Effectiveness of mind-body meditation approach on improvement of mental and physical health of people with cardiovascular disease and risk factors

Effectiveness of mind-body meditation approach on improvement of mental and physical health of people with cardiovascular disease and risk factors: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87289137

Enrollment

2500

Registered

2013-08-09

Start date

2012-09-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary health care and secondary prevention Circulatory System

Interventions

Participants wil be randomized to: intervention (n=750) and control (n=750). Participants in all intervention and control groups will attend community centres in China and Gold Coast in Australia. Thi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: People who aged 35 and more, and with one of the following risk factors: obesity, metabolic syndrome, hypertension, abnormal cholesterol and fasting glucose.

Exclusion criteria

Exclusion criteria: People with severe neurological impairments, psychosis, severe cardiovascular disease including heart failure and stroke will be excluded.

Design outcomes

Primary

Measure	Time frame
Primary outcome measures will be recorded by the research coordinator. These measurements will be taken at three points: Baseline, 6 months after intervention, one year after intervention. 1. Current medication?s names and dose. 2. Blood pressure 3. Total serum cholesterol (TC), HDL-C and LDL-C levels 4. Height in cm/weight in kg/BMI/waist circumference in cm/waist hip ratio 5. Number of patients surviving during the study period 6. Number of hospital readmissions during the 12 months after entry to the program 7. Number of days spent in hospital during the 12 months after entry to the program	—

Measure

Time frame

Primary outcome measures will be recorded by the research coordinator. These measurements will be taken at three points: Baseline, 6 months after intervention, one year after intervention. 1. Current medication?s names and dose. 2. Blood pressure 3. Total serum cholesterol (TC), HDL-C and LDL-C levels 4. Height in cm/weight in kg/BMI/waist circumference in cm/waist hip ratio 5. Number of patients surviving during the study period 6. Number of hospital readmissions during the 12 months after entry to the program 7. Number of days spent in hospital during the 12 months after entry to the program

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Secondary

Measure	Time frame
Secondary outcome measures: The following measurements will be collected at baseline and at the final therapeutic singing and TC class, after 6 months of intervention, and follow up 3 months after interventions finish. 1. Exercise capacity as measured by the 6 minute walking test where patients walk at maximum effort and speed for 6 minutes. This test is of use with all ages, particularly older cardiac patients. It is reliable, especially in patients with heart failure. 2. Symptoms assessment: Minnesota Living with Heart Failure Questionnaire (LIhFE). The LihFE is a valid, reliable and responsive instrument of 21 items, and suitable for both asymptomatic and symptomatic CVD patients. 3. Quality of Life after Myocardial Infarction Questionnaire (QLMI), The QLMI contains subscales measuring physical symptoms and restrictions (the Limitations domain) and emotional function, confidence and self-esteem (the Emotions domain). It is reported to be a valid, reliable and responsive specific HRQL instrument. Developed in Canada, it has recently been modified and validated for use in Australia as the MacNew Quality of Life after MI Questionnaire. 4. EQ-5D: a 5-item health status questionnaire which provides health utility scores, widely used in health economic assessments of health interventions.	—

Measure

Time frame

Secondary outcome measures: The following measurements will be collected at baseline and at the final therapeutic singing and TC class, after 6 months of intervention, and follow up 3 months after interventions finish. 1. Exercise capacity as measured by the 6 minute walking test where patients walk at maximum effort and speed for 6 minutes. This test is of use with all ages, particularly older cardiac patients. It is reliable, especially in patients with heart failure. 2. Symptoms assessment: Minnesota Living with Heart Failure Questionnaire (LIhFE). The LihFE is a valid, reliable and responsive instrument of 21 items, and suitable for both asymptomatic and symptomatic CVD patients. 3. Quality of Life after Myocardial Infarction Questionnaire (QLMI), The QLMI contains subscales measuring physical symptoms and restrictions (the Limitations domain) and emotional function, confidence and self-esteem (the Emotions domain). It is reported to be a valid, reliable and responsive specific HRQL instrument. Developed in Canada, it has recently been modified and validated for use in Australia as the MacNew Quality of Life after MI Questionnaire. 4. EQ-5D: a 5-item health status questionnaire which provides health utility scores, widely used in health economic assessments of health interventions.

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026