Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000430538
Ethics application status
Approved
Date submitted
28/09/2006
Date registered
4/10/2006
Date last updated
2/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising shoulder and trunk movement and the ability to conduct daily activities after open heart surgery: A pilot study comparing 2 Physiotherapy treatments.
Scientific title
Optimising range of movement and function post open heart surgery: A pilot study comparing 2 Physiotherapy treatments
Secondary ID [1] 289124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post open heart surgery 1402 0
Condition category
Condition code
Surgery 1495 1495 0 0
Other surgery
Cardiovascular 1496 1496 0 0
Other surgery
Physical Medicine / Rehabilitation 1497 1497 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both intervention groups will receive standardised pre operative and post operative respiratory and mobility physiotherapy intervention.
On the day of, or prior to discharge, subjects will be randomly allocated to one of two intervention groups.

Treatment group- discharge education, walking program, thoracic mobilisation exercises to be continued post discharge until a four week post discharge follow up assessment (thereafter cardiac rehabilitation will commence).
Education program - one 30 minute session only
Walking program - twice daily, progressive and individual in nature, and therefore unable to specify duration of each session
Thoracic mobilisation - Three times daily, hence 21 sessions per week, 10-15 minutes each session
Intervention code [1] 1382 0
Treatment: Other
Comparator / control treatment
Control group - discharge education and walking program to be continued post discharge until a four week post discharge follow up assessment (thereafter cardiac rehabilitation will commence).
Control group
Active

Outcomes
Primary outcome [1] 2065 0
Thoracic and shoulder range of movement (ROM).
Timepoint [1] 2065 0
Collected at pre operative, day of / prior to discharge from acute hospital sector, four weeks post discharge, and three months post operative.
Primary outcome [2] 2066 0
Health status with the SF-36 version 2.
Timepoint [2] 2066 0
Collected at pre operative, day of / prior to discharge from acute hospital sector, four weeks post discharge, and three months post operative.
Primary outcome [3] 2067 0
Functional mobility using the Timed Up and Go.
Timepoint [3] 2067 0
Collected at pre operative, day of / prior to discharge from acute hospital sector, four weeks post discharge, and three months post operative.
Primary outcome [4] 2068 0
Pain using a body chart and VAS (Visual Analogue Scale).
Timepoint [4] 2068 0
Collected at pre operative, day of / prior to discharge from acute hospital sector, four weeks post discharge, and three months post operative.
Secondary outcome [1] 3558 0
Functional Difficulties post open heart surgery using a newly developed survey.
Timepoint [1] 3558 0
Pre operative, day of / prior to discharge from acute hospital sector, Four weeks post discharge, Three months post operatively.
Secondary outcome [2] 257838 0
Perception of the role of the physiotherapy home program contributing to physical recover. Participants will be asked "How much do you feel your physiotherapy home program contributed to your physical recovery" and rated on a 10cm visual analogue scale.
Timepoint [2] 257838 0
Following completion of the three month review

Eligibility
Key inclusion criteria
1. Subjects who are awaiting, and subsequently undergo, inpatient or elective open heart surgery via a median sternotomy at Monash Medical Centre, Clayton campus.2. Subjects who provide informed consent to participate in the pilot project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The subject is unable to complete the preoperative surveys and outcome measure tests, including instances where: the subject is transferred to MMC with insufficient time to preoperatively be assessed, they are too medically unstable to complete the preoperative tests, or if the subject is unable to give informed, written consent.2. The subject has a premorbid cognitive impairment, preventing the completion of a thoracic mobilisation exercise regimen (eg. Severe dementia).3. The subject has a premorbid severe physical impairment - where they cannot attain bilateral shoulder flexion above 90º and thus preventing the completion of thoracic mobilisation exercises (eg. Severe shoulder OA).- severe ongoing spinal and/or shoulder problems requiring treatment, which may confound results (eg rotator cuff injury).- conditions where obtaining a true sagittal image for ROM testing is difficult (eg severe scoliosis).4. The subject is unable to read English and understand spoken English.

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)
Concealed allocation with group numbers in opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Via a random number generator in Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The assessor is blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2006
Actual
2/10/2006
Date of last participant enrolment
Anticipated
Actual
1/03/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5713 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 13198 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 1632 0
Government body
Name [1] 1632 0
Monash Health, Monash Medical Centre Clayton
Country [1] 1632 0
Australia
Primary sponsor type
Individual
Name
Tamica Sturgess
Address
246 Clayton Road
Clayton VIC 3169
Country
Australia
Secondary sponsor category [1] 1435 0
Individual
Name [1] 1435 0
Dr Linda Denehy
Address [1] 1435 0
Melbourne university
Country [1] 1435 0
Australia
Secondary sponsor category [2] 1436 0
Individual
Name [2] 1436 0
Dr Elizabeth Tully
Address [2] 1436 0
Melbourne university
Country [2] 1436 0
Australia
Secondary sponsor category [3] 237184 0
Individual
Name [3] 237184 0
Dr Doa El-Ansary
Address [3] 237184 0
Melbourne University
Country [3] 237184 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3078 0
Southern Health
Ethics committee address [1] 3078 0
Ethics committee country [1] 3078 0
Australia
Date submitted for ethics approval [1] 3078 0
Approval date [1] 3078 0
14/08/2006
Ethics approval number [1] 3078 0
06071B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27609 0
Mrs Tamica Sturgess
Address 27609 0
Physiotherapy Department
Monash Medical Centre
Clayton 3168
Country 27609 0
Australia
Phone 27609 0
61 409046273
Fax 27609 0
Email 27609 0
[email protected]
Contact person for public queries
Name 10571 0
Tamica Sturgess
Address 10571 0
Physiotherapy Department
Monash Medical Centre
Locked Bag 29
Clayton South, VIC3169
Country 10571 0
Australia
Phone 10571 0
+61 3 95942250
Fax 10571 0
+61 3 95946255
Email 10571 0
[email protected]
Contact person for scientific queries
Name 1499 0
Tamica Sturgess
Address 1499 0
Physiotherapy Department
Monash Medical Centre
Locked Bag 29
Clayton South,
VIC 3169
Country 1499 0
Australia
Phone 1499 0
+61 3 95942250
Fax 1499 0
+61 3 95946255
Email 1499 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.