Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000777099
Ethics application status
Approved
Date submitted
10/09/2010
Date registered
17/09/2010
Date last updated
24/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehabilitation to improve outcomes for patients undergoing hip and knee replacement surgery.
Scientific title
The effect of prehabilitation compared to usual care on functional outcomes and health service resource use in clients eight weeks following total knee or hip arthroplasty surgery
Secondary ID [1] 252675 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 258165 0
Condition category
Condition code
Musculoskeletal 258344 258344 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 258382 258382 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prehabilitation sessions will be 60 minutes in duration conducted by a physiotherapist. The program will be conducted twice weekly, for up to 4 weeks prior to the patients surgery date, with a maximum 6 clients per group. The exercise component will take a circuit training approach where various stations are set out that participants move around during the session. These exercises will include
1. Warm up for all at rails in standing (5 minutes)
2. Plinth – Hip knee flexion/quads over fulcrum/Hip Abduction/Bridging
3. Chair – Knee flexion and extension
4. Rails – gait re-education
5. Rails – Hip abduction/ Hip Flexion/ Hip Extension/ Squats/ Heel Raises/ Ham string curls/ calf stretch
6. Pedals/stairs/exercise bike
7. Lunges
8. Hands on therapy on plinth with Physiotherapist (Usual care rehabilitation phase) / Education station (prehabilitation phase)
Despite the circuit format, all of these exercises will have individually tailored dosages / difficulty levels set to ensure that therapeutic benefit and participant safety are maximized.
Education will also be provided to participants through provision of hip and knee care booklets with a view to clarifying the operation, pain management, gait aids, (giving a general post-surgical concept) as well as educating the patient regarding ongoing exercise at home.
Participants allocated to the intervention group will also be given a “passport” which they will be required to bring to all appointments eg. Community rehabilitation centre, their hospital inpatient stay, to have their attendance recorded and signed off by staff.
Intervention code [1] 257187 0
Rehabilitation
Comparator / control treatment
Control group participants will receive usual care as is currently practiced at Southern Health. This entails no pre-surgical exercise program. Usual care includes the provision of a hip and knee care booklet that is handed to all patients who attend pre-admission clinic.
Control group
Active

Outcomes
Primary outcome [1] 259197 0
European quality of life instrument (EQ 5D) and Visual analogue scale
Timepoint [1] 259197 0
Pre-admission clinic appointment
8 weeks post surgery
Primary outcome [2] 259198 0
The Patient-Specific Functional Scale
Timepoint [2] 259198 0
Pre-admission clinic appointment
8 weeks post surgery
Secondary outcome [1] 265566 0
Knee Range of Motion (for total knee replacement patients only) by the use of a goniometer
Timepoint [1] 265566 0
Pre-admission clinic appointment
8 weeks post surgery
Secondary outcome [2] 265567 0
Timed Up and Go Test
Timepoint [2] 265567 0
Pre-admission clinic appointment
8 weeks post surgery
Secondary outcome [3] 265568 0
Length of stay in the acute hospital setting - this information will be retrieved from the hospitals clinical information management system
Timepoint [3] 265568 0
8 weeks post surgery
Secondary outcome [4] 265569 0
Length of stay in rehabilitation in the home - this data will be retrieved from rehabilitation in the home information management system.
Timepoint [4] 265569 0
8 weeks post surgery
Secondary outcome [5] 265570 0
Proportion of patients requiring going to inpatient rehabilitation - this information will be retrieved from the hospitals clinical information management system.
Timepoint [5] 265570 0
8 weeks post surgery

Eligibility
Key inclusion criteria
Any patient undergoing a total hip replacement or total knee replacement at Monash Medical Centre Moorabbin or Dandenong Hospital who lives within the Greater Dandenong & Springvale catchment area.
Risk Assessment and Prediction Tool (RAPT) score >6.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient undergoing a total hip replacement or total knee replacement at Monash Medical Centre Moorabbin or Dandenong Hospital who does not live within the Greater Dandenong & Springvale catchment area.
If patient surgery less than three weeks away.
Unable to follow instructions/ not suitable for group setting
Revision surgeries.
Corticosteroid injection in previous six months.
Wheelchair bound patients

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)
Patients who attend preadmission clinic approximately four weeks prior to surgery will be approached for consent to participate in the program be one of the investigative team. Inclusion/exclusion criteria will be checked. A written and verbal explanation of the project will be provided. Consenting participants will then have baseline assessments administered before being randomized into the intervention (prehabilitation) or control (usual care) group. Allocation concealment will be completed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will follow a computer-generated random allocation sequence with stratification by type of surgery (knee or hip). No further stratification variables will be used in this pilot study. The random allocation sequence will be contained within opaque envelopes with numerical sequencing corresponding to the order in which participants were recruited into the trial.
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
23/09/2010
Actual
21/09/2010
Date of last participant enrolment
Anticipated
Actual
30/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3226 0
3164
Recruitment postcode(s) [2] 3232 0
3171
Recruitment postcode(s) [3] 3233 0
3172
Recruitment postcode(s) [4] 3234 0
3173
Recruitment postcode(s) [5] 3229 0
3174
Recruitment postcode(s) [6] 3225 0
3175
Recruitment postcode(s) [7] 3227 0
3803
Recruitment postcode(s) [8] 3231 0
3804
Recruitment postcode(s) [9] 3230 0
3805
Recruitment postcode(s) [10] 3228 0
3976

Funding & Sponsors
Funding source category [1] 257638 0
Self funded/Unfunded
Name [1] 257638 0
none
Country [1] 257638 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 256860 0
None
Name [1] 256860 0
Address [1] 256860 0
Country [1] 256860 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259653 0
Southern Health Human Research Ethics
Ethics committee address [1] 259653 0
Southern Health Human Research Ethics
Julie Gephart
Research Directorate
Level 4, Main Block
246 Clayton Road
Monash Medical Centre
Clayton Victoria 3168
Ethics committee country [1] 259653 0
Australia
Date submitted for ethics approval [1] 259653 0
19/08/2010
Approval date [1] 259653 0
06/09/2010
Ethics approval number [1] 259653 0
10226B

Summary
Brief summary
Currently, patients undergoing hip and knee replacement surgery do not participate in formal exercise classes prior to their operation. It is possible that the introduction of these classes may affect patients’ length of inpatient hospital stay, discharge destination, the speed of post-operative improvement (particularly movement of the affected joint) and the use of healthcare resources. Participation in exercise classes may also improve health-related quality of life following surgery.
This pilot project will examine the effect of an exercise group for patients undergoing elective hip and knee replacement surgery provided prior to their surgery (referred to herein as ‘prehabilitation’). Patients attending pre-admission clinic prior to their operation will be invited to participate in the study and included participants will be randomized to either usual care or usual care with the addition of prehabilitation.
All participants will undergo baseline testing of health-related quality of life, joint range of movement and functional activity testing in pre-admission clinic and participants will then be re-tested eight weeks following their operation. The differences between groups (usual care and usual care + prehabilitation) will be analysed using appropriate statistical tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31635 0
Mr Stuart Cavill
Address 31635 0
Monash Medical Centre Moorabbin 823-867 Centre Road East Bentleigh Victoria 3165
Country 31635 0
Australia
Phone 31635 0
+613 414 329 531
Fax 31635 0
Email 31635 0
stuart.cavill@monashhealth.org
Contact person for public queries
Name 14882 0
Mr Stuart Cavill
Address 14882 0
Monash Medical Centre Moorabbin
823-867 Centre Road
East Bentleigh
Victoria
3165
Country 14882 0
Australia
Phone 14882 0
+613 414 329 531
Fax 14882 0
+61 3 9928 8567
Email 14882 0
stuart.cavill@monashhealth.org
Contact person for scientific queries
Name 5810 0
A/Prof Terrence Haines
Address 5810 0
Director of Clinical Research, Southern Health
Kingston Centre
Warrigal Road
Cheltenham VIC 3188
Country 5810 0
Australia
Phone 5810 0
+61 3 9265 1774
Fax 5810 0
+61 3 9265 1430
Email 5810 0
Terrence.Haines@med.monash.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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