Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000995572
Ethics application status
Approved
Date submitted
3/09/2015
Date registered
22/09/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiac Rehabilitation and the 'active couch potato' phenomenon.
Scientific title
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.
Secondary ID [1] 286541 0
Nil known.
Universal Trial Number (UTN)
U1111-1169-3409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 294778 0
Condition category
Condition code
Cardiovascular 295061 295061 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 292765 0
Not applicable
Comparator / control treatment
Nil. Observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296027 0
Physical activity (accelerometry, Active Australia Survey)
Timepoint [1] 296027 0
Baseline, 6 weeks, 6 and 12 months
Primary outcome [2] 296058 0
Sedentary behaviour (accelerometry, Past-Day Adults' Sedentary Time questionnaire)
Timepoint [2] 296058 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [1] 317276 0
Body mass index (BMI). BMI (kg/m2) will be recorded using a calibrated set of scales and a stadiometer.
Timepoint [1] 317276 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [2] 317391 0
Waist-to-hip ratio (WHR).Waist circumference and hip circumferences will be measured in centimetres using a tape measure.
Timepoint [2] 317391 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [3] 317392 0
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.
Timepoint [3] 317392 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [4] 317393 0
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.
Timepoint [4] 317393 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [5] 317394 0
Blood pressure. Blood pressure levels will be obtained using a mercury sphygmomanometer on the right arm of seated subjects.
Timepoint [5] 317394 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [6] 317395 0
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.
Timepoint [6] 317395 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [7] 317396 0
Health-related quality of life. The MacNew questionnaire will be used for the assessment of heart disease specific health-related quality of life.
Timepoint [7] 317396 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [8] 317397 0
Anxiety. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of anxiety.
Timepoint [8] 317397 0
Baseline, 6 weeks, 6 and 12 months
Secondary outcome [9] 317578 0
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.
Timepoint [9] 317578 0
Baseline, 6 weeks, 6 and 12 months.
Secondary outcome [10] 317579 0
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.
Timepoint [10] 317579 0
Baseline, 6 weeks, 6 & 12 months.
Secondary outcome [11] 317580 0
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
Timepoint [11] 317580 0
Baseline, 6 week, 6 & 12 months.
Secondary outcome [12] 317581 0
Depression. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of depression.
Timepoint [12] 317581 0
Baseline, 6 weeks, 6 & 12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number of minutes per day spent in sedentary behaviour will be calculated using standard count-based intensity threshold values of counts per minute: < 100 for sedentary behaviour (<1.5 MET). Four further summary measures of sedentary behaviours will calculated per day and averaged over valid days: (a) percentage of the wear-day spent in sedentary behaviour (b) number of sedentary bouts (defined as a period of consecutive minutes where the accelerometer registered <100 counts/minutes) (c) average duration of sedentary bouts and (d) number of sedentary breaks (defined as at least 1 min where the accelerometer registered >= 100 counts/minute following a sedentary bout). The Freedson Combination energy expenditure algorithm will be used to determine the intensity cut-points for MVPA. This outcome variable will be used to investigate whether participants have reached the World Health Organisation physical activity guidelines.
Linear regression models will be performed at each data collection point, where the dependent variables will be each of the health variables available. The models will have the different summary measures of sedentary behaviour (i.e. one model will be performed with each one) as main independent variables, and models will also be performed for MVPA and each of the different physical activity intensities (i.e. light, moderate and vigorous physical activity). If it is the case, quadratic trends might be explored. The models will be adjusted for total time of activity (i.e. counts per min >= 100), gender, socioeconomics variables, BMI and other potential confounders available.
Additional analyses will be completed with a one-way repeated measures analysis of variance (ANOVA) to test for differences in physical activity and sedentary behaviour (with a 95% confidence interval (CI)) within the Australian sample over 12 months. Intention-to-treat analysis will be used at 6-weeks, 6 and 12-months where data is missing, bringing the last value forward. A maximum of three attempts will be made to contact participants so outcome measures can be obtained, making the analysis more complete.

Sample size
The G*Power software v.3.1.9.2 was used to a priori determine the required sample size. Previous recommendations for sample size estimation in Multiple Linear Regression problems were used. With a desired effect size of f2 = 0.5 (large), given a maximum of 10 predictor variables including potential confounders, a sample size of n= 59 is needed to achieve a power of 0.95 in a test based on a = 0.05. Assuming a dropout rate of 25%, 75 participants will be recruited for the Australian study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2015
Actual
2/11/2015
Date of last participant enrolment
Anticipated
15/02/2016
Actual
31/08/2016
Date of last data collection
Anticipated
Actual
27/09/2017
Sample size
Target
75
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 4302 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 10238 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 291981 0
University
Name [1] 291981 0
University of Canberra
Country [1] 291981 0
Australia
Funding source category [2] 291982 0
Hospital
Name [2] 291982 0
The Canberra Hospital
Country [2] 291982 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Freene
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 290644 0
Individual
Name [1] 290644 0
Dr Borja del Pozo Cruz
Address [1] 290644 0
University of Auckland, Victoria Street West, Auckland 1142
Country [1] 290644 0
New Zealand
Secondary sponsor category [2] 290646 0
Individual
Name [2] 290646 0
Prof Rachel Davey
Address [2] 290646 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [2] 290646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293473 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 293473 0
Ethics committee country [1] 293473 0
Australia
Date submitted for ethics approval [1] 293473 0
29/04/2015
Approval date [1] 293473 0
31/08/2015
Ethics approval number [1] 293473 0
ETH.5.12.076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56578 0
Dr Nicole Freene
Address 56578 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 56578 0
Australia
Phone 56578 0
+61 2 6201 5550
Fax 56578 0
Email 56578 0
[email protected]
Contact person for public queries
Name 56579 0
Nicole Freene
Address 56579 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 56579 0
Australia
Phone 56579 0
+61 2 6201 5550
Fax 56579 0
Email 56579 0
[email protected]
Contact person for scientific queries
Name 56580 0
Nicole Freene
Address 56580 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 56580 0
Australia
Phone 56580 0
+61 2 6201 5550
Fax 56580 0
Email 56580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
448Study protocol    Freene N, Del Pozo Cruz B, Davey R. Assessing the ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessing the 'active couch potato' phenomenon in cardiac rehabilitation: rationale and study protocol.2016https://dx.doi.org/10.1186/s12913-016-1313-x
EmbaseComparison of device-based physical activity and sedentary behaviour following percutaneous coronary intervention in a cohort from Sweden and Australia: A harmonised, exploratory study.2020https://dx.doi.org/10.1186/s13102-020-00164-1
EmbaseHigh sedentary behaviour and low physical activity levels at 12 months after cardiac rehabilitation: A prospective cohort study.2020https://dx.doi.org/10.1016/j.rehab.2019.07.008
EmbaseAssociation of device-measured physical activity and sedentary behaviour with cardiovascular risk factors, health-related quality-of-life and exercise capacity over 12-months in cardiac rehabilitation attendees with coronary heart disease.2022https://dx.doi.org/10.1186/s13102-022-00562-7
N.B. These documents automatically identified may not have been verified by the study sponsor.