Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001191785
Ethics application status
Approved
Date submitted
29/08/2022
Date registered
6/09/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
6/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The AORA study- investigating the impact of physical activity and sedentary behaviour on post-operative outcomes in patients with advanced osteoarthritis requiring a total joint replacement
Scientific title
Advanced Osteoarthritis and joint Replacement surgery- investigating the associations of physical activity and sedentary behaviour with health status and post-operative outcomes
Secondary ID [1] 307862 0
Barwon Health Reference #21/224
Universal Trial Number (UTN)
Trial acronym
AORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced osteoarthritis of the hip, knee and shoulder requiring joint replacement 327481 0
Condition category
Condition code
Musculoskeletal 324605 324605 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Months
Description of intervention(s) / exposure
Physical activity and sedentary behaviour will be measured using two wearable devices that capture a diverse range of activities including sleep and activity intensity.
The thigh-mounted activPAL micro inclinometer (PAL Technologies Ltd, Glasgow, UK) will measure time spent lying, sitting, standing and stepping and will be worn for eight consecutive days at each assessment time point. The activPAL is a small, lightweight monitor worn on thigh that detects limb position using an inclinometer. The activPAL is attached using waterproof Tegaderm dressing. Raw data will be downloaded using activPAL proprietary software into event files and then processed using the ProcessingPAL software (University of Leicester, Leicester, UK) using algorithms developed for adults to determine daily sitting, standing, stepping and sleep
The wrist-mounted tri-axial GT9X ActiGraph accelerometer (Pensacola FL, USA) will also measure body position and movement, and will capture physical activity intensity and time spent sleeping. Participants will wear both monitors for eight consecutive days at each assessment time point. The timepoints that the trackers will be worn are prior to the operation (within 4 weeks), during the inpatient hospital stay following the operation, and 3 months after. Participants will then be asked to wear the trackers at 12mths and 24mths from operation. The device is removed for water-based activities (e.g. bathing) as it is not waterproof. Participants will have an initial appointment booked in person prior to their operation where the trackers will be explained and appropriately fitted, including how to troubleshoot and who to contact. This will be the only appointment face to face, otherwise trackers will be posted out. A return post envelope will be provided to return the trackers back once 8 days is complete.
Accelerometer data will be analysed in RStudio. Published prediction equations will be used to determine time spent in sedentary, light, moderate and vigorous physical activity at each assessment time point. Sleep parameters will also be obtained. Patients do not get notified of activity level through these devices.
A log book will be provided for participants to record any ActiGraph and/or activPAL removal times, as well as to document time of going to bed and time of waking. Trackers will be returned via mail.
Clinical outcomes will be assessed according to the assessment schedule and includes:
1. Joint pain
a. Numerical rating scale (0-100)
b. Oxford Score (hip, knee or shoulder)
2. Self-reported physical function
a. Oxford Score (hip, knee or shoulder)
3. Performance based measures
a. Timed 10m walk test, 30 second chair stand test, Timed up and Go Test (TUG)
4. Quality of life
a. EQ-5D-5L
5. Mental Health
a. Hospital Anxiety and Depression Scale (HADS)
6. Fear of Movement
a. Brief Fear of Movement Scale
7. Sleep quality
a. Tracker data
b. Questionnaire
8. Complications
a. Revision surgery, infection, falls, readmission to hospital
9. Global change
a. 7 point Likert scale
10. Discharge destination
a. Usual residence or inpatient rehabilitation
11. Hospital and inpatient rehabilitation length of stay
12. Analgesia requirements
Intervention code [1] 324331 0
Diagnosis / Prognosis
Comparator / control treatment
There will be no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332426 0
The primary outcome will be assessing the feasibility of using modern day tracking technology in orthopaedic surgery. This is a pilot study meaning the results will be used to dictate larger scale studies

Feasibility will be assessed through the following methods:
- Log book entries combined with reflective changes in activity tracking data
- Combining activity tracking data including step count, time spent sitting, standing, walking, and sleeping, with the other questionnaires mentioned to ensure data is accurate and reflects changes reported by the patient. The other questionnaires include- IPAQ questionnaire, Pittsburg sleep quality assessment, numerical joint pain score, oxford joint score, quality of life, mental health, and fear of movement scale
- Monitor for periods of the device being "taken off" with the use of the log book entries and feedback from activity trackers.
- Once wearing of the device is complete a semi-structured telephone interview will take place to enquire why trackers were taken off or not adhered to
Timepoint [1] 332426 0
The time points assessed are each 8 days in duration:
1. Prior to operation (within 4 weeks)
2. During the hospital stay after surgery
3. 3mths post-surgery. This will be the primary timepoint to assess for effect of intervention
4. 12mths post-surgery
5. 24mths post-surgery
Secondary outcome [1] 413452 0
Secondary outcome- activity level changes as assessed by data recorded by the activity trackers
Activity level change is defined as a % increase or decrease of step count in comparison with pre-operative levels
Timepoint [1] 413452 0
The time points assessed are each 8 days in duration:
1. Prior to operation (within 4 weeks)
2. During the hospital stay after surgery
3. 3mths post-surgery
4. 12mths post-surgery
5. 24mths post-surgery

Eligibility
Key inclusion criteria
All adult patients undergoing primary hip, knee or shoulder replacement who voluntarily participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who is not undergoing primary total hip, knee, or shoulder replacement (includes unicompartmental knee replacements, hemiarthroplasty, and revision joint replacements). Individuals deemed cognitively incapable of providing consent to participating in this study, based on the ability to consent for the operation itself, will not be included in this study. Individuals not willing to participate will be excluded from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis of quantitative data
As this is a feasibility study it is not necessary to have a fully powered study. A convenience sample of 100 participants will be recruited to the study, with approximately 50 participants recruited from each hospital. Given that 120 hip and knee joint replacements occur per month across both sites (60/site), and assuming that approximately 25% of eligible patients agree to participate, we would reach our sample size targets within 3-4 months.
Compositional analyses will be used to account for the co-dependency of the 24-hour behaviour Each 24-hour period will be divided into four behaviours (ActiGraph: sleep, sedentary, light, and moderate-to-vigorous physical activity; activPAL: sleep, sitting, standing, and stepping). The proportion of the total day spent in these behaviours will be normalized for each participant so that their sum equals one. Descriptive statistics for the components in this composition will be reported using standard statistics (i.e., range, interquartile range, and median) as well as the compositional mean (i.e., centre of the composition). The change in the composition of behaviours between time-points will be measured using by Aitchison’s perturbation method.10 Mixed models will then be used to test associations between the observed changes in the composition of movement behaviours and postoperative health outcomes (e.g. quality of life), adjusting for covariates such as age, sex and type of replacement (e.g., knee, hip). Analyses will be conducted using RStudio.
The primary outcome measure is the amount of physical activity and sedentary behaviour of participants and how this affects patients post-operatively. Clinical outcomes will be assessed with questionnaires and performance-based tasks. Validated questionnaires, such as the Oxford Score, EQ-5D-5L and HADS, will assess joint pain, physical function, quality of life, mental health, and complications from surgery. Performance-based tasks will assess walking ability with a timed walking test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
Date of last participant enrolment
Anticipated
5/09/2024
Actual
Date of last data collection
Anticipated
5/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23046 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 23047 0
St John of God Hospital, Geelong - Geelong
Recruitment postcode(s) [1] 38375 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 312139 0
University
Name [1] 312139 0
Deakin University
Country [1] 312139 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd, Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 313689 0
None
Name [1] 313689 0
Address [1] 313689 0
Country [1] 313689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311533 0
Barwon Health HREC
Ethics committee address [1] 311533 0
223 Ryrie St, Geelong VIC 3220
Ethics committee country [1] 311533 0
Australia
Date submitted for ethics approval [1] 311533 0
15/05/2022
Approval date [1] 311533 0
24/06/2022
Ethics approval number [1] 311533 0
82364

Summary
Brief summary
Aim/s, hypothesis and /or research question
This is primarily a feasibility study to ascertain the achievability of larger scale studies involving the use of activity trackers in joint replacement (and potentially other operations) patients.
Primary aim:
1. To investigate the association between PA and SB and postoperative outcomes (pain, function, quality of life, complications) and determine the composition of PA and SB (including the intensity of PA and time spent sitting, standing and sleeping) associated with better postoperative outcomes.
Secondary aim:
1. Investigate the association between preoperative PA and SB and preoperative health status (pain, function, quality of life)
2. Characterise and compare PA and SB (including the intensity of PA and time spent sitting, standing, stepping, sleeping, number of sit-to-stand transitions per day, number of bouts of prolonged sitting >30 min) in patients undergoing hip or knee replacement in the preoperative, immediate-postoperative and 3-month postoperative stages
Evidence gathered from the proposed study will be used to initiate a program of research to inform the design and implementation of larger multicentre observational and interventional studies with larger numbers of the participants and extended follow up periods.
Primary hypothesis: Post-operative outcomes will be associated with PA and SB and will be influenced by the intensity of PA performed and the amount of sedentary time. Those with higher levels of pre-operative activity will be less likely to have post-operative complications, and the inverse relating to sedentary time.
Trial website
Trial related presentations / publications
Public notes
Being physically active improves health and quality of life, whereas sedentary behaviour increases the risk of non-communicable disease and mortality. Our team has been at the forefront of this research in musculoskeletal health and demonstrated that higher levels of physical activity are associated with better bone density, muscle mass, strength and function, whereas increased sedentary behaviour was associated with an increased risk of muscle loss and sarcopenia. Despite this, the majority of adults do not achieve the recommended amount of physical activity and a large proportion of the day is spent sedentary. Increasing physical activity and reducing sedentary behaviour (PA and SB) is a major public health priority throughout the world.
Joint replacement surgery is one of the most common and successful elective surgical procedures worldwide. In Australia, more than 120,000 joint replacements are conducted each year, and this number is increasing rapidly. Hips and knees are the most commonly replaced joints and advanced osteoarthritis is the most common indication for surgery8 By 2030, the incidence of hip and knee replacements for osteoarthritis is expected to rise by 208% and 276% respectively, with a total direct cost to the healthcare system of $AUD5.32 billion. The number of shoulder replacements completed in Australia is growing rapidly and is outpacing the growth of hip and knee replacements.
People with advanced osteoarthritis are often sedentary and complete only small amounts of PA each day. For instance, a small number of high-quality studies indicate that less than one in five people with advanced hip or knee osteoarthritis achieve the recommended amount of PA for older adults according to published guidelines.10 Given that joint replacement surgery successfully improves pain and physical function, it is expected that PA and SB would improve following surgery. However, most evidence to date suggests that PA and SB does not change postoperatively, which is influenced by patient uncertainty regarding the optimum amount and type (including intensity) of PA and SB following joint replacement. Evidence is limited to a small number of studies and a recent systematic review concluded that the evidence is insufficient for determining the effects of joint replacement on PA. Only two Australian studies, with a combined total of 133 participants were identified in the review. No studies have examined how the composition of a person’s day (that is, how much time they spend engaged in PA and SB as well as sleep) effect post-operative outcomes such as pain, function, quality of life, mental health and complications.
Rehabilitation following joint replacement surgery focuses on improving pain and function with specific joint mobility and strengthening exercises, rather than broader efforts to increase habitual PA and reduce SB in daily life. No studies have investigated PA and SB during the early post-operative period when the patient is in hospital or inpatient rehabilitation, nor how this relates to post-operative outcomes. No evidence or guidelines currently exist to inform patients or health care providers regarding the optimum levels of preoperative and postoperative PA and SB that are associated with the best postoperative outcomes.
Given the increasing number of people with advanced joint disease undergoing hip, knee or shoulder replacement surgery and the importance of PA and SB for health and well-being, it is imperative that we develop a detailed understanding of the relationship between these factors. Modern wearable devices enable the objective assessment of daily PA and SB including the intensity of PA and time spent sitting, standing and sleeping. Hence, the aim of the proposed study is to compare PA and SB in people before and after joint replacement surgery of the hip, knee or shoulder using state-of-the-art wearable technology and to determine associations of PA and SB with preoperative health status and how PA and SB might impact post-operative outcomes.

Contacts
Principal investigator
Name 121438 0
Dr Henry Ring
Address 121438 0
Barwon Health
University Hospital Geelong
223 Ryrie St, Geelong VIC 3220
Country 121438 0
Australia
Phone 121438 0
+61 438248678
Fax 121438 0
Email 121438 0
henry.ring@barwonhealth.org.au
Contact person for public queries
Name 121439 0
Dr Henry Ring
Address 121439 0
Barwon Health
Orthopaedic department, University Hospital Geelong
223 Ryrie St, Geelong VIC 3220
Country 121439 0
Australia
Phone 121439 0
+61 438248678
Fax 121439 0
Email 121439 0
henry.ring@barwonhealth.org.au
Contact person for scientific queries
Name 121440 0
Dr Henry Ring
Address 121440 0
Barwon Health
Orthopaedic department, University Hospital Geelong
223 Ryrie St, Geelong VIC 3220
Country 121440 0
Australia
Phone 121440 0
+61 438248678
Fax 121440 0
Email 121440 0
henry.ring@barwonhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data from this study will be used to guide further studies using the tracking devices. Whilst obtaining and processing the data all information will not be shared outside of trial personnel and participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17058Study protocol  henry.ring@barwonhealth.org.au 384595-(Uploaded-29-08-2022-17-02-27)-Study-related document.docx
17059Ethical approval  henry.ring@barwonhealth.org.au 384595-(Uploaded-01-09-2022-12-56-23)-Study-related document.pdf
17060Informed consent form  henry.ring@barwonhealth.org.au 384595-(Uploaded-01-09-2022-12-55-34)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.