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Trial History Detail on 2018-07-05

CUHK_CCRB00603

2018-04-20

Prospective

CREC Ref.No. 2017.353-T

Not applicable

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

N/A

Not Applicable

Ting Liu

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

(852) 3943 9909

liuting@link.cuhk.edu.hk

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

Hong Kong Special Administrative Region

Ting Liu

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

(852) 3943 9909

liuting@link.cuhk.edu.hk

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

Hong Kong Special Administrative Region

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

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

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

A mixed Tai Chi program for CHD patients

Mainland China

Yes

2017-09-29

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.353-T

coronary heart disease

Behavior

Simplified 24-form Tai Chi

N/A

30-60min

12weeks

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

usual care and non-exercise community activities

N/A

30-60min

6 weeks

1/week

(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)

(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;

18

90

Both Male and Female

Interventional

Randomized

Randomized parallel control experiments

Placebo

Single-blind

Investigator/research team

Parallel

2

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

2018-04-24

98

Not Yet Recruiting

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

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

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

Perceived stress

using Chinese Perceived Stress Scale

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

Depression

using the Centre for Epidemiological Studies of Depression

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

Social support

using Interpersonal Support Evaluation List

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

Quality of Life

using the 12-item Short Form Health Survey

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

Exercise self-efficacy

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

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

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%)

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

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

No

2019-07-08

ChiCTR1800016096

2018-04-20

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