Mental HealthEarly Phase 1NCT03840525
A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
A Early Phase 1 study testing The Qigong Intervention in people with Mental Health and Physical Health, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mental Health, Physical Health
- What is being tested?
- The Qigong Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 30 Sep 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 year or older;
- HIV+,
- able to provide consent;
- must have reliable internet access; and
- willing to participate for the length of the intervention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Borinquen Medical Centers of Miami Dade
Miami, Florida, 33137
About this study
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.
Read the 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
- Being tested
- The Qigong Intervention, Sham Qigong
- Keywords
- qigong, HIV
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Qigong InterventionBehavioural
Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.
Sham QigongBehavioural
This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Qigong |
| Treatment-as-usual | No intervention | This group will receive no classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Outcome was measured at Week 24 (3 month post intervention).
Secondary outcomes (6)
Change in Mental Health at 2 Weeks Post Intervention
Mental Health will be assessed using the following standardized scale: the Depression Anxiety \& Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms
Measured: Assessments will be conducted at baseline, 2 weeks post intervention
Change in Mental Health at 3 Months Post Intervention
Mental Health will be assessed using the following standardized scale: the Depression Anxiety \& Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms
Measured: 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
Physical Health will be assessed using the following standardized scale: The Revised Sign \& Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.
Measured: 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
Physical Health will be assessed using the following standardized scale: The Revised Sign \& Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.
Measured: 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
Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.
Measured: Assessments will be conducted at baseline, 2 weeks post intervention
Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 3 Months Post Intervention
Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.
Measured: Assessments will be conducted at baseline, 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start6 Jan 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840525
- Sponsor's protocol ID
- 1R34AT009966-01
- Status last verified
- Mar 2024
- First submitted
- 16 Jul 2018
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32962749
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
- ClinicalTrials.gov ID
- NCT03840525
- Acronym / sponsor ID
- 1R34AT009966-01
- Conditions
- Mental Health, Physical Health
- Keywords
- qigong, HIV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Qigong Intervention | Experimental | Behavioral: The Qigong InterventionThe 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. |
| Sham Qigong | Sham comparator | Behavioral: Sham QigongThis 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. |
| Treatment-as-usual | No intervention | –This group will receive no classes. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 year or older;
- HIV+,
- able to provide consent;
- must have reliable internet access; and
- willing to participate for the length of the intervention.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Qigong InterventionQigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors. | Behavioural | Qigong Intervention |
| Sham QigongThis intervention includes similar body movements to qigong; however, it does not have the meditative or breath work. | Behavioural | Sham Qigong |
Primary outcome
Acceptability: Satisfaction With Weekly Intervention Sessions
Time frame: 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
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.
Acceptability: Are Participants Doing Home Practice Sessions at 2 Week Post Intervention
Time frame: Assessment was conducted 2 week post intervention (Week 14)
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.
Acceptability: Session Attendance (Reported as Percentages)
Time frame: Assessments were conducted at Week 1 up to Week 12 (i.e., once a week after each session).
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.
Frequency of Home Practice Sessions at 2 Weeks Post Intervention (Week 14)
Time frame: Assessments were conducted once at 2 week 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.
Acceptability: Frequency of Home Practice Sessions at Week 24 (3 Months Post Intervention)
Time frame: Outcome was measured at Week 24 (i.e., 3 month 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.
Acceptability: Home Practice of the Intervention at Week 24 (3 Months Post Intervention)
Time frame: Outcome was measured at Week 24 (3 month 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.
6 secondary outcomes
Change in Mental Health at 2 Weeks Post Intervention
Time frame: Assessments will be conducted at baseline, 2 weeks post intervention
Change in Mental Health at 3 Months Post Intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessments will be conducted at baseline, 2 weeks post intervention
Change in Physical Health Status as Measured by The HIV-related Fatigue Scale (Belza, et al.,16 Items) at 3 Months Post Intervention
Time frame: Assessments will be conducted at baseline, 3 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32962749Ibanez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing The Qigong Intervention in people with Mental Health and Physical Health, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: Satisfaction With Weekly Intervention Sessions (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03840525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.