Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000100392
Ethics application status
Approved
Date submitted
20/02/2008
Date registered
21/02/2008
Date last updated
22/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Land vs water-based exercise following total knee replacement
Scientific title
A comparison of physical and patient-centred outcomes following either a land- or water-based exercise programme following total knee replacement
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee replacement 2851 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2984 2984 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
water-based exercise. A total of 12 sessions conducted twice a week over 6 week. Each session consists of one hour of water-based aerobic, strengthening, balance and range of motion exercises
Intervention code [1] 2581 0
Rehabilitation
Comparator / control treatment
land-based exercise. A total of 12 sessions conducted twice a week over 6 week. Each session consists of one hour of land-based aerobic, strengthening, balance and range of motion exercises
Control group
Active

Outcomes
Primary outcome [1] 3864 0
Six minute walk test
Timepoint [1] 3864 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Primary outcome [2] 3872 0
Western Ontario and MacMaster University (WOMAC) Osteoarthritis Index
Timepoint [2] 3872 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Primary outcome [3] 3873 0
Range of motion (ROM) of the affected knee.
Timepoint [3] 3873 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Secondary outcome [1] 6505 0
10cm Visual Analogue Scale (VAS) of pain
Timepoint [1] 6505 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Secondary outcome [2] 6515 0
Timed ascent of stairs
Timepoint [2] 6515 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Secondary outcome [3] 6516 0
Timed descent of stairs
Timepoint [3] 6516 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Secondary outcome [4] 6517 0
Odema of the affected leg compared to the unaffected leg (cm)
Timepoint [4] 6517 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery
Secondary outcome [5] 6518 0
Body Mass Index (BMI)
Timepoint [5] 6518 0
2 weeks (initial), 8 weeks and 24 weeks post total knee replacement surgery

Eligibility
Key inclusion criteria
primary unilateral total knee replacement
Minimum age
N/A
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection or active, severe co-morbid condition as determined by an orthopaedic registrar at the time of recruitment (2 weeks post operation).

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)
Subjects were recruited when they attended a two week post-operative follow-up clinic. They were recruited by a research assistant who gave out a patient information sheet and consent form as approved by the Sydney South West Area Health Service Human Research Ethics Committee. Consenting patients then underwent the initial assessment. Following this assessment they were randomly allocated to either a land or water-based exercise program by means of consecutively numbered concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intention to treat analysis was employed.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 581 0
2164
Recruitment postcode(s) [2] 781 0
1871

Funding & Sponsors
Funding source category [1] 3102 0
Hospital
Name [1] 3102 0
Sydney South Western Area Health Service Health Research Foundation (aka Ingham Research Institute)
Country [1] 3102 0
Australia
Primary sponsor type
Hospital
Name
Sydney South Western Area Health Service Health Research Foundation (aka Ingham Research Institute)
Address
Sydney South Western Area Health Service
Research Office, Western Zone
Liverpool Hospital, Elizabeth Dr, Liverpool 2170, Sydney Australia
Country
Australia
Secondary sponsor category [1] 2794 0
Hospital
Name [1] 2794 0
Fairfield Hospital
Address [1] 2794 0
Cnr Prairievale Rd and Polding St
Prairiewood NSW 2164
Country [1] 2794 0
Australia
Secondary sponsor category [2] 2795 0
Other
Name [2] 2795 0
Whitlam Joint Replacement Centre
Address [2] 2795 0
Fairfield Hospital
Cnr Prairievale Rd and Polding St
Prairiewood NSW 2164
Country [2] 2795 0
Australia
Other collaborator category [1] 209 0
Individual
Name [1] 209 0
Dr Justine Naylor
Address [1] 209 0
Senior Research Fellow

Orthopaedics SSWAHS

Liverpool Hospital,

Elizabeth St, Liverpool, 2170

NSW, Aust
Country [1] 209 0
Australia
Other collaborator category [2] 210 0
Individual
Name [2] 210 0
A/Professor Jack Crosbie
Address [2] 210 0
Discipline of Physiotherapy
Faculty of Health Sciences,

The University of Sydney.

P.O. Box 170, Lidcombe, NSW 1825 Australia
Country [2] 210 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5081 0
Sydney South Western Area Health Service Human Rearch Ethics Committee (Western Zone)
Ethics committee address [1] 5081 0
Ethics committee country [1] 5081 0
Australia
Date submitted for ethics approval [1] 5081 0
Approval date [1] 5081 0
31/01/2005
Ethics approval number [1] 5081 0
05/006-A comparison of outcomes between land-based and water-based rehabilitation following total knee replacement

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

Contacts
Principal investigator
Name 28387 0
Address 28387 0
Country 28387 0
Phone 28387 0
Fax 28387 0
Email 28387 0
Contact person for public queries
Name 11544 0
Tyson Russell
Address 11544 0
Fairfield Hospital
Physiotherapy Department
Cnr of Prairievale Rd and Polding St
Prairiewood, NSW 2164
Country 11544 0
Australia
Phone 11544 0
0296168324
Fax 11544 0
0296168537
Email 11544 0
[email protected]
Contact person for scientific queries
Name 2472 0
Tyson Russell
Address 2472 0
Fairfield Hospital
Physiotherapy Department
Cnr of Prairievale Rd and Polding St
Prairiewood, NSW 2164
Country 2472 0
Australia
Phone 2472 0
0296168324
Fax 2472 0
0296168537
Email 2472 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.