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Trial registered on ANZCTR

Registration number

ACTRN12619001240134

Ethics application status

Approved

Date submitted

21/08/2019

Date registered

9/09/2019

Date last updated

12/06/2024

Date data sharing statement initially provided

9/09/2019

Date results provided

20/05/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The PEAK Study: Physiotherapy, Exercise and physical Activity for Knee osteoarthritis

Scientific title

A non-inferiority trial comparing different modes of physiotherapy service delivery and their effect on knee pain and physical function in people with knee osteoarthritis.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1234-2473

Trial acronym

The PEAK Study

Linked study record

Health condition

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

Knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will undergo five one-on-one i) face-to-face or; ii) video consultations with a physiotherapist over 3 months (at approximately weeks 1, 2, 4, 7, 10) each lasting 30 minutes except the first which will be 45 mins. The consultations will involve the prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education.

Physiotherapists will prescribe 5-6 strengthening exercises to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training.

Participants will increase physical activity via a personalised plan developed with the therapist and will use a wearable activity tracker to assist this (for example, monitoring daily step goals). The actual physical activity plan will vary according to an individual's unique needs, preferences and physical capability, including the intensity and frequency of activity. For example, the plan for one person may be to reduce daily sedentary activity and increase incidental physical activity, while for another, the plan may aim to increase the amount of moderate-vigorous physical activity accumulated over the week. Types of physical activity will be negotiated between the physiotherapist and patient and may include any type of activity acceptable to, and feasible for, the patient.

For participants allocated to the video consultation group, these will occur via the video-conferencing facility of Zoom, a commercial cloud-based system accessible from any internet-connected computer, laptop or mobile device. Physiotherapists will consult from their clinic with participants based at home (or elsewhere if preferred). For participants allocated to face to face consultations, the consultations will occur in the physiotherapist’s own clinical rooms. Participants will travel to and from the clinic at their own expense.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

The study is comparing the two modes of physiotherapy delivery.

Control group

Active

Outcomes

Primary outcome [1]

Severity of knee pain during walking

Scored on an 11-point NRS for average pain on walking in the last week

Timepoint [1]

Baseline, 3 months

Primary outcome [2]

Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale

Timepoint [2]

Baseline, 3 months

Secondary outcome [1]

Health-related quality of life using the Assessment of Quality of Life instrument (AQoL-6D)

Scored using the 20-item Assessment of Quality of Life II Instrument (6D version), which covers the topics of Independent Living, Relationships, Mental Health, Coping, Pain and Senses to come up with one overall value representing quality of life

Timepoint [1]

Baseline, 3, and 9 months

Secondary outcome [2]

Physical Activity Scale for the Elderly (PASE)

A self-reported assessment of physical activity, covering occupational, household and leisure items over the past week with one overall value representing physical activity level.

Timepoint [2]

Baseline, 3, and 9 months

Secondary outcome [3]

Arthritis self-efficacy measured by the 8-item Arthritis Self-Efficacy Scale

Timepoint [3]

Baseline, 3 and 9 months

Secondary outcome [4]

Global improvement in knee pain

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much worse” to “much better” when compared to baseline.

Timepoint [4]

3 and 9 months post-baseline

Secondary outcome [5]

Global improvement in physical function

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much worse” to “much better” when compared to baseline.

Timepoint [5]

3 and 9 months post-baseline

Secondary outcome [6]

Global improvement in physical activity

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much less” to “much more” when compared to baseline.

Timepoint [6]

3 and 9 months post-baseline

Secondary outcome [7]

Satisfaction with the physiotherapy consultations

Scored on a 7-point global rating of change scale with response options from “extremely unsatisfied” to “extremely satisfied”.

Timepoint [7]

3 and 9 months post-baseline

Secondary outcome [8]

Working Alliance Inventory Short Form

Scored separately by both the patient and the physiotherapist, based on 12 statements relating to the perceived trust and agreement between the therapist and client, each rated on a 7-point scale

Timepoint [8]

10 weeks post-baseline (physiotherapists), 3 months post-baseline (participants)

Secondary outcome [9]

Convenience of consultations

Scored on an 11-point NRS for “Overall, how would you rate the convenience of your consultations with the physiotherapist?

Timepoint [9]

3 months post-baseline

Secondary outcome [10]

Attendance at consultations

Recorded by physiotherapists for each consultation, and by participants in an Appointment Log Book.

Timepoint [10]

Recorded at each consultation (approximately weeks 1, 2, 4, 7, 10),

Secondary outcome [11]

Adherence with strengthening exercise program

Scored on a 11-point NRS for “I have been doing my exercises exactly as I was asked to by my PEAK trial physiotherapist (number of sessions, exercises and repetitions)”

Timepoint [11]

3 and 9 months post-baseline

Secondary outcome [12]

Strengthening exercise sessions performed over the past week

Self-reported by participant in whole numbers

Timepoint [12]

3 and 9 months post-baseline

Secondary outcome [13]

Adherence with physical activity plan

Scored on a 11-point NRS for “I followed the physical activity plan that my PEAK trial physiotherapist helped me to develop”

Timepoint [13]

3 and 9 months post-baseline

Secondary outcome [14]

Adverse events

Adverse events will be self-reported by participants at 3 and 9 months, via a custom survey. Adverse events will be defined as any problem experienced in the study knee or elsewhere in the body deemed by the participant to be a result of the exercises, physical activity plans and/or advice given by the physiotherapist AND at least one of i) that caused increased pain and/or interfered with function for two days or more, and/or ii) resulted in the participant seeking treatment from a health professional. Example of adverse events may include an increase in joint pain or swelling.

Timepoint [14]

3 and 9 months post-baseline

Secondary outcome [15]

Co-intervention use
Participants will self-report any co-intervention use (medications for knee pain and any other treatments for knee OA) as part of the custom-developed survey collecting health service usage data.

Timepoint [15]

Baseline, 3, 6 and 9 months

Secondary outcome [16]

Severity of knee pain during walking

Scored on an 11-point NRS for average pain on walking in the last week

Timepoint [16]

9 months post-baseline

Secondary outcome [17]

Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale

Timepoint [17]

9 months post-baseline

Secondary outcome [18]

Participant time

Participants will record total time spent per consultation (travelling to/from, waiting and consultation time) in an Appointment Log Book.

Timepoint [18]

At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)

Secondary outcome [19]

Physiotherapist time

Therapists will record the total time spent in each consultation (excluding note-taking and scheduling)

Timepoint [19]

At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)

Secondary outcome [20]

Participant travel

Distance travelled and mode of transport to consultations (including vehicle descriptions and need for another person to accompany) will be recorded by participants in an Appointment Log Book.

Timepoint [20]

At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)

Secondary outcome [21]

Health service usage - Participants retrospectively recall their health service usage for their knee pain and/or as a result of trial participation over 3-month intervals. Participants complete a custom survey to indicate the frequency of visits to health care providers for their knee pain, use of prescription and over the counter medication, injections, hospitalisation and investigative procedures

Timepoint [21]

Baseline, 3, 6 and 9 months.

Eligibility

Key inclusion criteria

i) meet National Institute for Health and Care Excellence clinical criteria for knee OA:
i. age 45 years or older;
ii. activity-related knee joint pain;
iii. morning knee stiffness lasting no more than 30 mins,
ii) report history of knee pain of at least 3mths duration;
iii) report knee pain on most days of the past month;
iv) report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week;
v) report difficulty walking and climbing stairs;
vi) access to a device with internet connection;
vii) willing and able to travel to the nearest trial physiotherapist if required, for treatment, and;
viii) pass Exercise and Sports Science Australia stage 1 pre-exercise screening questions (consists of seven questions which are answered YES or NO, and are designed to identify individuals with signs or symptoms of underlying disease, or who may be at higher risk of an adverse event during exercise).

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

i) inability to speak English;
ii) on waiting list for/planning knee/hip surgery in next 12 months;
iii) previous arthroplasty on affected knee;
iv) recent knee surgery (past 6 months);
v) consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months);
vi) self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
vii) any neurological condition affecting lower limbs; and/or
viii) any unstable/uncontrolled cardiovascular condition.

Clearance to participate from a general practitioner will be required for anyone who i) reported a fall (past 12 months) or is house-bound due to immobility; or ii) who fails the Exercise and Sports Science Australia stage 1 pre-exercise screening questions.

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 which will be concealed in a password protected database (REDCap).

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

The randomisation schedule will be prepared by the biostatistician (permuted block sizes 6 to 12) stratified by physiotherapist. Where physiotherapists treat participants at two locations, randomisation will be stratified by location within each physiotherapist. The schedule will be stored on a password-protected website (REDCap) at Uni of Melbourne maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures.

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

Non-inferiority randomised controlled trial.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A biostatistician will analyse blinded data. Consistent with OARSI guidelines, non-inferiority will be assessed at 3 months using the per-protocol dataset (randomized participants who attended at least 3 consultations and completed primary outcomes at 3 months), as this should maximize differences between RCT arms if a difference truly exists. Between-group differences in mean change in pain and function (baseline minus follow-up) will be compared using linear regression modelling adjusted for baseline and the stratifying variable of physiotherapist. If a physiotherapist treats participants at two locations, two separate terms for that physiotherapist, corresponding to each location, will be included. Non-inferiority will be demonstrated if the lower bound of the two-sided 95% CI for between-group difference (video minus face-to-face) is above -0.95 for pain and/or -5.44 for function at 3 months. 95% CIs correspond to testing the null hypothesis of non-inferiority at a one-sided significance level of 2.5%. Due to difficulties with their interpretation, p-values associated with non-inferiority hypotheses are not commonly reported and will not be reported here.
An intention-to-treat analysis will be conducted as a sensitivity analysis with multiple imputation for missing data. Similar analyses on the intention-to-treat sample will be performed for secondary outcomes. Linear regression models will be fit to compare continuous outcomes; proportional odds models to compare improvement based on global change; and Poisson or negative binomial regression models to compare count outcomes as appropriate. Assumptions will be assessed using standard diagnostic plots and methods. If non-inferiority of the primary outcomes is demonstrated, superiority of these outcomes will then be assessed using the intention-to-treat dataset and declared if the lower bound of the two-sided 95% CI for between-group difference exceeds zero. Since these are all secondary analyses, p-values for these assessments will not be adjusted for multiple comparisons. As exploratory analyses, the moderation of the effect of video versus face-to-face on primary outcomes by pre-specified potential moderators will be assessed by including appropriate interaction terms between the moderators and the intervention term.

We will interpret and report findings transparently and separately for each primary outcome. For example, if we observe no difference in function between groups but significantly increased pain with video consultations, we will conclude that video consultations are non-inferior to face-to-face care for improving function but are inferior for pain relief, in knee OA. Patients seeking care, and physiotherapists delivering care, will then be fully informed about benefits, and limitations, of video consultations compared to face-to-face care.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/11/2019

Actual

10/12/2019

Date of last participant enrolment

Anticipated

31/08/2021

Actual

17/06/2022

Date of last data collection

Anticipated

31/05/2022

Actual

20/03/2023

Sample size

Target

394

Accrual to date

Final

394

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment postcode(s) [1]

3010 - University Of Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 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

Ethics committee address [1]

Research Ethics & Integrity
The University of Melbourne
Level 1, 21 Bedford St,
North Melbourne VIC 3051

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/03/2019

Approval date [1]

13/05/2019

Ethics approval number [1]

1953585

Summary

Brief summary

We are conducting a clinical trial  to compare the clinical effectiveness and cost-effectiveness of different modes of delivering physiotherapy care to people with knee OA. Participants will undergo five consultations with a physiotherapist over 3 months (30-45 minutes) for prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education, after which participants will be reassessed remotely via paper or web-based questionnaires at 3 months and 9 months after randomisation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

Fax

[email protected]

Contact person for public queries

Name

Penny Campbell

Address

Level 7, CHESM. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 9035 5702

Fax

[email protected]

Contact person for scientific queries

Name

Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

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 data presented in the results paper will be made available for sharing (DOI:https://doi.org/10.1016/S0140-6736(23)02630-2)

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

07/03/2024 - 07/03/2039 (a period of 15 years from publication)

Available to whom?

Data will be made available to researchers as required for specific, approved analyses. 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 ([email protected]). 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
23738	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	Technology versus tradition: A non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial.	2020	https://dx.doi.org/10.1186/s12891-020-03523-8
Embase	Evaluation of a novel e-learning program for physiotherapists to manage knee osteoarthritis via telehealth: Qualitative study nested in the PEAK (Physiotherapy exercise and physical activity for knee osteoarthritis) randomized controlled trial.	2021	https://dx.doi.org/10.2196/25872

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

Trial Review

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