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Trial registered on ANZCTR


Registration number
ACTRN12621000927820
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
15/07/2021
Date last updated
24/06/2022
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Activity Counselling Early post-Percutaneous Coronary Intervention: the ACE-PCI trial.
Scientific title
Does a 30-minute physiotherapist-led physical activity counselling session prior to hospital discharge improve daily accelerometer minutes of moderate-to-vigorous physical activity over 3-weeks in adults post-percutaneous coronary intervention compared to usual care?
Secondary ID [1] 304440 0
None
Universal Trial Number (UTN)
Trial acronym
ACE-PCI trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 322253 0
physical inactivity 322254 0
Condition category
Condition code
Cardiovascular 319939 319939 0 0
Coronary heart disease
Public Health 320210 320210 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapist-led physical activity counselling:
Participants that are allocated to the intervention group will receive a once-only 30-minute physical activity counselling session from a physiotherapist anytime prior to discharge following their PCI. The average length-of-stay in hospital following a PCI has been reported as 1–2 days. This session will be recorded in the patients medical record. Physiotherapists are well-placed to promote physical activity, with evidence that physiotherapists can counsel effectively for physical activity behaviour change, treating and considering any underlying conditions that may impair someone’s physical capacity to be physically active. Within the counselling session the physiotherapist will provide general physical activity advice, explain the benefits of physical activity, the physical activity guidelines post-PCI according to the FITT principle (frequency, intensity, time and type), barriers and enablers of physical activity, and safety measures including the warning signs of a heart attack. Exercise-based cardiac rehabilitation will also be discussed in more detail, outlining that exercise screening will be performed at the start of the program allowing a more individually tailored exercise prescription. The main purpose of this counselling session is to encourage participants to start being physically active immediately after discharge, according to their medical status, recommending light-to-moderate physical activity which is gradually progressed and motivating them to attend exercise-based cardiac rehabilitation. The total duration of the study is 3-weeks.
Intervention code [1] 320786 0
Lifestyle
Intervention code [2] 320787 0
Behaviour
Intervention code [3] 321000 0
Treatment: Other
Comparator / control treatment
Usual care:
Usual care involves very brief physical activity advice (<5 min) delivered by nursing staff prior to discharge.
Control group
Active

Outcomes
Primary outcome [1] 327814 0
Physical activity (min/day). A triaxial commercial accelerometer (ActiGraph GT3X) will be used to objectively assess physical activity. Participants will wear the monitor on their right hip during waking hours for 7-consecutive days. The triaxial accelerometer captures movement around three axes; vertical (y-axis), horizontal (x-axis) and perpendicular (z-axis).
Timepoint [1] 327814 0
Baseline and 3-weeks post-intervention commencement.
Secondary outcome [1] 396681 0
Sedentary behaviour (min/day). A triaxial commercial accelerometer (ActiGraph GT3X) will be used to objectively assess sedentary behaviour. Participants will wear the monitor on their right hip during waking hours for 7-consecutive days. The triaxial accelerometer captures movement around three axes; vertical (y-axis), horizontal (x-axis) and perpendicular (z-axis).
Timepoint [1] 396681 0
Baseline and 3-weeks post-intervention commencement..
Secondary outcome [2] 396682 0
Anxiety. The Hospital Anxiety and Depression Scale will be used for the assessment of anxiety. This questionnaire is a 14-item self-reporting questionnaire comprised of 4-point Likert-scaled items covering the occurrence of symptoms of anxiety (HADS-A) over the past 2 weeks.
Timepoint [2] 396682 0
Baseline and 3-weeks post-intervention commencement. .
Secondary outcome [3] 396683 0
Quality-of-life, The MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) will be used for the assessment of heart disease specific health-related quality of life. The MacNew is self-administered and consists of 27 items which fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks, and it has good reliability and validity internationally.
Timepoint [3] 396683 0
Baseline and 3-weeks post-intervention commencement..
Secondary outcome [4] 396685 0
Depression. The Hospital Anxiety and Depression Scale will be used for the assessment of depression. This questionnaire is a 14-item self-reporting questionnaire comprised of 4-point Likert-scaled items covering the occurrence of symptoms of depression (HADS-D) over the past 2 weeks.
Timepoint [4] 396685 0
Baseline and 3-weeks post-intervention commencement..

Eligibility
Key inclusion criteria
Eligible participants will be aged greater than or equal to 18 years and included if they have stable coronary heart disease and received a PCI +/- myocardial infarction. Eligible participants must have adequate English language and cognitive skills. Nursing staff will use clinical judgement to determine if potential participants have adequate language and cognitive skills.
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 a primary diagnosis of atrial fibrillation, 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, and are unable to walk or wear an accelerometer due to disability, for example, 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)
Group allocation will be concealed using sealed, consecutively numbered opaque envelopes. Once eligible participants are recruited and baseline measures have been taken (except accelerometry), the next envelope in the sequence will be opened to reveal random allocation to one of two groups: physiotherapist-led physical activity counselling or usual care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An investigator who is at a remote location and not involved in recruitment or assessments will use a computer to generate a random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be carried out following intention-to-treat principles. For missing data at 3-weeks, no change from baseline will be assumed. Normality of the data will be assessed using the Shapiro-Wilk test. For between group analyses, unpaired t-tests will be used for data that is normally distributed, and the Mann-Whitney U test will be used for data that was not normally distributed, using Chi-squared analysis for categorical data. For within group analyses, changes in variables with normal distributions will be analysed with paired t-tests. If variables are not normally distributed the Wilcoxon Signed Ranks tests will be used, and the McNemar test will be used for changes in proportions. All analyses will be conducted using SPSS version 27. Significance level will be set at p < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2021
Actual
9/09/2021
Date of last participant enrolment
Anticipated
14/07/2022
Actual
Date of last data collection
Anticipated
4/08/2022
Actual
Sample size
Target
30
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 19685 0
National Capital Private Hospital - Garran
Recruitment postcode(s) [1] 34317 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 308799 0
University
Name [1] 308799 0
University of Canberra
Country [1] 308799 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nicole Freene
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 309718 0
Individual
Name [1] 309718 0
Prof Rachel Davey
Address [1] 309718 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [1] 309718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308714 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 308714 0
Ethics committee country [1] 308714 0
Australia
Date submitted for ethics approval [1] 308714 0
08/06/2021
Approval date [1] 308714 0
06/07/2021
Ethics approval number [1] 308714 0
UC-HREC-9190

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

Contacts
Principal investigator
Name 111650 0
A/Prof Nicole Freene
Address 111650 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 111650 0
Australia
Phone 111650 0
+61 2 6201 5550
Fax 111650 0
Email 111650 0
nicole.freene@canberra.edu.au
Contact person for public queries
Name 111651 0
Nicole Freene
Address 111651 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 111651 0
Australia
Phone 111651 0
+61 2 6201 5550
Fax 111651 0
Email 111651 0
nicole.freene@canberra.edu.au
Contact person for scientific queries
Name 111652 0
Nicole Freene
Address 111652 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 111652 0
Australia
Phone 111652 0
+61 2 6201 5550
Fax 111652 0
Email 111652 0
nicole.freene@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Physical activity (accelerometer min/day), sedentary behaviour (accelerometer min/day) and socio-demographic variables (eg: age, gender)
When will data be available (start and end dates)?
2023 - 2027. This data will be available for 5 years.
Available to whom?
Researchers interested in physical activity following a percutaneous coronary intervention.
Available for what types of analyses?
Statistical
How or where can data be obtained?
De-identified data for this trial will be available upon request by emailing the principal investigator: nicole.freene@canberra.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.