NCT03640169

Brief Summary

The purpose of this project is to design a health management model of TCM preventive medicine that meets the need of healthy or suboptimal healthy people. This project will try to practice "Health management model of TCM preventive medicine" together with health promotion groups related to Taiwan Society of Health Promotion in the district of Shilin and Zhongzheng in Taipei city, and plan to recruit 100 people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

July 20, 2018

Last Update Submit

August 23, 2018

Conditions

Preventive MedicineHealth Promotion

Keywords

Health Management ModelChinese MedicinePreventive MedicineBody ConstitutionHealth Promotion

Outcome Measures

Primary Outcomes (9)

  • Body Constitution Scores (measured by Body Constitution Questionnaire, BCQ)

    The measurement of Body Constitution Questionnaire will come out 3 scores: Scores of Yang-deficiency: ranged from 19-95 Score of Yin- deficiency: ranged from 19-95 Score of Stasis: ranged from 16-80 The higher the score, the worse the Yang- deficiency, Yin- deficiency and Stasis.

    Change from Baseline Body Constitution Yang- deficiency, Yin- deficiency and Stasis Scores at 8 week

  • Blood pressure

    Change of both systolic and diastolic pressure after 8 week

    Change from baseline of both systolic and diastolic pressure at 8 week

  • Heart rate

    Change of Heart rate after 8 week

    Change from Baseline Heart rate at 8 week

  • Heart rate variability

    Change of Heart rate variability after 8 week

    Change from Baseline Heart rate variability at 8 week

  • Blood oxygen concentration

    Change of Blood oxygen concentration after 8 week

    Change from Baseline Blood oxygen concentration at 8 week

  • Pittsburgh Sleep Quality Index

    Change of the global score of Pittsburgh Sleep Quality Index after 8 week The higher the global score, the worse the sleep quality. If the global \<=5, defined to have good sleep quality; If the global \> 5, defined to have bad sleep quality.

    Change from Baseline total score of Pittsburgh Sleep Quality Index at 8 week

  • Brief Symptom Rating Scale（BSRS-5）

    Change of the score of the Brief Symptom Rating Scale after 8 week. Score ranged from 0-24: the higher the score the worse the physical and mental condition.

    Change from Baseline BSRS-5 at 8 week

  • Dietary behavior Instrument

    Change of score of the Dietary behavior Instrument after 8 week. Score ranged from 0-36: the higher the score, the better the eating behavior.

    Change from Baseline total score of the Dietary behavior Instrument at 8 week

  • Pressure index

    Change of the pressure feeling after 8 week. Score ranged from 0-12: the higher the score, the heavy the pressure feeling.

    Change from Baseline score of Pressure index at 8 week

Study Arms (1)

Management of TCM preventive medicine

EXPERIMENTAL

The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Duo-in qigong practice.

Other: Health management of TCM preventive medicine

Interventions

Health management of TCM preventive medicineOTHER

The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Duo-in qigong practice.

Management of TCM preventive medicine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 20 y/o.
  • can walk independently, without disability
  • can communicate with Chinese or Taiwanese, and understand the purpose of the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan Society of Health Promotion

Taipei, 106, Taiwan

Location

Related Publications (1)

  • Tsai YN, Chang YH, Su YC, Lee SM, Hsiao CH, Lin CK, Lin SJ. A community-based Daoyin program for health promotion: effects of the Qi and mind harmonizing method on body constitution for the health of older adults. Front Public Health. 2026 Jan 5;13:1644273. doi: 10.3389/fpubh.2025.1644273. eCollection 2025.

    PMID: 41561842DERIVED

Study Officials

  • Yi-Chang Su, PhD

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 21, 2018

Study Start

July 7, 2017

Primary Completion

September 16, 2017

Study Completion

September 16, 2017

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

TW(1)