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Trial registered on ANZCTR


Registration number
ACTRN12608000415303
Ethics application status
Approved
Date submitted
4/08/2008
Date registered
22/08/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a phase one cardiac rehabilitation exercise program
Scientific title
The effect of a phase one cardiac rehabilitation education and exercise program compared to standard care in patients admitted with complications of coronary artery disease (not including open heart surgery) on functional status, quality of life and attendance at phase two cardiac rehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (acute myocardial infarction (AMI), angioplasty, stenting, unstable angina) 3504 0
Condition category
Condition code
Cardiovascular 3658 3658 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one hour education class is provided to the treatment group covering the importance of exercise and safe return to exercise / activity post acute cardiac incident.

This is combined with a short, patient specific, low intensity, monitored exercise program (including warm up, walking program and cool down), that is provided on one occasion after the education session. This intervention takes 5 to 15 minutes depending on the medical status of the patient. The focus of this session is to educate patients in appropriate exercise intensity and components of an exercise program in the first three weeks after an acute exacerbation of coronary heart disease.

The intervention is delivered on one occasion, and includes both hospital inpatients and patients recently discharged from hospital (within one week).
Intervention code [1] 3225 0
Rehabilitation
Comparator / control treatment
Standard treatment is provided to the control group. This group does not receive education about how to begin to exercise after an acute event relating to coronary heart disease, how to monitor or progress an exercise program. They are reviewed by a cardiac rehabilitation co-ordinator who provides education about modification of cardiovascular disease risk factor and referral to outpatient cardiac rehabilitation. This is a once only review that is completed prior to discharge home.
Control group
Active

Outcomes
Primary outcome [1] 4562 0
Percentage of participants attending outpatient cardiac rehabilitation
Timepoint [1] 4562 0
Six weeks after discharge
Primary outcome [2] 4563 0
Functional status assessed using the de Morton Mobility Index (DEMMI)
Timepoint [2] 4563 0
Baseline and three week follow up
Secondary outcome [1] 7716 0
Health related quality of life assessed using the MacNew and Short Form 12 (SF12) questionnaires
Timepoint [1] 7716 0
baseline and three week follow up
Secondary outcome [2] 7717 0
Walking speed ("best comfortable walking pace") over two minutes - Cardiac Two Minute Walk Test (a novel measure)
Timepoint [2] 7717 0
Baseline and three week follow up
Secondary outcome [3] 7718 0
Estimated maximal oxygen consumption (VO2Max) using a self administered questionnaire
Timepoint [3] 7718 0
Baseline and three week follow up

Eligibility
Key inclusion criteria
1. Admission to the coronary care unit with a diagnosis relating to a complication of coronary artery disease.

2. Participants who are able to return to the hospital for a three week follow up assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inpatients deemed unsuitable / unstable for exercise by their treating consultant (eg inotropic support) 2. Participants who will require open heart surgery as a result of their current admission 3. Participants who are unable to complete the outcome measures due to english as a second language or with pre-morbid cognitive impairment 4. The participant requires inpatient rehabilitation prior to discharge home 5. The participant is unable to complete the physical outcome measures due to a limitation in functional status (e.g.unable to ambulate without assistance of one or more people with their usual gait aid).

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)
Allocation was via concealment procedures: sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be utelised with two groups: Inpatients and Outpatients (as there are two populations: inpatients and recent discharges <6 days).

Each group (inpatients and outpatients) is then randomly allocated into treatment and control groups via computerised sequence generation.

Stratification was included in an attempt to create equal numbers of 'inpatients' and 'outpatients' in each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1042 0
3168

Funding & Sponsors
Funding source category [1] 3678 0
Other Collaborative groups
Name [1] 3678 0
Southern Health Research Directorate, via a "Emerging Researcher Fellowship"
Country [1] 3678 0
Australia
Primary sponsor type
Individual
Name
Danielle Ryan
Address
Physiotherapy Department
Monash Medical Centre Clayton
246 Clayton Road
(Locked Bag 29)
Clayton, Victoria
3168
Country
Australia
Secondary sponsor category [1] 3304 0
None
Name [1] 3304 0
Address [1] 3304 0
Country [1] 3304 0
Other collaborator category [1] 380 0
Individual
Name [1] 380 0
Professor Jenny Keating
Address [1] 380 0
Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences

Monash University, Peninsula Campus
PO Box 527
Frankston, Victoria, 3199
Country [1] 380 0
Australia
Other collaborator category [2] 381 0
Individual
Name [2] 381 0
Professor James Cameron
Address [2] 381 0
MonashHEART
Southern Heath
Monash Medical Centre Campus
256 Clayton Road, Clayton
Victoria Australia 3168
Country [2] 381 0
Australia
Other collaborator category [3] 382 0
Individual
Name [3] 382 0
Tamica Hoggins
Address [3] 382 0
Monash Medical Centre Clayton
Physiotherapy Department
Locked Bag 29, Clayton
Victoria, Australia 3169
Country [3] 382 0
Australia
Other collaborator category [4] 383 0
Individual
Name [4] 383 0
Doctor Terrence Haines
Address [4] 383 0
Allied Health Research Unit
Kingston Centre
Cnr Warrigal and Kingston Rds
Cheltenham, Victoria, Australia
3192
Country [4] 383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5733 0
Human Research Ethics Committe B, Southern Health Research Directorate
Ethics committee address [1] 5733 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria
3168
Ethics committee country [1] 5733 0
Australia
Date submitted for ethics approval [1] 5733 0
Approval date [1] 5733 0
14/07/2008
Ethics approval number [1] 5733 0
08102B

Summary
Brief summary
This study has been developed to assess the impact of a short (once only) education program for patients admitted to an acute hospital because of coronary artery disease. We are investigating whether early education about the importance of exercise and how to safely begin exercise after a 'heart event' will improve physical status, quality of life and confidence in completing physical activity in the early stages after acute hospitalisation. We are also investigating whether people participating in this program will be more likely to engage in cardiac rehabilitation after hospital discharge - a program that has been shown to improve function, quality of life and mortality in people with coronary artery disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28807 0
Address 28807 0
Country 28807 0
Phone 28807 0
Fax 28807 0
Email 28807 0
Contact person for public queries
Name 11964 0
Danielle Ryan
Address 11964 0
Physiotherapy Department
Monash Medical Centre
246 Clayton Road
Clayton, Victoria
3168
Country 11964 0
Australia
Phone 11964 0
95942250
Fax 11964 0
Email 11964 0
[email protected]
Contact person for scientific queries
Name 2892 0
Danielle Ryan
Address 2892 0
Physiotherapy Department
Monash Medical Centre
246 Clayton Road
Clayton, Victoria
3168
Country 2892 0
Australia
Phone 2892 0
95942250
Fax 2892 0
Email 2892 0
[email protected]

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