

Secondary Outcomes (6)

• Change in Mental Health at 2 Weeks Post Intervention

  Assessments will be conducted at baseline, 2 weeks post intervention

• Change in Mental Health at 3 Months Post Intervention

  Assessments will be conducted at baseline, 3 months post intervention

• 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

  Assessments will be conducted at baseline, 2 weeks post intervention

• 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

  Assessments will be conducted at baseline, 3 months post intervention

• Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 2 Weeks Post Intervention

  Assessments will be conducted at baseline, 2 weeks post intervention

Study Arms (3)

Qigong Intervention

EXPERIMENTAL

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.

Behavioral: The Qigong Intervention

Sham Qigong

SHAM COMPARATOR

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.

Behavioral: Sham Qigong

Treatment-as-usual

NO INTERVENTION

This group will receive no classes.

Interventions

The Qigong Intervention BEHAVIORAL

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

Qigong Intervention

Sham Qigong BEHAVIORAL

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

Sham Qigong

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead
• Arizona State University: collaborator

Study Sites (1)

Borinquen Medical Centers of Miami Dade

Miami, Florida, 33137, United States

Location

Related Publications (1)

• 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.

  PMID: 32962749 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

Sample size was reduced, with NIH approval, due to the Covid-19 pandemic.

Results Point of Contact

• Title: Dr. Gladys Ibanez
• Organization: Florida International University

gibanez@fiu.edu

305-348-4920

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There will be a sham qigong arm of the study to mask qigong participation for the participants
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: February 15, 2019
• Study Start: January 6, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Locations

US (1)