Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00449

2 Trial Registration Date

2015-03-20

i Registration Status

Prospective

3 Secondary IDs

2014.131-T

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Health and Medical Research Fund

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Aileen Chan

ii Address

7/F., Esther Lee Building, the Nthersole School of Nursing, CUHK

iii Phone

39434290

iv Email

aileenchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Aileen Chan

ii Address

7/F., Esther Lee Building, the Nthersole School of Nursing, CUHK

iii Phone

39434290

iv Email

aileenchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Evaluation of the effectiveness of tai chi versus brisk walking in reducing cardiovascular risk factors: A randomized controlled trial

10 Public Title

Evaluation of the effectiveness of tai chi versus brisk walking in reducing cardiovascular risk factors

i Public Title in Chinese 研究名稱

評估太極及步行運動對減少心血管風險因素的效果

11 Short Title (Optional)

Tai chi reduces cardiovascular risk factors

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-03-13

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2014.131-T

14 Medical Condition Being Studied

people with cardiovascular risk factors

15 Intervention

i Types of intervention

Other

Please specify

Exercise

ii Description/ name of Intervention/article

Yang Style 24 forms tai chi

iii Dosage form of the intervention

Tai chi training

iv Dosage of the intervention

60-minute sessions, twice a week

v Duration of the intervention

Three months

vi Frequency of the intervention

Twice a week for 3 months, self practice for 30 minutes daily

16 Comparative Treatments

i Description/ name of comparative treatments

The walking group will perform brisk walking for 30 minutes every day. The control group will receive their usual care.

ii Dosage form of the comparative treatments

Brisk walking

iii Dosage of the comparative treatments

30 minutes daily

iv Duration of the comparative treatments

3 months

v Frequency of the comparative treatments

30 minutes daily

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Subjects meet at least three but not more than four of the following CVD risk factors that are defined according to the American Heart Association:(3)
1. Males older than 45 years
2. Females older than 55 years or postmenopausal
3. Smoker
4. Systolic blood pressure (SBP) >140 or diastolic blood pressure (DBP) >90 or taking blood pressure medication
5. Fasting cholesterol level > 6.2 mmol/l
6. Have diabetes or taking medicine to control blood sugar
7. Physically inactive (get <30 minutes of physical activity for at least 3 days a week)
8. BMI >25 kg/m2or waist circumference > 90 cm (men) or >80 cm (women)

ii Exclusion Criteria

1. Have developed cardiovascular disease
2. Suffered from severe sensory or cognitive impairment
3. Cannot walk independently
4. Have musculoskeletal disorders or other disabling diseases that may limit the practice of tai chi
5. Have previous training and practicing tai chi within a year prior to the commencement of the study

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Coumpter generated random numbers

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-07-01

21 Target Sample Size

246

22 Recruitment Status

Recruiting

23 Primary Outcome

Blood pressure at baseline, 3 months, 6 months and 9 months

24 Secondary Outcome

body mass index, waist circumference, body fat percentage, fasting blood for cholesterol, triglyceride, and sugar;
Perceived stress level measured by PSS-10, and quality of life measured by SF12v2

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-07-18

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006129

28 Date of Registration in Primary Registry

2015-03-22

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Trial History Detail on 2016-04-21