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Trial registered on ANZCTR


Registration number
ACTRN12608000359336
Ethics application status
Approved
Date submitted
14/07/2008
Date registered
25/07/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Stationary cycling versus walking: a comparison of exercise modalities following coronary artery bypass graft surgery
Scientific title
In patients undergoing first-time coronary artery bypass graft surgery, does a moderate-intensity, stationary cycling exercise program improve exercise capacity and/or health-related quality of life at hospital discharge, when compared to a moderate-intensity walking exercise program?
Secondary ID [1] 262631 0
HREC2008/3/4.7(2747) AU RED 08/WMEAD/40
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass graft surgery 3406 0
Condition category
Condition code
Cardiovascular 3553 3553 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice daily, moderate-intensity, physiotherapy-supervised stationary cycling. Sessions are undertaken morning and afternoon on subjects, while hospital inpatients, from post-operative day 3 up to and including the day prior to hospital discharge. Session durations are 10 minutes each. Subjects cycle on an electronically-braked cycle ergometer at a perceived intensity of exertion of 'moderate' to 'somewhat strong' under physiotherapy supervision, resting within the 10-minute period if/as required.
Intervention code [1] 3130 0
Treatment: Other
Intervention code [2] 3131 0
Rehabilitation
Comparator / control treatment
Twice daily, moderate-intensity, physiotherapy-supervised walking exercise. Sessions are undertaken morning and afternoon on subjects, while hospital inpatients, from post-operative day 3 up to and including the day prior to hospital discharge. Session durations are 10 minutes each. Subjects walk laps of an air-conditioned 43.5m corridor at a perceived intensity of exertion of 'moderate' to 'somewhat strong' under physiotherapy supervision, resting within the 10-minute period if/as required.
Control group
Active

Outcomes
Primary outcome [1] 4457 0
Primary Outcome 1: Modified six-minute walk assessment
Timepoint [1] 4457 0
Timepoint 1: Hospital discharge
Primary outcome [2] 4458 0
Primary Outcome 2: Six-minute cycle assessment
Timepoint [2] 4458 0
Timepoint 2: Hospital discharge
Secondary outcome [1] 7528 0
Secondary Outcome 1: Cardiac rehabilitation uptake and completion rates, using telephone administration of a 'Cardiac Rehabilitation Questionnaire' devised by the researchers
Timepoint [1] 7528 0
Timepoint 1: Six months following surgery
Secondary outcome [2] 7529 0
Secondary Outcome 2: Health related quality-of-life (Short-Form 36 version 2 (SF-36v2) subscales and physical component summary (PCS) and mental component summary (MCS) scores)
Timepoint [2] 7529 0
Timepoint 2: Hospital discharge and six months following surgery

Eligibility
Key inclusion criteria
Patients awaiting first time coronary artery bypass graft surgery at Westmead Private Hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking background, neurological or musculoskeletal conditions that would preclude exercise testing and/or training, a clinical status that necessitates emergency surgery, concomitant cardiac surgery

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)
Following individual pre-operative physiotherapy assessment and education (during which eligibility of patient to participate in study will be determined), potential participants will be provided with a Participant Information Sheet and Informed Consent to participate will be sought. Treatment group will be allocated through selection of sequentially numbered, sealed opaque envelopes (stratified by gender and history of recent myocardial infarction), the holder of the allocation schedule being 'off-site'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised sequence within each stratified group is generated from a randomisation table in a statistics book. Stratification factors include gender and history of recent myocardial infarction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3588 0
Commercial sector/Industry
Name [1] 3588 0
Westmead Private Physiotherapy Services
Address [1] 3588 0
Westmead Private Hospital, Corner of Darcy and Mons Roads, Westmead, NSW 2145
Country [1] 3588 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Physiotherapy and Exercise Science, Gold Coast Campus, Griffith University, Queensland 4222
Country
Australia
Secondary sponsor category [1] 3225 0
Commercial sector/Industry
Name [1] 3225 0
Westmead Private Physiotherapy Services
Address [1] 3225 0
Westmead Private Hospital, Corner of Darcy and Mons Roads, Westmead, NSW 2145
Country [1] 3225 0
Australia
Other collaborator category [1] 333 0
Individual
Name [1] 333 0
A/Prof David Richards
Address [1] 333 0
Westmead Private Cardiology, Suite 1, Westmead Private Hospital, Corner of Darcy and Mons Roads, Westmead, NSW 2145
Country [1] 333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5634 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 5634 0
Research Office, Room 2020 Clinical Sciences, Westmead Hospital, Hawkesbury Road, Westmead, NSW 2145
Ethics committee country [1] 5634 0
Australia
Date submitted for ethics approval [1] 5634 0
Approval date [1] 5634 0
02/04/2008
Ethics approval number [1] 5634 0
2008/3/4.7(2747) AU RED /WMEAD/40

Summary
Brief summary
Aim: To assess the comparative effects of moderate-intensity walking and stationary cycling exercise programs on early post-operative recovery following coronary artery bypass graft surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28747 0
Address 28747 0
Country 28747 0
Phone 28747 0
Fax 28747 0
Email 28747 0
Contact person for public queries
Name 11904 0
Mr Andrew Hirschhorn
Address 11904 0
Westmead Private Physiotherapy Services, Westmead Private Hospital, Corner of Darcy and Mons Roads, Westmead, NSW 2145
Country 11904 0
Australia
Phone 11904 0
(612) 8837-9000, pager #15
Fax 11904 0
Email 11904 0
andrew.hirschhorn@me.com
Contact person for scientific queries
Name 2832 0
Mr Andrew Hirschhorn
Address 2832 0
Westmead Private Physiotherapy Services, Westmead Private Hospital, Corner of Darcy and Mons Roads, Westmead, NSW 2145
Country 2832 0
Australia
Phone 2832 0
(612) 8837-9000, pager #15
Fax 2832 0
Email 2832 0
andrew.hirschhorn@me.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary