NCT03562078

Brief Summary

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

May 22, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

April 18, 2018

Last Update Submit

June 18, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Tai Chi QuanHbA1cquality of life

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    HbA1c

    change from Baseline to 12 weeks

Secondary Outcomes (11)

  • fasting blood glucose

    change from Baseline to 12 weeks

  • triglycerides

    change from Baseline to 12 weeks

  • high and low density lipoprotein

    change from Baseline to 12 weeks

  • creatinine

    change from Baseline to 12 weeks

  • estimated Glomerular Filtration Rate (eGFR)

    change from Baseline to 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Tai Chi Quan for Type 2 Diabetes

EXPERIMENTAL

diabetic patients care education and Tai Chi Quan training, including 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training, twice a week for 12 weeks.

Behavioral: Tai Chi Quan

Control Group for Type 2 Diabetes

NO INTERVENTION

diabetic patients care education

Interventions

Tai Chi QuanBEHAVIORAL

the first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week

Tai Chi Quan for Type 2 Diabetes

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~80 years old
  • Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.
  • Consciousness clear and is voluntary to attend the project and with the agreement.
  • The functional movement ability is independent

You may not qualify if:

  • Pregnant or plan to be pregnant in six months, and breast feeding.
  • Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.
  • Evaluated that the compliance for the intervention is not appropriate.
  • The blood glucose \> 300mg/dl and unable to do vigorous exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital

Taipei, 104, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Chien-Jung Huang, Bachelor

    Taipei City Hospital

    STUDY CHAIR

Central Study Contacts

Chien-Jung Huang, Bachelor

CONTACT

(+886)2-2591-6681DAI62@tpech.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

June 19, 2018

Study Start

May 22, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

TW(1)