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Trial Detail

CUHK_CCRB00572

2017-12-14

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 Pilot 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 Pilot 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 coronary heart disease

Mainland China

Yes

2017-09-29

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref. No. 2017.353-T

coronary heart disease

Behavior

Simplified 24-form Tai Chi

N/A

60 min/session

12 weeks

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

30-60 min

6 weeks

1/week

have been diagnosed with CHD

age > 18 years old

be able to communicate in Chinese

(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) suffered from severe cognitive or sensory impairment (Abbreviated Mental Test score < 7)

(4) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of Tai Chi;

(5) have previous training and practiced TC, or participated in other formal physical activity, within six months prior to the commencement of study.

18

90

Both Male and Female

Interventional

Randomized

Randomized parallel control experiments

Placebo

Single-blind

Trial subjects

Parallel

1

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

2017-12-20

20

Complete

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)

Feasibility

including drop-out rate, attendance at class and individual home-based TC practice

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Perceived stress

using Chinese Perceived Stress Scale

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Depression

using the Centre for Epidemiological Studies of Depression

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Social support

using Interpersonal Support Evaluation List

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

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)

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)

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)

No

2018-12-20

ChiCTR-IIC-17013986

2017-12-14

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