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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
4/12/2019
Date data sharing statement initially provided
9/09/2019
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] 298351 0
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 313006 0
Condition category
Condition code
Musculoskeletal 311508 311508 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 311510 311510 0 0
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] 314591 0
Treatment: Other
Intervention code [2] 314592 0
Rehabilitation
Comparator / control treatment
The study is comparing the two modes of physiotherapy delivery.
Control group
Active

Outcomes
Primary outcome [1] 320214 0
Severity of knee pain during walking

Scored on an 11-point NRS for average pain on walking in the last week
Timepoint [1] 320214 0
Baseline, 3 months
Primary outcome [2] 320215 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [2] 320215 0
Baseline, 3 months
Secondary outcome [1] 370880 0
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] 370880 0
Baseline, 3, and 9 months
Secondary outcome [2] 370882 0
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] 370882 0
Baseline, 3, and 9 months
Secondary outcome [3] 370883 0
Arthritis self-efficacy measured by the 8-item Arthritis Self-Efficacy Scale
Timepoint [3] 370883 0
Baseline, 3 and 9 months
Secondary outcome [4] 370884 0
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] 370884 0
3 and 9 months post-baseline
Secondary outcome [5] 370885 0
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] 370885 0
3 and 9 months post-baseline
Secondary outcome [6] 370887 0
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] 370887 0
3 and 9 months post-baseline
Secondary outcome [7] 370888 0
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] 370888 0
3 and 9 months post-baseline
Secondary outcome [8] 370890 0
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] 370890 0
3 months post-baseline
Secondary outcome [9] 370891 0
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] 370891 0
3 months post-baseline
Secondary outcome [10] 370892 0
Attendance at consultations

Recorded by physiotherapists for each consultation, and by participants in an Appointment Log Book.
Timepoint [10] 370892 0
Recorded at each consultation (approximately weeks 1, 2, 4, 7, 10),
Secondary outcome [11] 370893 0
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] 370893 0
3 and 9 months post-baseline
Secondary outcome [12] 370894 0
Strengthening exercise sessions performed over the past week

Self-reported by participant in whole numbers
Timepoint [12] 370894 0
3 and 9 months post-baseline
Secondary outcome [13] 370895 0
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] 370895 0
3 and 9 months post-baseline
Secondary outcome [14] 370896 0
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] 370896 0
3 and 9 months post-baseline
Secondary outcome [15] 370897 0
Co-intervention use

Participants will complete a custom-developed survey to indicate the frequency of visits to health care providers, use of prescription and over the counter medication, injections, hospitalisation and investigative procedures for their knee pain only (and/or as a result of trial participation in the case of follow-up surveys). Retrospective recall over 3 month intervals.
Timepoint [15] 370897 0
Baseline, 3, 6 and 9 months
Secondary outcome [16] 374103 0
Severity of knee pain during walking

Scored on an 11-point NRS for average pain on walking in the last week
Timepoint [16] 374103 0
9 months post-baseline
Secondary outcome [17] 374104 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [17] 374104 0
9 months post-baseline
Secondary outcome [18] 374105 0
Participant time

Participants will record total time spent per consultation (travelling to/from, waiting and consultation time) in an Appointment Log Book.
Timepoint [18] 374105 0
At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)
Secondary outcome [19] 374106 0
Physiotherapist time

Therapists will record the total time spent in each consultation (excluding note-taking and scheduling)
Timepoint [19] 374106 0
At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)
Secondary outcome [20] 374107 0
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] 374107 0
At the conclusion of each consultation (approximately weeks 1, 2, 4, 7, 10)

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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 26593 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 302888 0
Government body
Name [1] 302888 0
National Health and Medical Research Council (NHMRC)
Address [1] 302888 0
GPO Box 1421
Canberra ACT 2601
Country [1] 302888 0
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] 302843 0
None
Name [1] 302843 0
Address [1] 302843 0
Country [1] 302843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303463 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 303463 0
Research Ethics & Integrity
The University of Melbourne
Level 1, 21 Bedford St,
North Melbourne VIC 3051
Ethics committee country [1] 303463 0
Australia
Date submitted for ethics approval [1] 303463 0
25/03/2019
Approval date [1] 303463 0
13/05/2019
Ethics approval number [1] 303463 0
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 93746 0
Prof Rana Hinman
Address 93746 0
Physiotherapy, Melbourne School of Health Sciences. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 93746 0
Australia
Phone 93746 0
+61 3 8344 3223
Fax 93746 0
Email 93746 0
ranash@unimelb.edu.au
Contact person for public queries
Name 93747 0
Mrs Penny Campbell
Address 93747 0
Level 7, CHESM. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 93747 0
Australia
Phone 93747 0
+61 3 9035 5702
Fax 93747 0
Email 93747 0
penelope.campbell@unimelb.edu.au
Contact person for scientific queries
Name 93748 0
Prof Rana Hinman
Address 93748 0
Physiotherapy, Melbourne School of Health Sciences. The University of Melbourne. Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 93748 0
Australia
Phone 93748 0
+61 3 8344 3223
Fax 93748 0
Email 93748 0
ranash@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results