Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000279628
Ethics application status
Not yet submitted
Date submitted
11/03/2014
Date registered
17/03/2014
Date last updated
17/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Sedentary Behaviour and Cardiac Rehabilitation
Scientific title
The effects of a behavioural intervention for reducing the sedentary behaviour among cardiac patients attending to a phase II cardiac rehabilitation program
Secondary ID [1] 284235 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary Behaviour 291347 0
Heart disease 291385 0
Condition category
Condition code
Cardiovascular 291710 291710 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 291749 291749 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated in the intervention group will undertake the usual phase II cardiac rehabilitation offered at the University of Auckland Cardiac Rehabilitation Clinic. The cardiac phase II cardiac rehabilitation program will be based on evidence-based guidelines and will be supervised by a certificated clinical exercise physiologist. A modification of two previously used behavioral-based interventions (including education on health consequences of sedentary behaviour, goal setting and advice on how to change the behaviour) will be additionally provided for these participants . The intervention will last 12 weeks. The intervention will consist on 3 educational sessions. The first session will last 30-45 minutes and the other 2 sessions 15 minutes each. The appointment will be in the week 2, 5 and 9 of the program. The different appointments will coincide with the first training day of the week. The intervention will be delivered individually based on the baseline assessments.
Intervention code [1] 288941 0
Behaviour
Comparator / control treatment
Participants allocated in the control group will undertake the usual phase II cardiac rehabilitation offered at the University of Auckland Cardiac Rehabilitation Clinic only.
Control group
Active

Outcomes
Primary outcome [1] 291652 0
Physical Activity/Sedentary Behaviour will be assessed by self-reported measure (SIT-Q-7d ) and accelerometry
Timepoint [1] 291652 0
at baseline, 12 and 16 weeks after completion of the intervention period.
Secondary outcome [1] 307233 0
Quality of life using 36-Item Short Form Health Survey version 2 (SF-36v2) and the Minnesota Living with Heart Failure Questionnaire (LIhFE)
Timepoint [1] 307233 0
at baseline, 12 and 16 weeks after completion of the intervention period.
Secondary outcome [2] 307234 0
Anxiety and Depression using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 307234 0
at baseline, 12 and 16 weeks after completion of the intervention period.
Secondary outcome [3] 307235 0
Exercise capcity will be assessed by VO2 using cardiopulmonary exercise testing cycle ergometer
Timepoint [3] 307235 0
at baseline, 12 and 16 weeks after completion of the intervention period.
Secondary outcome [4] 307237 0
Cardiometabolic health will be assessed by a lipid standard panel (triglycerides, total cholesterol, high-density lipoprotein- HDL and non-HDL) and the glucose level. Low-density lipoprotein will be determined using the Friedewald's formula A commercial available kit (Sigma-Aldrich) will be used for the assessment of the levels of the LPL.
Timepoint [4] 307237 0
at baseline, 12 and 16 weeks after completion of the intervention period.

Eligibility
Key inclusion criteria
Participants aged 18+ currently enrolled for the phase II cardiac rehabilitation program of the clinic including those who had had coronary artery bypass graft surgery (CABG), percutaneous transluminal coronary angioplasty (PTCA) or another transcatheter procedure (e.g. PTCI), myocardial infarction (MI) or valve surgery and showing a sedentary behaviour (i.e. sitting or lying down excluding sleeping and that require very low energy expenditure – between 1 and 2 METS) outside the clinics of more than 20% of the total wake time will be eligible to take part in the study
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 are unable to wear an accelerometer due to disability or if they are confined to a wheelchair

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5885 0
New Zealand
State/province [1] 5885 0
Auckland

Funding & Sponsors
Funding source category [1] 288864 0
University
Name [1] 288864 0
Faculty of Science, University of Auckland
Country [1] 288864 0
New Zealand
Primary sponsor type
University
Name
University of Auckland (Faculty of Science)
Address
Faculty of Science Student Centre
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287560 0
None
Name [1] 287560 0
Address [1] 287560 0
Country [1] 287560 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290693 0
Faculty of Science
Ethics committee address [1] 290693 0
Faculty of Science Student Centre
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 290693 0
New Zealand
Date submitted for ethics approval [1] 290693 0
25/03/2014
Approval date [1] 290693 0
Ethics approval number [1] 290693 0

Summary
Brief summary
It is well established that moderate to vigorous physical activity is associated with reduced health risk in cardiac patients. However, in addition to the generally accepted association between physical activity and health, emerging evidence suggest that sedentary behaviour is still harmful for the cardio metabolic risk factors even after controlling for physical activity. It has been also reported that almost a half of stable coronary heart patients depict a sedentary behaviour. On the other hand, it is now growing evidence that breaking sedentary behaviour confer cardio metabolic benefits to adults and some studies has shown that reduces the sedentary behaviour is possible . However, to the best of our knowledge, no studies have been conducted in cardiac rehabilitation context trying to reduce the sedentary behaviour along with keep the exercise program. We therefore aim here to test the effectiveness of new behavioural-based intervention for reducing sedentary behaviour outside the clinics in a sample of cardiac participants attending to a phase II cardiac rehabilitation program. If shown to be successful this intervention may have implications for cardiac rehabilitation research, policy and practice, and ultimately the health of cardiac patients in New Zealand and elsewhere.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46834 0
Dr Borja del Pozo Cruz
Address 46834 0
Department of Sport and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand.
Country 46834 0
New Zealand
Phone 46834 0
+64 9 373 7599 ext.86990
Fax 46834 0
Email 46834 0
b.delpozocruz@auckland.ac.nz
Contact person for public queries
Name 46835 0
Dr Borja del Pozo Cruz
Address 46835 0
Department of Sport and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand.
Country 46835 0
New Zealand
Phone 46835 0
+64 9 373 7599 ext.86990
Fax 46835 0
Email 46835 0
b.delpozocruz@auckland.ac.nz
Contact person for scientific queries
Name 46836 0
Dr Borja del Pozo Cruz
Address 46836 0
Department of Sport and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand.
Country 46836 0
New Zealand
Phone 46836 0
+64 9 373 7599 ext.86990
Fax 46836 0
Email 46836 0
b.delpozocruz@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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