Daoist Zhanzhuang and Human Flourishing
NCT Number: NCT06573034
Acronym: Z-Flo
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress, Physiological|Stress, Psychological|Inflammatory Response|Well-Being, Psychological
Interventions: BEHAVIORAL: Daoist Zhanzhuang|BEHAVIORAL: Sham Wall Squat
Sponsor: University of North Carolina, Charlotte
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2027-07
Locations: University of North Carolina at Charlotte, Charlotte, North Carolina, 28223, United States

Summary:
This project investigates the impact of Daoist Zhanzhuang (sometimes spelled as Chan Chuang) on human flourishing, and explores the physiological, psychological, and spiritual mechanisms. This study will be a two-arm randomized controlled trial, with mixed-methods and repeated-measures assessment of outcome variables. The two arms will include an active control condition (i.e., sham wall squat) and the Daoist Zhanzhuang condition. Outcome variables will include physiological measures of heart rate variability and inflammatory biomarkers, psychological scales of human flourishing variables, phenomenological interviews of mystical experiences, and daily ecological momentary assessment of human flourishing and mysticism. Randomly assigned into two conditions, 120 participants will complete a three-week intensive practice phase with 9 in-person sessions, followed by a nine-week self-guided practice phase with 4 in-person check-in sessions, and 3 follow-up practice and assessment sessions. Complete assessment (physiological measures, psychological scales, and phenomenological interviews) will be administered at five time points: T1 at about two weeks before the intervention, T2 at the end of the three-week intensive practice, T3 at the end of the 3-month intervention, T4 at the 6-month follow-up, and T5 at the 12-month follow-up. In addition, daily ecological momentary assessment of flourishing variables and practice-induced experiences will be administered daily after the practice for the entire 3-month intervention period.

Primary Outcome Measures: Increased heart rate variability, HRV will be collected using the H10 wear link and chest band (Polar Electro, Kempele, Finland) during several study activities, including 5 minutes of normal breathing at rest, a 5-minute paced-breathing task and during the 30-min intervention practice period. The normal and paced breathing assessments will occur at all data collection visits to estimate basal autonomic nervous system functioning., Day 1 in-person session, baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Decreased inflammatory biomarker CRP, Saliva will be collected via approved methods (IBC BIO-23-0032). Salivary inflammatory biomarkers will be assessed in-house at the Biobehavioral Core Lab. Salivary C-reactive protein (sCRP) will be quantified using commercially available enzyme immunoassays according to manufacturer instructions. CRP is a protein produced by the liver in response to the cell mediated biomarker cytokines., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Decreased perceived stress, The 4-item Perceived Stress Scale measured on visual analogue ranging from 0 to 100, higher scores suggesting worse outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Increased resilience, Brief Resilience Scale measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Decreased fatigue, The 10-item Fatigue Assessment Scale measured on visual analogue ranging from 0 to 100, higher scores suggesting worse outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Increased vitality, The 6-item Subjective Vitality Scale measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Increased mystical experiences, The brief 8-item Mysticism Scale measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Increased overall human flourishing, The 12-item Human Flourishing Measure measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).
Secondary Outcome Measures: Decreased inflammatory biomarker cytokine IL-1ß, Saliva will be collected via approved methods (IBC BIO-23-0032). Salivary inflammatory biomarkers will be assessed in-house at the Biobehavioral Core Lab. Plates will be read with a QuickPlex SQ 120 imager and data analyzed using the Discovery Workbench 4.0 for cytokines, including Interleukin (IL)-1ß., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Decreased inflammatory biomarker cytokine IL-6, Saliva will be collected via approved methods (IBC BIO-23-0032). Salivary inflammatory biomarkers will be assessed in-house at the Biobehavioral Core Lab. Plates will be read with a QuickPlex SQ 120 imager and data analyzed using the Discovery Workbench 4.0 for cytokines, including Interleukin (IL)-6., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Decreased inflammatory biomarker cytokine TNF-a, Saliva will be collected via approved methods (IBC BIO-23-0032). Salivary inflammatory biomarkers will be assessed in-house at the Biobehavioral Core Lab. Plates will be read with a QuickPlex SQ 120 imager and data analyzed using the Discovery Workbench 4.0 for cytokines, including TNF-a., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Increased interoceptive awareness, The subscales Noticing, Attention Regulation, Emotional Awareness, Self-Regulation, and Body Listening of Multidimensional Assessment of Interoceptive Awareness - 2 measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Reduced depression, Patient-Reported Outcomes Measurement Information System measured on visual analogue ranging from 0 to 100, higher scores suggesting worse outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).|Reduced anxiety, Patient-Reported Outcomes Measurement Information System measured on visual analogue ranging from 0 to 100, higher scores suggesting worse outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).
Other Outcome Measures: Psychological Insight, The 14-item subscale Avoidance and Maladaptive Patterns Insights of the Psychological Insight measured on visual analogue ranging from 0 to 100, higher scores suggesting better outcome., baseline T1 (before the intervention), the end of three-week intensive practice (T2), the end of the 3-month intervention (T3), the 6-month follow-up (T4), and the 12-month follow-up (T5).