ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Coronary heart disease

Cardiovascular

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]

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]

6 minute walk test (6MWT) distance

Timepoint [1]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Primary outcome [2]

Timed up and go test (TUGT)

Timepoint [2]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Primary outcome [3]

Depression, Anxiety, Stress Score

Timepoint [3]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [1]

participation and completion rates

Timepoint [1]

Within 1 week post-rehabilitation

Secondary outcome [2]

Body Mass Index (BMI)

Timepoint [2]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [3]

Waist (cm)

Timepoint [3]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [4]

Return to work (hours/ week)

Timepoint [4]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [5]

Return to activities of daily living (ADL) (Yes/No) If no what aren't you doing?

Timepoint [5]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [6]

Knowledge Quiz

Timepoint [6]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [7]

Resting and exercsing heart rate (HR)

Timepoint [7]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [8]

Resting and exercsing diastolic and systolic blood presssure (BP)

Timepoint [8]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [9]

Exercising rate of percieved exertion (RPE)

Timepoint [9]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [10]

Blood Lipid profile

Timepoint [10]

0-8 weeks pre-rehabilitation, and 0-8 weeks prior to 6 month review

Secondary outcome [11]

Recovery Time post 6-minute walk test

Timepoint [11]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [12]

Smoking (cigarettes/week)

Timepoint [12]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [13]

Physical Activity (hours/week)

Timepoint [13]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [14]

Alcohol (standard glasses/week)

Timepoint [14]

1-2 weeks pre-rehabilitation, within 1-2 weeks post-rehabilitation, and 6 months post-rehabilitation discharge

Secondary outcome [15]

Short fat questionaire

Timepoint [15]

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?

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

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4032

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health Community Rehabilitation Workforce Project

Address [1]

Queensland Health
Charlotte St
Brisbane QLD 4000

Country [1]

Australia

Primary sponsor type

Government body

Name

Queensland Health

Address

Queensland Health
Charlotte St
Brisbane QLD 4000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Secondary sponsor category [2]

Hospital

Name [2]

The Prince Charles Hospital

Address [2]

Rode Road
Chermside QLD 4032

Country [2]

Australia

Other collaborator category [1]

University

Name [1]

Griffith University

Address [1]

Gold Coast Campus
Postal Mail Box 50 Gold Coast Mail Centre 9726

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Queensland University of Technology

Address [2]

2 George St, Brisbane QLD 4000

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Health Service District

Ethics committee address [1]

Rode Road 
Chermside QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/05/2007

Approval date [1]

30/07/2007

Ethics approval number [1]

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

Dr R. Nicole Bellet

Address

Physiotherapy Department
The Prince Charles Hospital
Rode Rd Chermside
4032

Country

Australia

Phone

61 7 31395445

Fax

[email protected]

Contact person for public queries

Name

Nicole Bellet

Address

Physiotherapy Department
The Prince Charles Hosptial
Rode Rd
Chermside QLD 4032

Country

Australia

Phone

+61 7 31394445

Fax

[email protected]

Contact person for scientific queries

Name

Nicole Bellet

Address

Physiotherapy Department
The Prince Charles Hosptial
Rode Rd
Chermside QLD 4032

Country

Australia

Phone

+61 7 31394445

Fax

[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.

Trial Review

Documents added manually

Documents added automatically