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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]

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

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

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]

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]

Isometric hip abductor muscle strength, measured using a hand held dynamometer.

Timepoint [1]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Primary outcome [2]

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]

Baseline (approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [1]

Timed stair climb, a test of stair mobility.

Timepoint [1]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [2]

Timed 6 minute walk test, a test of aerobic capacity and long distance walking ability.

Timepoint [2]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [3]

Timed Up and Go, a test of mobility.

Timepoint [3]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [4]

Timed 40m fast-paced walk test, a test of short distance walking ability.

Timepoint [4]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [5]

30-second chair stand test (number of repetitions), assesses sit-to-stand ability, lower limb strength and dynamic balance.

Timepoint [5]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [6]

Step test, a functional dynamic test of standing balance.

Timepoint [6]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [7]

Isometric quadriceps muscle strength, measured using hand held dynamometer.

Timepoint [7]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [8]

Lower Extremity Functional Scale (LEFS), a self-report measure of lower extremity functional status.

Timepoint [8]

Baseline (Approximately 7 days post TKA), 3 weeks, 6 weeks, and 6 months post TKA.

Secondary outcome [9]

SF-12, overall health.

Timepoint [9]

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?

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]

Donvale Rehabilitation Hospital - Donvale

Recruitment postcode(s) [1]

3111 - Donvale

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Donvale Rehabilitation Hospital

Address [1]

1119 Doncaster Road, Donvale, Victoria, 3111

Country [1]

Australia

Primary sponsor type

Individual

Name

Margaret Schache

Address

Donvale Rehabilitation Hospital
1119 Doncaster Rd, Donvale, Victoria 3111

Country

Australia

Secondary sponsor category [1]

University

Name [1]

La Trobe University

Address [1]

Plenty Road and Kingsbury Drive, Bundoora, Victoria, 3086

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Faculty Human Ethics Committee, Faculty of Health Sciences

Ethics committee address [1]

La Trobe University
Plenty Road and Kingsbury Drive,
Bundoora, Victoria, 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/12/2014

Ethics approval number [1]

FHEC 14/256

Summary

Brief summary

The primary purpose of this study is to compare the effects of targeted hip strengthening with those of traditional care in a total knee replacement rehabilitation program. The hypotheses of this study are: 1. The targeted hip strengthening program will result in greater performance and patient reported outcomes when compared to usual care rehabilitation. 2. The targeted hip strengthening program will result in greater increases in hip strength than the usual care rehabilitation program.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Margie Schache

Address

Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111

Country

Australia

Phone

+61 3 9841 1257

Fax

[email protected]

Contact person for public queries

Name

Margie Schache

Address

Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111

Country

Australia

Phone

+61 3 9841 1257

Fax

[email protected]

Contact person for scientific queries

Name

Margie Schache

Address

Donvale Rehabilitation Hospital
1119 Doncaster Rd,
Donvale, Victoria, 3111

Country

Australia

Phone

+61 3 9841 1257

Fax

[email protected]

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.	Type	Citation	Link	Email	Other Details	Attachment
12414	Study protocol	Schache, 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.
12415	Informed consent form			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Incorporating hip abductor strengthening exercises into a rehabilitation program did not improve outcomes in people following total knee arthroplasty: a randomised trial.	2019	https://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.

Trial Review

Documents added manually

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