Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000757415
Ethics application status
Approved
Date submitted
6/06/2016
Date registered
9/06/2016
Date last updated
9/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise Training With A Cardiac Pacemaker
Scientific title
A Combined Home and Supervised Exercise Intervention for Patients With a Cardiac Pacemaker
Secondary ID [1] 289372 0
NIL
Universal Trial Number (UTN)
Trial acronym
EX-PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sinus Node Disease 299005 0
Atrioventricular Block 299006 0
Condition category
Condition code
Cardiovascular 299065 299065 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 299073 299073 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 16-week exercise intervention will increase moderate to vigorous physical activity towards a weekly target of >150 minutes. The program includes a weekly, 45 minute individual session with an exercise physiologist. Within each session, participants will undertake supervised exercise training, discuss strategies to improve weekly PA and an individualised, strategic exercise program will be agreed between the health professional and patient for each week to enable patients to incrementally move towards attaining the goal physical activity target within 8 weeks of the program.

Supervised exercise, alternating between treadmill walking, cycling, and rowing, will be conducted with a target heart rate of >85% peak HR (determined from baseline exercise testing) for four-minute bouts repeated four times and separated by 2 minutes of light activity as a recovery.

Home exercise will be prescribed in the moderate intensity domain with a target heart rate of 70-75% peak HR. Alternatively, patients will be prescribed activities according to the ratings of perceived exertion scale (target 12-13). The frequency of home exercise will be increased from 2 sessions per week initially, to 4 sessions per week by 3 months. Similarly, the duration of each session will begin with 20 minutes, increasing to 30 minutes by 12 weeks

Patients will maintain a journal detailing their physical activity and exercise habits. If required, additional sessions will be scheduled. 24-hour telephone and email support will be accessible to the patient.
Intervention code [1] 294959 0
Lifestyle
Intervention code [2] 294960 0
Rehabilitation
Intervention code [3] 294964 0
Treatment: Other
Comparator / control treatment
A usual care control group will be issued with written advice regarding physical activity (as per American Heart Association guidelines) at commencement of their participation in the study. Patients in the usual care group will receive risk factor management at the discretion of their treating physician. All other medical care will continue as per best-practice guidelines outlined by the American College of Cardiology and Heart Rhythm Society.
Control group
Active

Outcomes
Primary outcome [1] 298538 0
Left Ventricular Ejection Fraction Assessed by Echocardiography
Timepoint [1] 298538 0
6 months
Primary outcome [2] 298539 0
Blood Analysis of NT-BNP
Timepoint [2] 298539 0
6, 12, 18 months
Secondary outcome [1] 324515 0
Cardiorespiratory fitness, assessed by maximal exercise using pulmonary gas exchange to determine peak oxygen consumption.
Timepoint [1] 324515 0
6, 12, 18 months
Secondary outcome [2] 324516 0
Left and Right Ventricular Function Assessed by Speckle Tracking Echocardiography to Determine Peak Strain.
Timepoint [2] 324516 0
6, 12, 18mths
Secondary outcome [3] 324517 0
Quality of Life, assessed using the short-form 36 questionnaire
Timepoint [3] 324517 0
6, 12, 18 mths
Secondary outcome [4] 324518 0
Cardiac Hospitalisations as determined by review of patient records and self-report.
Timepoint [4] 324518 0
0-18 months

Eligibility
Key inclusion criteria
- Patients with a pacemaker for sinus node disease (SND) and/or atrioventricular block (AVB)
- Aged 18 - 80 years
- Current physical activity levels <60 minutes per week.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Left ventricular ejection fraction <35%
- History of myocardial infarction or cardiac surgery in past 12 months.
- NYHA Class III or IV heart failure
- Permanent atrial fibrillation
- Autoimmune or systemic inflammatory disease.
- Unable to exercise due to an existing musculoskeletal disorder.

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
4/07/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 293751 0
University
Name [1] 293751 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 293751 0
Australia
Primary sponsor type
University
Name
School of Medicine, University of Adelaide
Address
Faculty of Health Sciences
University of Adelaide
North Terrace
Adelaide
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 292580 0
Hospital
Name [1] 292580 0
Royal Adelaide Hospital
Address [1] 292580 0
Centre for Heart Rhythm Disorders
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country [1] 292580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295188 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 295188 0
Research Branch
University of Adelaide
Rundle Mall Plaza Level 4
50 Rundle Mall
Adelaide
SA 5000
Ethics committee country [1] 295188 0
Australia
Date submitted for ethics approval [1] 295188 0
Approval date [1] 295188 0
19/04/2016
Ethics approval number [1] 295188 0
H-2016-052

Summary
Brief summary
Patients with atrioventricular block and/or sinus node disease are commonly characterised by impaired functional capacity. Exercise training improves cardiorespiratory fitness, quality of life and measures of heart function. However, there is little evidence regarding the benefits of exercise training in patients requiring a pacemaker. This study will assess the benefits of exercise in this cohort, when compared with usual medical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66446 0
Prof Prashanthan Sanders
Address 66446 0
Centre for Heart Rhythm Disorders
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 66446 0
Australia
Phone 66446 0
+61 8 8222 2723
Fax 66446 0
Email 66446 0
[email protected]
Contact person for public queries
Name 66447 0
Dr Adrian Elliott
Address 66447 0
Centre for Heart Rhythm Disorders
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 66447 0
Australia
Phone 66447 0
+61882222723
Fax 66447 0
Email 66447 0
[email protected]
Contact person for scientific queries
Name 66448 0
Dr Adrian Elliott
Address 66448 0
Centre for Heart Rhythm Disorders
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 66448 0
Australia
Phone 66448 0
+61882222723
Fax 66448 0
Email 66448 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
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