Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00603

2 Trial Registration Date

2018-04-20

i Registration Status

Prospective

3 Secondary IDs

CREC Ref.No. 2017.353-T

4 Source(s) of Funding

Not applicable

5 Primary Sponsor

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ting Liu

ii Address

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region

iii Phone

(852) 3943 9909

iv Email

liuting@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong Special Administrative Region

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

i Name

Ting Liu

ii Address

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region

iii Phone

(852) 3943 9909

iv Email

liuting@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong Special Administrative Region

9 Official Scientific Title of the Study

Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease: A Randomized Controlled Trial

10 Public Title

Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease: A Randomized Controlled Trial

i Public Title in Chinese 研究名稱

基于小组和家庭练习的太极项目在改善冠心病患者身体机能、心理社会健康中的应用

11 Short Title (Optional)

A mixed Tai Chi program for CHD patients

12 Countries of Recruitment

Mainland China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-09-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.353-T

14 Medical Condition Being Studied

coronary heart disease

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Simplified 24-form Tai Chi

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

30-60min

v Duration of the intervention

12weeks

vi Frequency of the intervention

Tai Chi session 2/week for the first two-week, 3/week for the second two-week, and 4/week for the th

16 Comparative Treatments

i Description/ name of comparative treatments

usual care and non-exercise community activities

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

30-60min

iv Duration of the comparative treatments

6 weeks

v Frequency of the comparative treatments

1/week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) have been diagnosed with CHD

(2) age > 18 years old；

(3) be able to communicate in Chinese;

(4) do not participate in regular exercise (performed planned, structured physical activity at least 30 min at moderate intensity at least 3 d/week for at least 3 months)

ii Exclusion Criteria

(1) will have cardiac surgery planned during the following 6 months;

(2) presence of unstable angina, severe congestive heart failure or severe pulmonary disease;

(3) New York Heart Functional Classification Ⅳ；

(4) have been diagnosed with anxiety, depression or other mental illness; or have active treatment for mental illness;

(5) suffered from severe cognitive or sensory impairment (with the score of Abbreviated Mental Test lower than seven)

(6) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of TC;

iii Age Minimum

18

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized parallel control experiments

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

The study aims to conduct a group- plus home-based TC program for patients with CHDs, which will beneficial in improving physical and psychosocial well-being

20 Anticipated trial start date

2018-04-24

21 Target Sample Size

98

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Physical function (leg strength, leg flexibility, aerobic endurance, dynamic balance, and stationary balance)

ii The metric or method of measurement used

senior fitness tests：(a) two-minute step test to assess aerobic endurance; (b) chair stand test to evaluate leg strength; (c) chair sit-and-reach stand test to assess leg flexibility; (d) one-leg stand test to examine the stationary balance; (e) 8-foot-and-go test to assess the dynamic balance

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

24 Secondary Outcome

i The Name of the outcome

Perceived stress

ii The metric or method of measurement used

using Chinese Perceived Stress Scale

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

Secondary Outcome

i The Name of the outcome

Depression

ii The metric or method of measurement used

using the Centre for Epidemiological Studies of Depression

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

Secondary Outcome

i The Name of the outcome

Social support

ii The metric or method of measurement used

using Interpersonal Support Evaluation List

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

Secondary Outcome

i The Name of the outcome

Quality of Life

ii The metric or method of measurement used

using the 12-item Short Form Health Survey

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

Secondary Outcome

i The Name of the outcome

Exercise self-efficacy

ii The metric or method of measurement used

using the Chinese version of the self-efficacy for exercise and Tai Chi exercise self-efficacy

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

Secondary Outcome

i The Name of the outcome

Cardiovascular risk factors, inculding blood pressure (BP), blood lipid profile (total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein), blood sugar, body mass index (BMI) and body fat percentage (BF%)

ii The metric or method of measurement used

After an 8- to 10-h fasting, blood samples will be taken by using a finger-stick for the following measurements using autoanalyzers: blood lipid profiles and fasting blood sugar. BMI will be calculated as weight (kg) divided by the square of height (m). BF% could be calculated by a body fat monitor

iii The timepoint(s) of primary interest

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2), and 24 weeks for follow-up evaluation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-07-08

27 Primary Registry and Trial Identifying Number

ChiCTR1800016096

28 Date of Registration in Primary Registry

2018-04-20

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Trial History Detail on 2018-07-05