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Trial registered on ANZCTR


Registration number
ACTRN12615000863538
Ethics application status
Approved
Date submitted
20/07/2015
Date registered
18/08/2015
Date last updated
5/07/2021
Date data sharing statement initially provided
5/07/2021
Date results provided
5/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of hip strengthening on outcomes following total knee arthroplasty: a randomised controlled trial.
Scientific title
The effect of hip strengthening compared to usual care on physical performance measures following total knee arthroplasty.
Secondary ID [1] 287116 0
Nil
Universal Trial Number (UTN)
U1111-1172-3570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative total knee arthroplasty 295644 0
Condition category
Condition code
Musculoskeletal 295925 295925 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 296088 296088 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves usual care rehabilitation with additional hip strengthening exercises following total knee arthroplasty (TKA). The exercises in the usual care program are representative of usual care following TKA at Donvale Rehabilitation Hospital and focus on quadriceps, hamstring and calf muscle strengthening, and increasing knee range of movement. The exercises performed are static quadriceps contractions, knee extension over a fulcrum, forward step-ups, squats, leg press and forward step downs (for quadriceps strengthening), hamstring curls in prone and standing (for hamstring strengthening), calf raises (for calf strengthening), knee flexion, exercise bike and knee extension stretches (for increasing knee range of movement). The additional hip strengthening exercises are hip abduction, hip extension, sideways walking and hip hitching. The intervention will commence on admission to inpatient rehabilitation (approximately 7 days post-operatively). The intervention will continue for 1 hour sessions, twice daily for 10 days as an inpatient, followed by 1 hour sessions approximately twice per week for 3-4 weeks as an outpatient.The number of outpatient physiotherapy sessions delivered will be determined by the treating physiotherapist based on clinical progress. The intervention will be delivered by the treating physiotherapists. The participants will complete a home exercise program to continue the intervention independently after discharge.The exercises to be performed will be identical to those performed in the physiotherapy session with instructions for progression, e.g. the addition of resistance. The participants will be given a booklet with diagrams and descriptions of the exercises to be performed for 1 hour once daily until the final follow-up period at 6 months post-operatively. Adherence will be monitored by participant notes kept by the treating physiotherapist at the physiotherapy sessions which include the type of exercises and dosage. Following discharge from outpatient physiotherapy, patients will record daily exercises in a diary.
Intervention code [1] 292361 0
Rehabilitation
Comparator / control treatment
The control treatment is the usual care received post total knee arthroplasty at the rehabilitation hospital with additional general exercises to account for the extra time spent on hip exercises by the intervention group. The general exercises are based on improving functional activities such as sit to stand, marching and walking. The control treatment will commence on admission to inpatient rehabilitation (approximately 7 days post-operatively). The usual care treatment will continue for 1 hour sessions, twice daily for 10 days as an inpatient, followed by 1 hour sessions approximately twice per week for 3-4 weeks as an outpatient. The usual care treatment will be delivered by the treating physiotherapists. The patients will complete a home exercise program and diary to continue the intervention independently after discharge.The home exercises will be identical to those performed in the physiotherapy session with instructions for progression, e.g. the addition of resistance. The participants will be given a booklet with diagrams and descriptions of the exercises to be performed for 1 hour once daily until the final follow-up period at 6 months post-operatively. Adherence will be monitored by participant notes kept by the treating physiotherapist at the physiotherapy sessions which include the type of exercises and dosage. Following discharge from outpatient physiotherapy, patients will record daily exercises in a diary.
Control group
Active

Outcomes
Primary outcome [1] 295600 0
Isometric hip abductor muscle strength, measured using a hand held dynamometer.
Timepoint [1] 295600 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Primary outcome [2] 295766 0
Knee Injury and Osteoarthritis Outcome Score (KOOS), a self-report measure of pain, other symptoms, function in daily living and sport/recreation, and quality of life.
Timepoint [2] 295766 0
Baseline (approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [1] 315950 0
Timed stair climb, a test of stair mobility.
Timepoint [1] 315950 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [2] 315951 0
Timed 6 minute walk test, a test of aerobic capacity and long distance walking ability.
Timepoint [2] 315951 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [3] 315952 0
Timed Up and Go, a test of mobility.
Timepoint [3] 315952 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [4] 315953 0
Timed 40m fast-paced walk test, a test of short distance walking ability.
Timepoint [4] 315953 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [5] 315954 0
30-second chair stand test (number of repetitions), assesses sit-to-stand ability, lower limb strength and dynamic balance.
Timepoint [5] 315954 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [6] 315955 0
Step test, a functional dynamic test of standing balance.
Timepoint [6] 315955 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [7] 315956 0
Isometric quadriceps muscle strength, measured using hand held dynamometer.
Timepoint [7] 315956 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [8] 315958 0
Lower Extremity Functional Scale (LEFS), a self-report measure of lower extremity functional status.
Timepoint [8] 315958 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.
Secondary outcome [9] 315959 0
SF-12, overall health.
Timepoint [9] 315959 0
Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Eligibility
Key inclusion criteria
Patients will be eligible if they have had a primary unilateral total knee arthroplasty for end-stage knee osteoarthritis in the previous two weeks and are admitted for inpatient rehabilitation followed by outpatient rehabilitation at Donvale Rehabilitation Hospital.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have unstable medical conditions preventing them from participating in the rehabilitation programs, history of ipsilateral hip replacement, ipsilateral hip osteoarthritis or lateral hip pain, neurological or any other conditions affecting strength or function of the lower limbs.

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)
Eligible patients will be identified by the senior inpatient physiotherapist who is responsible for allocation of inpatients to treating physiotherapists. The treating physiotherapist will inform the patient of the study and give them the patient information sheet. If the patient is still interested in participating, the patient will meet with the researcher to discuss any questions and sign the consent form. Eligible patients will then be randomised by a computer-generated list of random numbers. The treating physiotherapist will be given a sealed opaque envelope containing the allocated group for the patient. The patients will be told that there are two different rehabilitation programs but will not be told that one program is specifically targeting hip strengthening so that they are blinded to the nature of the two arms of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated list of numbers 1 and 2 will be used to allocate patients to either the hip strengthening group or the usual care group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An estimate of sample size was obtained using a 2-tailed t-test, power=0.8, significance level of a=0.05 and 15% loss to attrition from 2 calculations. A within group calculation using data from tests of isometric hip abduction strength and KOOS function results before and after a hip strengthening exercise program estimated at least 45 patients per group will be required. To account for 15% loss to follow-up 52 participants per group will be recruited (total 104 participants).

Patient characteristics and baseline data will be summarized by descriptive statistics. T-tests for parametric data (or a chi-squared test for categorical data) will be used to determine the comparability of the two groups at baseline.
Intention to treat: any missing data will be replaced by the last observation carried forward. Repeated measures ANOVA (group by time) calculations to determine the main effects and interactions of group (hip abductor strengthening vs usual care exercises) and time (repeated factor: baseline, 3 weeks, 6 weeks, 6 months) for all outcome measures. Statistical analysis will be completed using SPSS software (version 22) and the significance level set at P<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2015
Actual
7/10/2015
Date of last participant enrolment
Anticipated
Actual
16/08/2016
Date of last data collection
Anticipated
Actual
15/02/2017
Sample size
Target
104
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4063 0
Donvale Rehabilitation Hospital - Donvale
Recruitment postcode(s) [1] 9989 0
3111 - Donvale

Funding & Sponsors
Funding source category [1] 291673 0
Hospital
Name [1] 291673 0
Donvale Rehabilitation Hospital
Country [1] 291673 0
Australia
Primary sponsor type
Individual
Name
Margaret Schache
Address
Donvale Rehabilitation Hospital
1119 Doncaster Rd, Donvale, Victoria 3111
Country
Australia
Secondary sponsor category [1] 290350 0
University
Name [1] 290350 0
La Trobe University
Address [1] 290350 0
Plenty Road and Kingsbury Drive, Bundoora, Victoria, 3086
Country [1] 290350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293202 0
Faculty Human Ethics Committee, Faculty of Health Sciences
Ethics committee address [1] 293202 0
Ethics committee country [1] 293202 0
Australia
Date submitted for ethics approval [1] 293202 0
Approval date [1] 293202 0
11/12/2014
Ethics approval number [1] 293202 0
FHEC 14/256

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

Contacts
Principal investigator
Name 58886 0
Ms Margie Schache
Address 58886 0
Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111
Country 58886 0
Australia
Phone 58886 0
+61 3 9841 1257
Fax 58886 0
Email 58886 0
schachem@ramsayhealth.com.au
Contact person for public queries
Name 58887 0
Margie Schache
Address 58887 0
Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111
Country 58887 0
Australia
Phone 58887 0
+61 3 9841 1257
Fax 58887 0
Email 58887 0
schachem@ramsayhealth.com.au
Contact person for scientific queries
Name 58888 0
Margie Schache
Address 58888 0
Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111
Country 58888 0
Australia
Phone 58888 0
+61 3 9841 1257
Fax 58888 0
Email 58888 0
schachem@ramsayhealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via web address: www.sciencedirect.com/science/article/pii/S1836955319300554


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12414Study protocolSchache, M. B., McClelland, J. A., & Webster, K. E. (2016). Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC musculoskeletal disorders, 17(1), 259.  
12415Informed consent form  schachem@ramsayhealth.com.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncorporating hip abductor strengthening exercises into a rehabilitation program did not improve outcomes in people following total knee arthroplasty: a randomised trial.2019https://dx.doi.org/10.1016/j.jphys.2019.05.008
N.B. These documents automatically identified may not have been verified by the study sponsor.