Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000190606
Ethics application status
Approved
Date submitted
13/02/2014
Date registered
21/02/2014
Date last updated
1/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Short term benefits of prehabilitation for Total Knee Joint Replacement (TKJR)
Scientific title
For people undergoing total knee joint replacement, does undergoing prehabilitation lead to better short term outcomes compared to not undergoing prehabilitation?
Secondary ID [1] 284092 0
None
Universal Trial Number (UTN)
U1111-1153-3082
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Joint Replacement 291166 0
Condition category
Condition code
Musculoskeletal 291500 291500 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 291544 291544 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prehabilitation consists of at least 4 (and maximum 8) physiotherapy sessions prior to TKJR surgery. The prehabilitation sessions consist of exercises aimed at increasing strength and range of motion about the knee. Education regarding the processes and expectations following a TKJR are discussed and participants practice using pick up frames and crutches to increase familiarity with methods of mobilising post surgery. The sessions are aimed at improving overall fitness, mobility, strength and confidence leading into having TKJR surgery.

Prehabilitation will aim to be 2 sessions per week for 4 weeks prior to surgery, with each session lasting 30-45 minutes (depending on progress in each session).
Intervention code [1] 288786 0
Rehabilitation
Comparator / control treatment
Usual practice prior to TKJR surgery (i.e. no physiotherapist led intervention)
Control group
Active

Outcomes
Primary outcome [1] 291474 0
Time until ready for discharge from physiotherapy.
Timepoint [1] 291474 0
Post surgery, the treating physiotherapist will assess the participant each day as part of routine practice. When the appropriate assessments reach the required level the patient will be considered ready for discharge from physiotherapy.
Secondary outcome [1] 306854 0
Length of stay
Timepoint [1] 306854 0
Length of stay will be assessed at discharge (i.e. time from surgery to discharge)
Secondary outcome [2] 306855 0
Knee Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 306855 0
Discharge and 3 months post discharge

Eligibility
Key inclusion criteria
Patients undergoing an elective TKJR at St Vincent's Private Hospital in Kew, Victoria, Australia..
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral TKJR’s/Unicompartmental Knee Replacements (UKR)
UKR
Significant co-morbidities likely to affect recovery from surgery i.e chronic condition – COPD, MS, Cardiac Condition, severe mental illness, ID, Alzhemier’s.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are invited to participate at a pre-admission appointment. Subjects nominate whether they choose to undergo prehabilitation or not. This is usual practice at the hospital where the trial will be undertaken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects nominate whether they will undertake the intervention or not. This is in line with usual practice at the hospital where the trial will take place.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of the rehabilitation and non-prehabilitation groups mean time to readiness for discharge, comparison of the mean length of stay between same groups, comparison of mean KOOS scores on discharge and 3 months later. In order to detect a difference of 0.5 days, with a SD of 3 days, 46 participants are needed per group to detect a difference with 95% confidence and 80% power. To allow for drop outs this number has been rounded up to 100.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2014
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)
VIC
Recruitment hospital [1] 2087 0
St Vincent's Private Hospital - Fitzroy

Funding & Sponsors
Funding source category [1] 288721 0
Self funded/Unfunded
Name [1] 288721 0
Unfunded
Country [1] 288721 0
Primary sponsor type
University
Name
Monash University
Address
Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199
Country
Australia
Secondary sponsor category [1] 287422 0
None
Name [1] 287422 0
Address [1] 287422 0
Country [1] 287422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290559 0
Low Risk Research Sub-committee of Human Research Ethics Committee (HREC-A)
Ethics committee address [1] 290559 0
Ethics committee country [1] 290559 0
Australia
Date submitted for ethics approval [1] 290559 0
Approval date [1] 290559 0
12/02/2014
Ethics approval number [1] 290559 0
LRR153/13

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

Contacts
Principal investigator
Name 46250 0
Dr Ross Iles
Address 46250 0
Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199
Country 46250 0
Australia
Phone 46250 0
+61 3 99044119
Fax 46250 0
Email 46250 0
[email protected]
Contact person for public queries
Name 46251 0
Ross Iles
Address 46251 0
Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199
Country 46251 0
Australia
Phone 46251 0
+61 3 99044119
Fax 46251 0
Email 46251 0
[email protected]
Contact person for scientific queries
Name 46252 0
Ross Iles
Address 46252 0
Department of Physiotherapy
Faculty of Medicine, Nursing and Health Sciences
Peninsula Campus, Monash University
McMahons Rd
Frankston
Vic 3199
Country 46252 0
Australia
Phone 46252 0
+61 3 99044119
Fax 46252 0
Email 46252 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 365798-(Uploaded-18-11-2019-09-27-41)-Basic results summary.pdf

Documents added automatically
No additional documents have been identified.