ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001013358

Ethics application status

Approved

Date submitted

3/07/2017

Date registered

14/07/2017

Date last updated

15/04/2024

Date data sharing statement initially provided

15/04/2024

Date results provided

15/04/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

TARGET study: Exercise for people with knee osteoarthritis and obesity

Scientific title

Target study: Comparison of weight bearing functional exercise and non-weight bearing quadriceps strengthening exercise on pain and function for people with knee osteoarthritis and obesity.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-3614

Trial acronym

TARGET

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Obesity

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Description of intervention(s) / exposure: This randomised controlled trial will compare two exercise interventions.

Both interventions will comprise of 5 individual, in clinic physiotherapist-supervised exercise sessions (30-40-minute) and a 4 x weekly home exercise program over the same 12 week period.

In clinic physiotherapy sessions will occur at weeks 1, 2, 4, 7 and 10.

Home exercise sessions will be approximately 20-30 minutes in duration and occur at the participants chosen time 4 times each week.

The two exercise interventions are;
i) weight bearing functional exercise which includes 5 weight bearing exercises with progressions performed using body weight resistance, elastic bands, foam mats and a small step; and,
ii) non-weight bearing quadriceps strengthening which includes 5 non-weight bearing exercises, with resistance provided by ankle weights or elastic bands.

The intensity and progressions of the exercise programs will be determined by the physiotherapist in discussion with the participant. Participants will be provided exercise equipment required.

Adherence to the exercise program will be captured via questionnaire at the 12 week time point. Adherence to the 5 clinic physiotherapy sessions will be recorded by the physiotherapists in their study case notes. Treatment fidelity will be scored by an assessment of the physiotherapist treatment notes, and fidelity will be maintained through regular tele-conferences between physiotherapists and the research team.

Intervention code [1]

Rehabilitation

Comparator / control treatment

We are comparing the effects of the two exercise groups described under “intervention”.

Control group

Active

Outcomes

Primary outcome [1]

Overall average pain in the past week on an 11-pont numeric rating scale

Timepoint [1]

Baseline and 12 weeks after baseline

Primary outcome [2]

Physical function sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
(scores will be extracted from the Knee Injury and Osteoarthritis Outcome Score (KOOS)questionnaire which contains the WOMAC questions.)

Timepoint [2]

Baseline and 12 weeks after baseline

Secondary outcome [1]

Average pain on walking in the past week on an 11-point numeric rating scale

Timepoint [1]

Baseline and 12 weeks after baseline

Secondary outcome [2]

Knee Injury and Osteoarthritis Outcome Score (KOOS)
This includes subscales
i) pain
ii) other symptoms
iii) function in sport and recreation
iv) knee related quality of life

Timepoint [2]

Baseline and 12 weeks after baseline

Secondary outcome [3]

Health related quality of life - AQoL2

Timepoint [3]

Baseline and 12 weeks after baseline

Secondary outcome [4]

Functional test 1.
30 second chair sit to stand

Timepoint [4]

Baseline and 12 weeks after baseline

Secondary outcome [5]

Functional test 2.
40m fast paced walk

Timepoint [5]

Baseline and 12 weeks after baseline

Secondary outcome [6]

Functional test 3.
6-step stair climb

Timepoint [6]

Baseline and 12 weeks after baseline

Secondary outcome [7]

Functional test 4.
Timed single leg stance

Timepoint [7]

Baseline and 12 weeks after baseline

Secondary outcome [8]

Functional test 5.
Four square test

Timepoint [8]

Baseline and 12 weeks after baseline

Secondary outcome [9]

Global change overall rated on a 7 point numeric scale from much worse to much better.

Timepoint [9]

12 weeks after baseline

Secondary outcome [10]

Global change in pain rated on a 7 point numeric scale from much worse to much better.

Timepoint [10]

12 weeks after baseline

Secondary outcome [11]

Global change in function rated on a 7 point numeric scale from much worse to much better.

Timepoint [11]

12 weeks after baseline

Secondary outcome [12]

Quadriceps muscle strength Maximum voluntary isometric strength of the knee extensors will be assessed on an isokinetic dynamometer (HUMAC) with the knee at 90 degrees of knee flexion. Maximum torque reached over 3 repetitions of 3 seconds each is recorded and normalised to body weight (Nm/kg), with higher scores indicating greater strength.

Timepoint [12]

Baseline and 12 weeks after baseline

Secondary outcome [13]

Abductor muscle strength
Maximum voluntary isometric strength of the hip abductors will be assessed using a handheld dynamometer (Lafayette Manual Muscle Test System) with the hip in neutral abduction. Average force from 2 repetitions of 3 seconds each is recorded, converted to torque and normalised to body weight (Nm/kg), with higher scores indicating greater strength.

Timepoint [13]

Baseline and 12 weeks after baseline

Eligibility

Key inclusion criteria

I. aged 50 years and above;
II. report knee pain on most days of the past month;
III. suffered knee pain for 3 months or more;
IV. report a minimum average overall pain score of 4 on an 11-point numeric rating scale over the previous week;
V. demonstrate tibiofemoral osteophytes on x-ray;
VI. obesity (BMI of 30 kg/m2 and over);
VII. have a mobile phone that has text messaging functionality and be happy to receive text message reminders if required during the study.

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

I. Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray;
II. knee surgery/joint injection in past 6 months or planned surgery in the next 9 months;
III. current or past (4 weeks) oral corticosteroids;
IV. systemic arthritic conditions;
V. past knee fracture or malignancy;
VI. past hip/knee joint replacement/tibial osteotomy;
VII. other condition currently affecting lower limb function;
VIII. participation in knee strengthening or neuromuscular exercise in past 6 months or planning to start exercise in next 9 months;
IX. unable to walk unaided;
X. unable to commit to study requirements (Unable to attend study appointments or complete study outcomes)

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)

The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. Another researcher will access the randomisation schedule via computer, concealed in a password protected database.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomization will occur according to a 1: 1 allocation and be stratified by physiotherapist and physiotherapy clinic. The randomisation schedule will be computer generated, using random permuted blocks of varying sizes. To conceal allocation, the randomisation schedule will be accessed via a password-protected, computer program by a researcher not involved in participant recruitment scheduling or assessment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering 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

Sample Size calculation: For an effect size of 0.5, power 80% and two-sided significance level 0.05, with a correlation between pre- and post-measurements of 0.45 for pain, 51 participants per arm will be required (using ANCOVA for analysis including baseline pain measurement as a covariate). To account for 20% loss to follow up, sample size will be increased to 64 per arm, for a total of 128. This gives power of 83% to detect an effect size of 0.5 for function with a correlation between pre- and post-measurements of 0.49 and a two-sided significance level of 0.05.
128 participants will be recruited and randomised.

Statistical Analysis Plan: Analyses comparing the two treatment groups will be performed by the statistician in a blinded fashion using all available data from all participants randomised to an exercise group. Demographic and baseline characteristics of participants will be summarised as appropriate (means and standard deviations for continuous variables that appear to be approximately normally distributed, medians and interquartile ranges for other continuous variables, counts and percentages for categorical variables) and will be inspected to assess baseline comparability of treatment groups. For continuous outcomes, differences in change will be compared between groups using linear regression models adjusted for baseline levels of these outcomes, including random effects for treating physiotherapist to account for clustering by physiotherapist. Model assumptions will be assessed using standard diagnostic plots. For binary outcomes, differences between groups will be compared using relative risks, calculated from logistic regression models with random effects for treating physiotherapist. Should the amount of missing data for an outcome be such that imputation is required, multiple imputation will be conducted and the method reported.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/07/2017

Actual

18/09/2017

Date of last participant enrolment

Anticipated

12/07/2019

Actual

10/05/2019

Date of last data collection

Anticipated

12/10/2019

Actual

13/08/2019

Sample size

Target

128

Accrual to date

Final

128

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

L 1 16 MARCUS CLARKE Street, Canberra Australian Capital Territory 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

1-100 Grattan Street, Melbourne, Victoria, 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee (HREC), reference number 1544919

Ethics committee address [1]

University of Melbourne, Victoria, 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2015

Approval date [1]

10/03/2017

Ethics approval number [1]

1544919

Summary

Brief summary

Knee osteoarthritis (OA) is a major public health problem with significant personal, social and economic burden.  Being overweight is a known risk factor for the development and progression of symptomatic knee OA. One potential reason may be due to the increased forces placed on the knee joint during weight bearing activities in people that are overweight. The development of targeted treatments for people at high risk of disease progression, such as those who are overweight, is a research priority. Our primary aim will therefore be to evaluate whether people with knee OA and obesity respond differently to two different types of exercise; 1) weight bearing functional exercise and ii) non-weight bearing quadriceps strengthening exercise.
Participants will be randomly allocated to one of the two exercise groups. Over 12 weeks participants will attend 5 in clinic physiotherapist appointments. The physiotherapist will prescribe a home based exercise program following the exercise protocol assigned to the participant. The home based exercise program will be completed 4 times a week, in addition to the physiotherapy sessions. Primary outcomes are overall knee pain and physical function measured at 12 weeks. 

As body mass index is easily measured our findings will potentially provide clinicians with a simple and effective means to tailor their exercise prescription and optimise outcomes for their patients with knee osteoarthritis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kim L Bennell

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010

Country

Australia

Phone

+61 3 8344 4135

Fax

k.bennell@unimelb.edu.au

Contact person for public queries

Name

Sarah Schwartz

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010

Country

Australia

Phone

+61 3 8344 8455

Fax

sarah.schwartz@unimelb.edu.au

Contact person for scientific queries

Name

Kim L Bennell

Address

L7 161 Barry Street, The University of Melbourne, Victoria, Australia,3010

Country

Australia

Phone

+61 3 8344 4135

Fax

k.bennell@unimelb.edu.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 data presented in the results paper (Osteoarthritis Cartilage. 2020 Jun;28(6):755-765.) available in XLSX format.

When will data be available (start and end dates)?

19-03-2020 to 19-03-2035 (a period of 15 years from publication)

Available to whom?

Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.

Available for what types of analyses?

The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.

How or where can data be obtained?

By emailing the Principal Investigator at k.bennell@unimelb.edu.au. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22200	Data dictionary				The Data Dictionary will be supplied with the de-i... [More Details]

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	Comparison of weight bearing functional exercise and non-weight bearing quadriceps strengthening exercise on pain and function for people with knee osteoarthritis and obesity: Protocol for the TARGET randomised controlled trial.	2019	https://dx.doi.org/10.1186/s12891-019-2662-5
Embase	What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial.	2020	https://dx.doi.org/10.1016/j.joca.2020.02.838

N.B. These documents automatically identified may not have been verified by the study sponsor.

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