Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000697987
Ethics application status
Not yet submitted
Date submitted
23/06/2011
Date registered
7/07/2011
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
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. (Study 2)
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 after joint replacement?
Secondary ID [1] 262394 0
Nil
Universal Trial Number (UTN)
U1111-1122-2753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 268100 0
Knee osteoarthritis 268269 0
Condition category
Condition code
Musculoskeletal 268243 268243 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the same as the intervention for the current ANZCTR registered trial (study 1) (ACTRN12611000539932, http://www.anzctr.org.au/ACTRN12611000539932.aspx).

Please note: The aim of study 1 (ACTRN12611000539932) is to determine the benefit of the intervention BEFORE joint replacement surgery. The aim of this study (study 2) is to determine the benefit of the same intervention AFTER joint replacement. Some of the participants in study 2 may have participated in study 1.

The details of the intervention are detailed below:


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 participants 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] 266784 0
Treatment: Other
Comparator / control treatment
Case control participants are adult, did not complete the pre-operative program, and are matched for their case for age (within 5 years), gender, and operation (e.g. joint replaced, whether cemented or non-cemented components, number of compartments replaced if knee replacement).
Control group
Active

Outcomes
Primary outcome [1] 268975 0
Items from the Functional Independence Measure (FIM) mobility scale that are relevant during early post-operative recovery will be rated by a physiotherapist who will be blind to the group.

The following tasks will be evaluated:
1. Transfer out of bed,
2. Sit to stand
3. Walking.

The (FIM) (Hamilton and Granger, 1994) assesses the amount of assistance required to complete activities on a 7-point scale.
Timepoint [1] 268975 0
Day 3 Post operatively
Secondary outcome [1] 276734 0
Hospital Utilisation:
1. Discharge destination, either to home, rehabilitation, low level care, high level care, or other
2. Length of stay during hospital admission
Timepoint [1] 276734 0
At discharge from hospital
Secondary outcome [2] 276735 0
The De Morton Mobility index (DEMMI) a 15 item uni-dimensional measure of mobility (De Morton et al., 1998).
Timepoint [2] 276735 0
Day 3 post-operatively
Secondary outcome [3] 276736 0
Arthritis self efficacy scale (Lorig et al 1989)
Timepoint [3] 276736 0
Day 3 post-operatively
Secondary outcome [4] 276737 0
Hospital Anxiety and Depression (HADS) scale. The HADS is a 14-item self-report scale designed to briefly measure current anxiety and depressive symptoms in non-psychiatric hospital patients.
Timepoint [4] 276737 0
Day 3 post-operatively

Eligibility
Key inclusion criteria
1. Adult aged at least 18 years
2. Living independently in the community (either at home or in a retirement village)
3. Able to understand basic English.
4. Completed the get fit for hip and knee joint replacement program within 3 months of surgery.
5. Case control participants will be eligible to participate provided they are adult, did not complete the pre-operative program, and are matched for their case for age (within 5 years), gender, and operation (e.g. joint replaced, whether cemented or non-cemented components, number of compartments replaced if knee replacement).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. They did not complete their pre-operative intervention within 3 months of surgery, so that the intervention might reasonably be expected to have had some effect.
2. Have a significant complication post-operatively that would affect participation in the assessment at day 3 post-operatively.
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
Other
Other design features
A case control design will be used to evaluate post-operative outcomes between participants who complete the group program and those who do not.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4122 0
3125
Recruitment postcode(s) [2] 4123 0
3128
Recruitment postcode(s) [3] 4124 0
3108
Recruitment postcode(s) [4] 4125 0
3109
Recruitment postcode(s) [5] 4126 0
3103
Recruitment postcode(s) [6] 4127 0
3104
Recruitment postcode(s) [7] 4128 0
3124
Recruitment postcode(s) [8] 4129 0
3127
Recruitment postcode(s) [9] 4130 0
3129
Recruitment postcode(s) [10] 4131 0
3131
Recruitment postcode(s) [11] 4132 0
3132
Recruitment postcode(s) [12] 4133 0
3178
Recruitment postcode(s) [13] 4134 0
3150
Recruitment postcode(s) [14] 4135 0
3149
Recruitment postcode(s) [15] 4136 0
3147

Funding & Sponsors
Funding source category [1] 267288 0
Self funded/Unfunded
Name [1] 267288 0
Country [1] 267288 0
Primary sponsor type
Individual
Name
Jason Wallis
Address
Box Hill Hospital Physiotherapy Department
Nelson Road
Box Hill Victoria, Australia 3128
Country
Australia
Secondary sponsor category [1] 266349 0
None
Name [1] 266349 0
Address [1] 266349 0
Country [1] 266349 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269282 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 269282 0
5 Arnold Street
Box Hill Hospital
Victoria 3128
Website: www.easternhealth.org.au/ethics
Ethics committee country [1] 269282 0
Australia
Date submitted for ethics approval [1] 269282 0
23/06/2011
Approval date [1] 269282 0
Ethics approval number [1] 269282 0
E60/1011

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

Previous research has indicated that these programs do not provide much benenfit post-operatively, especially post knee replacement.

We will evaluate if patients who receive the intervention reach functional milestones during hospital stay more quickly after surgery than patients who do not complete the program. 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 32752 0
Dr Jason Wallis
Address 32752 0
Monash Department of Clinical Epidemiology,
4 Drysdale Street, Malvern, Victoria, 3144
Country 32752 0
Australia
Phone 32752 0
+61 3 9508 1700
Fax 32752 0
Email 32752 0
[email protected]
Contact person for public queries
Name 15999 0
Dr Jason Wallis
Address 15999 0
Monash Department of Clinical Epidemiology,
4 Drysdale Street, Malvern, Victoria, 3144
Country 15999 0
Australia
Phone 15999 0
+61 3 9508 1700
Fax 15999 0
Email 15999 0
[email protected]
Contact person for scientific queries
Name 6927 0
Dr Jason Wallis
Address 6927 0
Monash Department of Clinical Epidemiology,
4 Drysdale Street, Malvern, Victoria 3144
Country 6927 0
Australia
Phone 6927 0
+61 3 9508 1700
Fax 6927 0
Email 6927 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data collected


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.