Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001382369
Ethics application status
Approved
Date submitted
26/09/2017
Date registered
28/09/2017
Date last updated
28/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise, Physical Activity and Nurse-Led Education for Patients with an Implantable Cardioverter Defibrillator
Scientific title
A STructured Exercise, Physical Activity, and Education Intervention in Patients with an ICD: The STEP-ICD Pilot Study
Secondary ID [1] 292982 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 304886 0
sudden cardiac death 304887 0
Condition category
Condition code
Cardiovascular 304202 304202 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to the intervention group will undergo a 12-week, goal orientated,
combined home and supervised exercise intervention. Weekly exercise will increase progressively in duration from 45 minutes per week in week 1 to 210 minutes per week by week 12. All patients in the intervention arm will attend a supervised exercise clinic once per fortnight for 15-30 minutes with the remainder of exercise being predominantly home-based and monitored by a wearable accelerometer and heart rate tracking device. Exercise will be prescribed according to individualised intensities (using a rating of perceived exertion scale) by an accredited exercise physiologist. Exercise will be predominantly aerobic exercise throughout, with the addition of bodyweight resistance training in week 8. Furthermore, the intervention will include an education component, led by a cardiovascular nurse, regarding disease and device management. Specifically, patients will meet with a study nurse three times through the intervention (week 1, 4, and 8) to discuss and receive education on, their heart condition, how their cardiac devices works, their cardiovascular risk factors and any anxieties or concerns that they may have,
Intervention code [1] 299223 0
Rehabilitation
Comparator / control treatment
Participants in the control group will continue to receive optimal medical care for their heart condition according to international guidelines. This varies between patients according to their underlying pathology but may include the continuation of medications including diuretics, beta-blockers, and anti-hypertensive medication.
Control group
Active

Outcomes
Primary outcome [1] 303504 0
Peak Oxygen Consumption assessed by cardiopulmonary exercise testing
Timepoint [1] 303504 0
12 weeks, 24 weeks
Secondary outcome [1] 339108 0
Weekly moderate-vigorous physical activity (MVPA) assessed by accelerometry. This metric will also be used to aseess study feasibility by quantifying the amount of physical activity each patients is achieving, comapred to that being recommended.
Timepoint [1] 339108 0
12 weeks, 24 weeks
Secondary outcome [2] 339109 0
Minnesota Living with Heart Failure Score assessed by questionnaire
Timepoint [2] 339109 0
12 weeks, 24 weeks
Secondary outcome [3] 339110 0
Hospital Anxiety and Depression Score assessed by questionnaire
Timepoint [3] 339110 0
12 weeks, 24 weeks

Eligibility
Key inclusion criteria
- Primary prevention implanted cardioverter defibrillator (ICD), without cardiac resynchronization therapy (CRT-D), implanted within past 35 days
- Aged >18 - 80 years
- LV Ejection Fraction <45%.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severely impaired cognitive function, restricting informed consent.
- Severely limited walking capacity.
- New York Heart Association Class I or IV
- Sustained ventricular arrhythmias during baseline cardiopulmonary exercise testing.
- Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC/D)

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/10/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297607 0
University
Name [1] 297607 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 297607 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
Level 8, South Australian Health & Medical Research Institute
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 296621 0
None
Name [1] 296621 0
Address [1] 296621 0
Country [1] 296621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298700 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 298700 0
Ethics committee country [1] 298700 0
Date submitted for ethics approval [1] 298700 0
Approval date [1] 298700 0
19/09/2017
Ethics approval number [1] 298700 0

Summary
Brief summary
This study will provide novel, translational data by evaluating the feasibility and efficacy of a structured, goal directed, exercise and physical activity intervention, coupled with nurse-led education, initiated within one month of implant, for patients receiving a primary prevention ICD.
Across Australia, there are ~4000 new recipients of an implanted cardioverter defibrillator
(ICD) annually. Recipients are commonly those with left ventricular (LV) dysfunction and/or inducible ventricular arrhythmia. Annual all-cause mortality in patients with prophylactic ICD implantation is approximately 5.0 to 8.5% . Additionally, ICD recipients report lower
quality of life coupled with both anxiety and depressive symptoms, which may be exaggerated by higher prevalence of inactivity.
The rationale for this study is therefore to combine nurse-led education with a physical activity intervention in new recipients of a primary prevention ICD. Both interventions are clinically effective in patients with heart failure or an ICD, yet have not been comprehensively assessed in a combined strategy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77938 0
Dr Adrian Elliott
Address 77938 0
Level 8, South Australian Health & Medical Research Institute
North Terrace
Adelaide
SA 5000
Country 77938 0
Australia
Phone 77938 0
+61 8 8222 2723
Fax 77938 0
Email 77938 0
[email protected]
Contact person for public queries
Name 77939 0
Adrian Elliott
Address 77939 0
Level 8, South Australian Health & Medical Research Institute
North Terrace
Adelaide
SA 5000
Country 77939 0
Australia
Phone 77939 0
+61 8 8222 2723
Fax 77939 0
Email 77939 0
[email protected]
Contact person for scientific queries
Name 77940 0
Adrian Elliott
Address 77940 0
Level 8, South Australian Health & Medical Research Institute
North Terrace
Adelaide
SA 5000
Country 77940 0
Australia
Phone 77940 0
+61 8 8222 2723
Fax 77940 0
Email 77940 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.