Trial Outcomes & Findings for Improving Quality of Life for Adults Living With HIV and Chronic Pain (NCT NCT05055596)
NCT ID: NCT05055596
Last Updated: 2026-03-18
Results Overview
Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
Gentle Movement
Tai Chi: Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
|
Health Coaching
Health Coaching: The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Quality of Life for Adults Living With HIV and Chronic Pain
Baseline characteristics by cohort
| Measure |
Gentle Movement
n=18 Participants
Tai Chi: Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
|
Health Coaching
n=18 Participants
Health Coaching: The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 7.3 • n=110 Participants
|
61 years
STANDARD_DEVIATION 7.0 • n=114 Participants
|
61 years
STANDARD_DEVIATION 7 • n=224 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=110 Participants
|
12 Participants
n=114 Participants
|
24 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=110 Participants
|
11 Participants
n=114 Participants
|
26 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=110 Participants
|
18 participants
n=114 Participants
|
36 participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Pain Intensity - Brief Pain Inventory
Baseline (Week 0)
|
7.3 units on a scale
Standard Deviation 1.8
|
6.6 units on a scale
Standard Deviation 1.9
|
|
Pain Intensity - Brief Pain Inventory
Post-Intervention (Weeks 10-12)
|
6.1 units on a scale
Standard Deviation 2.2
|
6.1 units on a scale
Standard Deviation 2.2
|
|
Pain Intensity - Brief Pain Inventory
3-month Follow Up (Weeks 22-24)
|
5.6 units on a scale
Standard Deviation 2.9
|
7.4 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference.
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Pain Interference - Brief Pain Inventory
Baseline (Week 0)
|
5.9 score on a scale
Standard Deviation 1.5
|
5.8 score on a scale
Standard Deviation 2.3
|
|
Pain Interference - Brief Pain Inventory
Post-Intervention (Weeks 10-12)
|
4.7 score on a scale
Standard Deviation 3.3
|
5.8 score on a scale
Standard Deviation 2.0
|
|
Pain Interference - Brief Pain Inventory
3-month Follow Up (Weeks 22-24)
|
5.4 score on a scale
Standard Deviation 3.3
|
6.5 score on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)Population: % participants retained at follow-up
Ability to recruit and retain participants through intervention and follow-up assessments
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Feasibility to Execute Study Protocol
Post-Intervention (Weeks 10-12) · Retained at Follow Up
|
16 Participants
|
16 Participants
|
|
Feasibility to Execute Study Protocol
Post-Intervention (Weeks 10-12) · Missing Data
|
2 Participants
|
2 Participants
|
|
Feasibility to Execute Study Protocol
3-month Follow Up (Weeks 22-24) · Retained at Follow Up
|
16 Participants
|
16 Participants
|
|
Feasibility to Execute Study Protocol
3-month Follow Up (Weeks 22-24) · Missing Data
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Post-Intervention (Weeks 10-12)Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?"
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Very Satisfied
|
11 Participants
|
10 Participants
|
|
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Mostly Satisfied
|
3 Participants
|
4 Participants
|
|
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Indifferent
|
2 Participants
|
2 Participants
|
|
Participant Satisfaction Questionnaire (PSQ) - Acceptability
No Response
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)The Perceived Stress Scale is a measure of self-reported stress in the past month. There are 13 items and responses range from 0 (never) to 4 (very often). A total score is calculated and can range from 0 to 52, with higher scores indicated a greater degree of perceived stress.
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Perceived Stress Scale (PSS)
Baseline (Week 0)
|
25.7 score on a scale
Standard Deviation 4.5
|
28.1 score on a scale
Standard Deviation 5.2
|
|
Perceived Stress Scale (PSS)
Post-Intervention (Weeks 10-12)
|
26.0 score on a scale
Standard Deviation 5.0
|
26.6 score on a scale
Standard Deviation 4.8
|
|
Perceived Stress Scale (PSS)
3-month Follow Up (Weeks 22-24)
|
26.9 score on a scale
Standard Deviation 3.7
|
26.3 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations. The scale consists of 8 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated and possible scores range from 0 to 24, with higher scores indicated more depressive symptoms.
Outcome measures
| Measure |
Gentle Movement
n=18 Participants
Active intervention group
|
Health Coaching
n=18 Participants
Health coaching control group
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-8)
Baseline (Week 0)
|
10.8 score on a scale
Standard Deviation 7.0
|
12.4 score on a scale
Standard Deviation 5.2
|
|
Patient Health Questionnaire (PHQ-8)
Post-Intervention (Weeks 10-12)
|
9.4 score on a scale
Standard Deviation 7.8
|
10.3 score on a scale
Standard Deviation 7.1
|
|
Patient Health Questionnaire (PHQ-8)
3-month Follow Up (Weeks 22-24)
|
9.1 score on a scale
Standard Deviation 7.1
|
9.4 score on a scale
Standard Deviation 6.0
|
Adverse Events
Gentle Movement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place