Trial Outcomes & Findings for A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV (NCT NCT03840525)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

48 participants

Primary outcome 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

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	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. The Qigong Intervention: 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. Sham Qigong: 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.
Overall Study STARTED	16	16	16
Overall Study COMPLETED	13	12	10
Overall Study NOT COMPLETED	3	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The baseline data for 1 participant (assigned to the sham control group) was lost by accident.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Qigong Intervention n=16 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=16 Participants 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. Sham Qigong: This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.	Treatment-as-usual n=16 Participants This group will receive no classes.	Total n=48 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 6.0 • n=16 Participants	61.0 years STANDARD_DEVIATION 6.0 • n=16 Participants	61.0 years STANDARD_DEVIATION 4.0 • n=16 Participants	60.0 years STANDARD_DEVIATION 5.0 • n=48 Participants
Sex/Gender, Customized Gender · Male	8 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	9 Participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	9 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	26 Participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.
Sex/Gender, Customized Gender · Female	6 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	6 Participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	7 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	19 Participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.
Sex/Gender, Customized Gender · Transgender/Other	2 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	0 Participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	0 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	2 Participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.
Race/Ethnicity, Customized Race · White	9 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	7 Participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	8 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	24 Participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.
Race/Ethnicity, Customized Race · Black	7 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	8 Participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	8 Participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	23 Participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.
Region of Enrollment United States	16 participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	15 participants n=15 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	16 participants n=16 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.	47 participants n=47 Participants • The baseline data for 1 participant (assigned to the sham control group) was lost by accident.

PRIMARY outcome

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

Population: The treatment as usual group is 0 because they did not receive any classes. Only the qigong intervention and the sham qigong groups were asked these items because they are the only ones receiving classes.

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.

Outcome measures

Outcome measures
Measure	Qigong Intervention n=13 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=13 Participants 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. Sham Qigong: 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.
Acceptability: Satisfaction With Weekly Intervention Sessions Acceptability: Enjoyed classes	13 Participants	12 Participants	0 Participants
Acceptability: Satisfaction With Weekly Intervention Sessions Acceptability: Class met expectations	12 Participants	13 Participants	0 Participants
Acceptability: Satisfaction With Weekly Intervention Sessions Acceptability: Instructor engaged	13 Participants	12 Participants	0 Participants

PRIMARY outcome

Timeframe: Assessment was conducted 2 week post intervention (Week 14)

Population: The treatment as usual group is 0 because they did not receive any classes to practice. The sample size for the qigong and the sham qigong groups reflect the number of participants that completed the 2 week post intervention assessments.

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.

Outcome measures

Outcome measures
Measure	Qigong Intervention n=11 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=9 Participants 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. Sham Qigong: 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.
Acceptability: Are Participants Doing Home Practice Sessions at 2 Week Post Intervention	8 Participants	6 Participants	0 Participants

PRIMARY outcome

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

Population: The treatment as usual group was not analyzed since they did not receive any classes and therefore had no attendance.

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.

Outcome measures

Outcome measures
Measure	Qigong Intervention n=16 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=16 Participants 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. Sham Qigong: 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.
Acceptability: Session Attendance (Reported as Percentages)	10 Participants	9 Participants	0 Participants

PRIMARY outcome

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

Population: Analysis population is based on participants who completed the 2 week follow up assessment and who reported practicing the movements.

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.

Outcome measures

Outcome measures
Measure	Qigong Intervention n=8 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=6 Participants 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. Sham Qigong: 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.
Frequency of Home Practice Sessions at 2 Weeks Post Intervention (Week 14)	6 Participants	4 Participants	—

PRIMARY outcome

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

Population: Participants in the Treatment as usual group was not analyzed because they did not receive any group sessions or instructions so there were no movements to practice at home.

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 measures

Outcome measures
Measure	Qigong Intervention n=10 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=6 Participants 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. Sham Qigong: 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.
Acceptability: Frequency of Home Practice Sessions at Week 24 (3 Months Post Intervention)	7 Participants	5 Participants	0 Participants

PRIMARY outcome

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

Population: The treatment as usual control group did not receive any group sessions so there was no home practice to report.

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 measures

Outcome measures
Measure	Qigong Intervention n=13 Participants 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=13 Participants 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. Sham Qigong: 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.
Acceptability: Home Practice of the Intervention at Week 24 (3 Months Post Intervention)	10 Participants	6 Participants	0 Participants

Adverse Events

Qigong Intervention

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Qigong

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment-as-usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Qigong Intervention n=16 participants at risk 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=16 participants at risk 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. Sham Qigong: This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.	Treatment-as-usual n=16 participants at risk This group will receive no classes.
Infections and infestations Hospitalization	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.
Surgical and medical procedures Kidney biopsy	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.

Other adverse events

Other adverse events
Measure	Qigong Intervention n=16 participants at risk 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. The Qigong Intervention: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.	Sham Qigong n=16 participants at risk 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. Sham Qigong: This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.	Treatment-as-usual n=16 participants at risk This group will receive no classes.
Musculoskeletal and connective tissue disorders Participant experience soreness due to intervention	6.2% 1/16 • Number of events 2 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.	0.00% 0/16 • Adverse events were collected throughout the duration of the clinical trials: from enrollment (baseline interview) through the intervention phase (3 months), and until study completion (3 month post intervention). Therefore, adverse event data were collected for 6 months.

Additional Information

Dr. Gladys Ibanez

Florida International University

Phone: 305-348-4920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place