Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000593437
Ethics application status
Approved
Date submitted
26/08/2007
Date registered
19/11/2007
Date last updated
23/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fast-track versus traditional cardiac rehabilitation: clinical outcomes and the use of the 6-minute walk test.
Scientific title
Fast-track versus Traditional cardiac rehabilitation Phase II: clinical outcomes and the use of the 6-minute walk test
Secondary ID [1] 288362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participants in Community Based Phase II Cardiac Rehabilitation - including post open heart surgery (OHS) and acute coronary syndrome (ACS) and post-angiolplasty/stent 2298 0
Condition category
Condition code
Cardiovascular 2395 2395 0 0
Coronary heart disease
Cardiovascular 2453 2453 0 0
Coronary heart disease
Cardiovascular 2663 2663 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cardiac Rehabilitation - fast track (1 x 1 hour/week exercise and 1 full day - 8 hours - of education) over 6 weeks
Intervention code [1] 2015 0
Rehabilitation
Comparator / control treatment
Cardiac Rehabilitation - traditional (2 x 1 hour/week exercise and 2 x 1 hour/week of education sessions) over 6 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 3295 0
6 minute walk test (6MWT) distance
Timepoint [1] 3295 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Primary outcome [2] 3296 0
Timed up and go test (TUGT)
Timepoint [2] 3296 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Primary outcome [3] 3297 0
Depression, Anxiety, Stress Score
Timepoint [3] 3297 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [1] 5481 0
participation and completion rates
Timepoint [1] 5481 0
Within 1 week post-rehabilitation
Secondary outcome [2] 5482 0
Body Mass Index (BMI)
Timepoint [2] 5482 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [3] 5483 0
Waist (cm)
Timepoint [3] 5483 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [4] 5484 0
Return to work (hours/ week)
Timepoint [4] 5484 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [5] 5485 0
Return to activities of daily living (ADL) (Yes/No) If no what aren't you doing?
Timepoint [5] 5485 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [6] 5486 0
Knowledge Quiz
Timepoint [6] 5486 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [7] 5487 0
Resting and exercsing heart rate (HR)
Timepoint [7] 5487 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [8] 5488 0
Resting and exercsing diastolic and systolic blood presssure (BP)
Timepoint [8] 5488 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [9] 5489 0
Exercising rate of percieved exertion (RPE)
Timepoint [9] 5489 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [10] 5490 0
Blood Lipid profile
Timepoint [10] 5490 0
0-8 weeks pre-rehabilitation, and 0-8 weeks prior to 6 month review
Secondary outcome [11] 5491 0
Recovery Time post 6-minute walk test
Timepoint [11] 5491 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [12] 5492 0
Smoking (cigarettes/week)
Timepoint [12] 5492 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [13] 5493 0
Physical Activity (hours/week)
Timepoint [13] 5493 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [14] 5494 0
Alcohol (standard glasses/week)
Timepoint [14] 5494 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge
Secondary outcome [15] 5759 0
Short fat questionaire
Timepoint [15] 5759 0
1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Eligibility
Key inclusion criteria
All Patients for exercise and education component of the program who provide informed consent to participate
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not consent to participation will be allotted to groups as per normal protocol and although included in sessions will not have their data used in the analysis.
Patients who for practical reasons cannot participate in the study e.g. inability to perform functional tests.
Patients whose language prevents easy reading/understanding of educational material unless interpreter services are available.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated numbers
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
20/08/2007
Actual
7/08/2007
Date of last participant enrolment
Anticipated
Actual
11/03/2008
Date of last data collection
Anticipated
Actual
12/11/2008
Sample size
Target
160
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 236 0
4032

Funding & Sponsors
Funding source category [1] 2553 0
Government body
Name [1] 2553 0
Queensland Health Community Rehabilitation Workforce Project
Country [1] 2553 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Queensland Health
Charlotte St
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 2312 0
None
Name [1] 2312 0
Address [1] 2312 0
Country [1] 2312 0
Secondary sponsor category [2] 2443 0
Hospital
Name [2] 2443 0
The Prince Charles Hospital
Address [2] 2443 0
Rode Road
Chermside QLD 4032
Country [2] 2443 0
Australia
Other collaborator category [1] 17 0
University
Name [1] 17 0
Griffith University
Address [1] 17 0
Gold Coast Campus
Postal Mail Box 50 Gold Coast Mail Centre 9726
Country [1] 17 0
Australia
Other collaborator category [2] 278779 0
University
Name [2] 278779 0
Queensland University of Technology
Address [2] 278779 0
2 George St, Brisbane QLD 4000
Country [2] 278779 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4479 0
The Prince Charles Hospital Health Service District
Ethics committee address [1] 4479 0
Rode Road
Chermside QLD 4032
Ethics committee country [1] 4479 0
Australia
Date submitted for ethics approval [1] 4479 0
30/05/2007
Approval date [1] 4479 0
30/07/2007
Ethics approval number [1] 4479 0
2760

Summary
Brief summary
Part A:
Australian Cardiac rehabilitation phase II programs are traditionally conducted over 6 to 8 weeks combining education and exercise sessions. Exercise training is considered to require between six and eight weeks. Increasing exercise and achieving life style changes with long term adherence are the main aims of cardiac rehabilitation. Programs with reduced contact hours would allow greater accessibility to patients and suit patients returning quickly to their life roles, however, it is unclear if these provide similar benefits to traditional programs involving 2-3 sessions a week. The current study aims to compare outcomes and costs in the same community setting between two six week programs with a) 1 exercise session a week and one education day or b) 2 exercise and 2 education sessions per week.
Hypothesis:
Outcomes will be statistically similar for participants in either the fast track or traditional program.


Part B:

The aims of exercise testing in cardiac rehabilitation are to provide an outcome measure for the exercise component of the program and to provide information on exercise safety and exercise capacity of the participant. The six minute walk test is a ‘functional’ exercise test which is commonly implemented utilising two to three repeated tests to obtain maximal walking distance for an individual. This is time consuming and the benefit of multiple testing in this setting is unclear. The timed up and go test is commonly used in the aged care setting. The aims of this study are to determine in the cardiac population if a) repeated 6MWT at assessment /reassessment is mandatory for outcome measurement or exercise prescription and b) the Timed up and go test could provide an equally effective outcome measure as the 6MWT.Hypothesis:
1. The 6MWT and TUGT similarly demonstrate improvements in exercise capacity in the cardiac rehabilitation population
2. The difference between the first 6MWT and the second 6MWT at a given point in time i.e. at commencement, at discharge and at 6 months is consistent and hence only one test is required for outcome measurement purposes.
3. The difference between the second TUGT and the third TUGT at commencement, at discharge and at 6 months is consistent and hence only two tests are required for outcome measurement purposes.
4. The TUGT can be used to prescribe exercise level in the cardiac rehabilitation population.
Trial website
Trial related presentations / publications
Bellet, RN, Francis RL, Adams L, Morris NR. "Six-Minute Walk Test Distances in Fast-Track and Traditional Cardiac Rehabilitation: A 3-YEAR DATABASE REVIEW." Journal of Cardiopulmonary Rehabilitation Prevention 2015; 35(6): 417-422.
Public notes

Contacts
Principal investigator
Name 28006 0
Dr R. Nicole Bellet
Address 28006 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside
4032
Country 28006 0
Australia
Phone 28006 0
61 7 31395445
Fax 28006 0
Email 28006 0
[email protected]
Contact person for public queries
Name 11163 0
Dr Nicole Bellet
Address 11163 0
Physiotherapy Department
The Prince Charles Hosptial
Rode Rd
Chermside QLD 4032
Country 11163 0
Australia
Phone 11163 0
+61 7 31394445
Fax 11163 0
Email 11163 0
[email protected]
Contact person for scientific queries
Name 2091 0
Dr Nicole Bellet
Address 2091 0
Physiotherapy Department
The Prince Charles Hosptial
Rode Rd
Chermside QLD 4032
Country 2091 0
Australia
Phone 2091 0
+61 7 31394445
Fax 2091 0
Email 2091 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.