Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615000995572 |
Date of registration:
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22/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Cardiac Rehabilitation and the 'active couch potato' phenomenon.
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Scientific title:
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In cardiac patients attending a Phase II cardiac rehabilitation program does the ‘active couch potato’ phenomenon exist and what effect does it have on health outcomes? An international collaboration approach. |
Date of first enrolment:
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02/11/2015 |
Target sample size:
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75 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615000995572.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Nicole Freene
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Address:
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Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Australia |
Telephone:
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+61 2 6201 5550 |
Email:
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nicole.freene@canberra.edu.au |
Affiliation:
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Name:
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Dr Nicole Freene
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Address:
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Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Australia |
Telephone:
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+61 2 6201 5550 |
Email:
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nicole.freene@canberra.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Attending a phase II (outpatient) cardiac rehabilitation program, with stable coronary heart disease and receiving optimal medical treatment +/- revascularisation, that is, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty or another transcatheter procedure, or have had a myocardial infarction
Exclusion criteria: Participants will be excluded if they have New York Heart Association class II-IV symptoms of heart failure (or documented signs and symptoms of chronic heart failure, with ejection fraction < 45%), uncontrolled arrhythmias, severe chronic obstructive pulmonary disease, uncontrolled hypertension, symptomatic peripheral artery disease, unstable angina, uncontrolled diabetes, are unable to perform a submaximal walking test (6-minute walk test), or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Cardiovascular - Coronary heart disease
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coronary heart disease; coronary heart disease
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Intervention(s)
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Participants attending a phase II (outpatient) cardiac rehabilitation program will be included in this study. The outpatient cardiac rehabilitation program involves exercise and education sessions (1 hour each), twice a week, for 6 weeks. Participants physical activity levels and sedentary behaviour will be observed over 7-days at the start and end of the cardiac rehabilitation program, and at 6 and 12 months after admission into the cardiac rehabilitation program. One of the core components of cardiac rehabilitation is to increase participants exercise capacity and physical activity levels, aiming to achieve the public health physical activity guidelines (150 minutes of moderate-to-vigorous physical activity per week). There is some evidence in healthy adults that even if you achieve the physical activity guidelines, if you sit for too long, you are more likely to die from any cause (the active couch potato phenomenon). It is unknown if the active couch potato phenomenon exists in cardiac rehabilitation participants, and if it exists what effect this has on risk factors for heart disease.
This is an observational study and eligible cardiac rehabilitation participants’ will be encouraged to adhere to the cardiac rehabilitation program, with no additional encouragement to change their physical activity and/or sedentary behaviour provided over the 12-month data collection period.
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Primary Outcome(s)
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Sedentary behaviour (accelerometry, Past-Day Adults' Sedentary Time questionnaire)[Baseline, 6 weeks, 6 and 12 months]
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Physical activity (accelerometry, Active Australia Survey)[Baseline, 6 weeks, 6 and 12 months]
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Secondary Outcome(s)
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Low-density lipoprotein. Fasting blood samples will be taken from participants and will be analysed using the Abbott Architect Ci16200 system, according to the manufacturer’s guidelines. Low-density lipoprotein will be determined using the Friedewald formula [Baseline, 6 week, 6 & 12 months.]
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Total cholesterol. Fasting blood samples will be taken from participants and will be analysed using the Abbott Architect Ci16200 system, according to the manufacturer’s guidelines. [Baseline, 6 weeks, 6 and 12 months.]
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Anxiety. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of anxiety. [Baseline, 6 weeks, 6 and 12 months]
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Exercise Capacity.The 6-minute walk test (6MWT) is a commonly used objective measure of functional exercise capacity in cardiac rehabilitation. The distance an individual is able to walk along a flat 25-30 m walkway over a 6 minute period, with breaks as required, is recorded. The test is a self-paced, submaximal test of exercise capacity, and has been found to have a moderate-to-high reliability and validity. [Baseline, 6 weeks, 6 and 12 months]
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Waist-to-hip ratio (WHR).Waist circumference and hip circumferences will be measured in centimetres using a tape measure. [Baseline, 6 weeks, 6 and 12 months]
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Blood glucose level. Fasting blood samples will be taken from participants and will be analysed using the Abbott Architect Ci16200 system, according to the manufacturer’s guidelines. Each sample will be assessed for the glucose level. [Baseline, 6 weeks, 6 and 12 months]
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Body mass index (BMI). BMI (kg/m2) will be recorded using a calibrated set of scales and a stadiometer. [Baseline, 6 weeks, 6 and 12 months]
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Blood pressure. Blood pressure levels will be obtained using a mercury sphygmomanometer on the right arm of seated subjects. [Baseline, 6 weeks, 6 and 12 months]
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Blood triglycerides. Fasting blood samples will be taken from participants and will be analysed using the Abbott Architect Ci16200 system, according to the manufacturer’s guidelines. [Baseline, 6 weeks, 6 and 12 months]
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Health-related quality of life. The MacNew questionnaire will be used for the assessment of heart disease specific health-related quality of life. [Baseline, 6 weeks, 6 and 12 months]
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Depression. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of depression. [Baseline, 6 weeks, 6 & 12 months.]
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High-density lipoprotein- HDL. Fasting blood samples will be taken from participants and will be analysed using the Abbott Architect Ci16200 system, according to the manufacturer’s guidelines. [Baseline, 6 weeks, 6 & 12 months.]
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Secondary ID(s)
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Nil known.
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Source(s) of Monetary Support
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The Canberra Hospital
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University of Canberra
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Ethics review
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Status: Approved
Approval date:
Contact:
ACT Health Human Research Ethics Committee
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Results
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Results available:
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Yes |
Date Posted:
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23/11/2018 |
Date Completed:
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27/09/2017 |
URL:
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