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Trial registered on ANZCTR


Registration number
ACTRN12611000539932
Ethics application status
Approved
Date submitted
5/05/2011
Date registered
25/05/2011
Date last updated
29/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Get Fit for Hip and Knee Joint Replacement Surgery: a pre-operative program of education, self-management and exercise for people waiting for hip and knee joint replacement surgery.
Scientific title
For people waiting for hip and knee joint replacement surgery, does a pre-operative program of education, self-management and exercise provide benefit before joint replacement?
Secondary ID [1] 260116 0
Nil
Universal Trial Number (UTN)
U1111-1121-1715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 265793 0
Knee osteoarthritis 265794 0
Condition category
Condition code
Musculoskeletal 265944 265944 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 268056 268056 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative Education and Exercise program:

The program, the 'Get Fit for Hip and Knee Joint Surgery program' is an existing group program integrating exercise and self-management strategies. The program runs at two sites within Eastern Health - Peter James Centre and Box hill Hospital. The program runs twice-weekly for six weeks. Each session comprises one hour of education/self-management and one hour of exercise (either land or pool based). All sessions are led by allied health professionals.

The education/self management component includes the following topics: self-management principles, goal setting and action plans, physical activity and osteoarthritis, pacing and activity-rest cycle, food and osteoarthritis, medications and osteoarthritis, reviewing goals, equipment needs pre and post joint replacement, and community exercise options.

The exercise component of the program will be a land-based program at Box Hill Hospital or a water-exercise program at Peter James Centre. Participants will be allocated to either land-based or water-based exercises based on personal preference and their proximity to each centre, consistent with usual practice. There is evidence that there is no difference in the outcomes of pre-operative land-based and water-based exercise programs (Gill et al 2009).
The program will contain both aerobic and muscle training exercises with exercises typically performed at moderate intensity with resistance progressed according to participant?s capability. The program will also contain functional exercises and balance training. The exercise program is designed to improve lower limb strength, endurance, flexibility, balance and general function.


Land-based exercises include:
-Exercise bike
-Rocker board
-Wobble board
-Standing one leg
-Sit to stand
-Step ups / downs
-Wall squats
-Heel Slides – to increase knee flexion range of motion
-Muscle training for knee extensors eg quadriceps over fulcrum & quads bench
-Shuttle walks
-Foot alphabet – endurance & quads control exercise

Pool Based Exercise includes:
-Walking
-Forward
-Backward
-Sideways
-Lunge walking
-Toe walking
-Lower limb ROM exercises in standing
-Hip/knee flexion
-Hip abduction / adduction
-Hip extension
-Knee flexion
-Squats
-Lower limb ROM exercise in supine
-Cycling
-Hip extension
-Hip abduction/adduction
Intervention code [1] 264533 0
Treatment: Other
Comparator / control treatment
N/A. Single group trial only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266699 0
Self efficacy as measured by the Arthritis Self Efficacy Scale (Lorig et al 1989).
Timepoint [1] 266699 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)
Secondary outcome [1] 276214 0
Pain measured with the Western Ontario and McMaster universities Osteoarthritis Index (WOMAC) pain scale.
Timepoint [1] 276214 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)
Secondary outcome [2] 276216 0
Activity measured with the WOMAC function scale
Timepoint [2] 276216 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)
Secondary outcome [3] 276217 0
Activity, as measured by fast walking speed, will be measured with the 10 m walk test. Participants will be instructed to walk as quickly as possible over a 14 m walkway, with the time taken to walk the middle 10 m measured.
Timepoint [3] 276217 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)
Secondary outcome [4] 276218 0
Activity, as measured by the 30 second chair stand test. Participants rise from a seated position to standing with arms folded across chest as many times as possible in 30 seconds.
Timepoint [4] 276218 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)
Secondary outcome [5] 276219 0
The EuroQol (EQ-5D) questionnaire and the EQ-VAS (EuroQOL, 1990) will be used to measure the participants quality of life, covering the domains of mobility; self-care; usual activities; pain/discomfort; and anxiety/depression and overall health state (EQ-VAS).
Timepoint [5] 276219 0
Week 1 and Week 4 (baseline phase)

Week 10 (post intervention)

Eligibility
Key inclusion criteria
1. Adult aged at least 18 years
2. On the waiting list (or being evaluated for) for elective hip or knee joint replacement surgery
3. Diagnosed with hip or knee osteoarthritis
4. Living independently in the community (either at home or in a retirement village)
5. Able to understand basic English. This criterion will be passed if potential participants are able to report risk factors back to recruiters after explanation of the project.
6. Received medical clearance to participate
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have severe pathology that would affect participation in the exercise component of the intervention program (e.g. severe rheumatoid arthritis, hemiparesis)
2. Live in supported accommodation (either low level of high level care)
3. Have moderate-to-severe cognitive impairment (defined as a Short Portable Mental Status Questionnaire score of less than 7 (Pfeiffer, 1975)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
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)
Recruitment postcode(s) [1] 3976 0
3125
Recruitment postcode(s) [2] 3977 0
3128
Recruitment postcode(s) [3] 3978 0
3108
Recruitment postcode(s) [4] 3979 0
3109
Recruitment postcode(s) [5] 3980 0
3103
Recruitment postcode(s) [6] 3981 0
3104
Recruitment postcode(s) [7] 3982 0
3124
Recruitment postcode(s) [8] 3983 0
3127
Recruitment postcode(s) [9] 3984 0
3129
Recruitment postcode(s) [10] 3985 0
3131
Recruitment postcode(s) [11] 3986 0
3132
Recruitment postcode(s) [12] 3987 0
3178
Recruitment postcode(s) [13] 3988 0
3150
Recruitment postcode(s) [14] 3989 0
3149
Recruitment postcode(s) [15] 3990 0
3147

Funding & Sponsors
Funding source category [1] 265019 0
Self funded/Unfunded
Name [1] 265019 0
Address [1] 265019 0
Country [1] 265019 0
Primary sponsor type
Individual
Name
Jason Wallis
Address
Box hill Hospital Physiotherpay Department
Nelson Road
Box Hill Victoria, Australia 3128
Country
Australia
Secondary sponsor category [1] 264114 0
None
Name [1] 264114 0
Address [1] 264114 0
Country [1] 264114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266997 0
Eastern health
Ethics committee address [1] 266997 0
Box Hill Hospital
5 Arnold Street,
Box Hill, Victoria, Australia 3128
Ethics committee country [1] 266997 0
Australia
Date submitted for ethics approval [1] 266997 0
27/04/2011
Approval date [1] 266997 0
26/08/2011
Ethics approval number [1] 266997 0

Summary
Brief summary
The study aims to determine if a group exercise and educational program provides benefit prior to hip or knee joint replacement surgery.

Previous research has indicated that these programs can reduce pain and improve daily activities before surgery but it is not known whether these programs can improve confidence to manage the condition (self efficacy) prior to surgery.

We will evaluate the effect of the program to be able to determine if it improves a patients confidence in managing their condition and it will also provide data that could be used to design a larger study in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32573 0
Mr Jason Wallis
Address 32573 0
Box Hill Physiotherapy Department Nelson Road, Box Hill, Victoria, Australia 3128
Country 32573 0
Australia
Phone 32573 0
+61 3 9895 3715
Fax 32573 0
Email 32573 0
jason.wallis@easternhealth.org.au
Contact person for public queries
Name 15820 0
Mr Jason Wallis
Address 15820 0
Box Hill Physiotherapy Department
Nelson Road, Box Hill, Victoria, Australia 3128
Country 15820 0
Australia
Phone 15820 0
+61 3 9895 3715
Fax 15820 0
Email 15820 0
jason.wallis@easternhealth.org.au
Contact person for scientific queries
Name 6748 0
Mr Jason Wallis
Address 6748 0
Box Hill Physiotherapy Department
Nelson Road, Box Hill, Victoria, Australia 3128
Country 6748 0
Australia
Phone 6748 0
+61 3 9895 3715
Fax 6748 0
Email 6748 0
jason.wallis@easternhealth.org.au

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