Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000880640
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
16/08/2023
Date last updated
16/08/2023
Date data sharing statement initially provided
16/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two resources on pre-surgical physical activity and motivation for patients with hip/knee osteoarthritis
Scientific title
A Minimal Intervention to Assess Motivation for Pre-Surgical Physical Activity Behaviour in Adults Undergoing Total Hip or Knee Arthroplasty due to Severe Osteoarthritis
Secondary ID [1] 310244 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Motivation for PreHAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 330944 0
Knee osteoarthritis 330946 0
Prehabilitation 330947 0
Physical activity motivation 330948 0
Behaviour change 330949 0
Pre-surgical physical activity 330950 0
Arthroplasty 331066 0
Condition category
Condition code
Surgery 327752 327752 0 0
Other surgery
Physical Medicine / Rehabilitation 327753 327753 0 0
Other physical medicine / rehabilitation
Musculoskeletal 327754 327754 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a behavioural intervention to assess the impact of PreHAB: Pre-arthroplasty Home-based physical Activity Booklet on pre-surgical physical activity and motivation (based on constructs within the Capability-Opportunity-Motivation-Behaviour (COM-B) Model of Behaviour). PreHAB has been designed specifically for this study and has been informed by findings from previous studies over the past 2 years by the doctoral researcher and with support from the co-investigators with expertise in psychology of physical activity and behaviour change and (clinical) exercise physiology.

PreHAB is a patient- and clinician-informed, osteoarthritis-specific home-based pre-surgical physical activity resource for those awaiting arthroplasty. PreHAB is a resource booklet containing a home-based exercise programme, with information about the programme that reinforces the importance of pre-surgical physical activity and the appropriateness of the exercise for lower osteoarthritis, the importance of keeping active before surgery and what previous research has shown regarding this, how patients can have a role in their pre-surgical health, past-patient quotes and modelling/images and descriptions of how to perform each exercise, encouragement and ideas for exercise progress (e.g., sets, reps, number of days, duration) throughout the 12wk study, and worksheets for patients to consider their own motivations, action planning (with examples), barrier planning (with examples), and logsheets to record each week's action plan and exercise participation.

PreHAB contains several behaviour change techniques (BCTs), such as goal setting, problem solving, action planning, review of goals, self-monitoring of behaviour, skills training/instruction, information about health consequences, information about antecedents, prompts/cues, restructuring the social environment, adding objects to the environment, framing/reframing, verbal persuasion about capability, and focus on past success. The BCTs listed above are non-exhaustive regarding those which have been incorporated in PreHAB, and further information can be requested if required.

The physical activity programme in the booklet provides the participant with 9 exercises (descriptions + pictures of how to perform the exercise), and encouragement to incorporate some walking if they feel up to it. The exercises are a combination of upper and lower body strength exercises, such as side and front raises and knee pull-aparts, performed with an elastic resistance band (provided with the booklet). Participants are asked to aim to perform the exercises at least three times a week for 10 minutes or more, initially doing as many reps of each exercise as they can manage in Week 1, and are provided with suggested ways to progress each week if they think they can manage it. Participants can decide for themselves when and how often they do the exercises, and write this on their action plan worksheets for each week; they record each session and number of reps on their logbook sheets for each week.

Patients will be randomised by the doctoral researcher to receive PreHAB and a theraband or the control (usual care leaflet) at their hospital-scheduled anaesthetic appointment OR surgeon appointment. As such, there are two intervention arms: PreHAB @ Anaesthetic Appointment and PreHAB @ Surgeon Appointment. These appointments generally occur at least 4 months before surgery. The appointment clinician will hand participants the allocated intervention or control resource; the clinician will not discuss either resource beyond the usual verbal information they provide patients about being active before surgery. Patients can direct their questions to members of the research team, whose contact details are provided to them on the Participant Information Sheet.

Patients who consent to participate will be asked questionnaires over the phone before their scheduled appointment and across the 12 weeks following their scheduled appointment.
Intervention code [1] 326641 0
Behaviour
Comparator / control treatment
The control treatment is the usual care leaflet ("Are Your Fit For Surgery?", Southern Health District) handed out at the anaesthetic or surgeon appointments. The leaflet is provided to patients and encourages them to be fit for surgery, with information and recommendations around activity and getting fit for surgery, as well as other health behaviours (e.g., smoking cessation, limiting alcohol, medication adherence, weight management and diet).

As such, there are two control arms: Leaflet @ Anaesthetic Appointment and Leaflet @ Surgeon Appointment.

Patients who consent to participate will be asked questionnaires over the phone before their scheduled appointment and across the 12 weeks following their scheduled appointment.
Control group
Active

Outcomes
Primary outcome [1] 335552 0
Change in physical activity as assessed by the Stanford 7-Day Physical Activity Recall
Timepoint [1] 335552 0
Multiple timepoints: 1 week pre-appointment (baseline), 3 days post-appointment, 3 weeks post-appointment, 6 weeks post-appointment, 12 weeks post-appointment (primary timepoint)
Secondary outcome [1] 424930 0
Change in capability, opportunity, motivation score as assessed by a COM-B Model of Behaviour questionnaire
Timepoint [1] 424930 0
Multiple timepoints: 1 week pre-appointment (baseline), 3 days post-appointment, 3 weeks post-appointment, 6 weeks post-appointment, 12 weeks post-appointment
Secondary outcome [2] 424931 0
Change in osteoarthritis index score as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index.
Timepoint [2] 424931 0
Multiple timepoints: 1 week pre-appointment (baseline), 3 days post-appointment, 3 weeks post-appointment, 6 weeks post-appointment, 12 weeks post-appointment
Secondary outcome [3] 424932 0
Intervention Acceptability as measured by a questionnaire designed specifically for this study to provide more specific insight on subjective outcomes and acceptability of this behavioural intervention; administered to participants who receive PreHAB in the study.
Timepoint [3] 424932 0
12 weeks post-appointment

Eligibility
Key inclusion criteria
Patients waitlisted through Dunedin Public Hospital for total hip or knee arthroplasty due to severe osteoarthritis
Answer “no” to the following binary question: “Do you currently do any exercise that increases your heart rate or breathing rate for more than 150 min per week?”
Medical clearance to participate in the study provided by clinical staff following orthopaedic or anaesthetic assessment prior to beginning PreHAB; those who are not provided clearance following their assessment will be withdrawn from the study by the study researchers and will continue with usual care.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not have severe osteoarthritis
Have not been approved for surgery nor cleared by attending clinical staff to participate in PreHAB
Perform more than 150 minutes of exercise per week

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Assuming a power of 0.8 and an alpha level of 0.05, the required sample size per group is n=64. Assuming 10% attrition and an allocation ratio of 1:1:1:1, we will recruit 70 participants per group or 280 participants in total from August 2023 to April 2024 for the 12-week intervention.

Statistical analysis will be conducted using SPSS (IMB, USA). The D'Agostino and Pearson omnibus test will be used to test for normality of data. Normally distributed data will be expressed as mean +/- standard deviation and non-parametric data expressed as median and interquartile range. An analysis of covariance (ANCOVA) using self-efficacy score will test for significant between-group differences in baseline and post-appointment follow-up. Non-parametric testing will test for significant differences between non-normally distributed variables. A significance level of 0.05 will be used for all tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 25682 0
New Zealand
State/province [1] 25682 0
Dunedin, Otago

Funding & Sponsors
Funding source category [1] 314452 0
University
Name [1] 314452 0
University of Otago (Doctoral Scholarship)
Country [1] 314452 0
New Zealand
Primary sponsor type
Individual
Name
Jessica Calverley
Address
School of Physical Education, Sport and Exercise Sciences, University of Otago
55 Union St W, Dunedin, Otago, New Zealand 9016
Country
New Zealand
Secondary sponsor category [1] 316399 0
Individual
Name [1] 316399 0
Associate Professor Dr Elaine Hargreaves
Address [1] 316399 0
School of Physical Education, Sport and Exercise Sciences, University of Otago
55 Union St W, Dunedin, Otago, New Zealand 9016
Country [1] 316399 0
New Zealand
Other collaborator category [1] 282772 0
Individual
Name [1] 282772 0
Dr Kate Thomas
Address [1] 282772 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
201 Great King St, Dunedin, Otago, New Zealand 9016
Country [1] 282772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313503 0
NZ Ministry of Health, Health and Disability Ethics Committee (Southern)
Ethics committee address [1] 313503 0
Health and Disability Ethics Committee, Ministry of Health
133 Molesworth St, PO Bx 5013, Wellington, New Zealand 6011
Ethics committee country [1] 313503 0
New Zealand
Date submitted for ethics approval [1] 313503 0
Approval date [1] 313503 0
28/07/2023
Ethics approval number [1] 313503 0
2023EXP15624

Summary
Brief summary
Prehabilitation aims to increase pre-op physical activity participation and maintain fitness/function and health to reduce surgical risks and improve post-op outcomes. Achieving this requires patients to be motivated to want to increase their activity levels and adhere to pre-op physical activity recommendations. For those with hip/knee osteoarthritis awaiting arthroplasty (joint replacement), increasing pain, stiffness, and immobility can make this a challenge, compounded by prolonged waits for surgery. Many prehabilitation research interventions lack strategies that can create motivation to achieve physical activity behaviour change. Further, usual pre-op care typically provides recommendations to patients in the form of a leaflet about staying fit in the waiting period in preparation for surgery, yet these can be non-specific and often require patients to independently change their behaviour to improve physical activity participation.

Using the COM-B Model of Behaviour as a framework, previous PhD research with patients and clinicians identified capability (physical and psychological) as the primary behavioural driver of motivation for pre-op activity. Patients felt their motivation for physical activity would occur/be strengthened both following their appointment with the orthopaedic surgeon and at the Anaesthetic Clinic. Patients and clinicians shared their perspectives and feedback on what information would be necessary for and pertinent to motivate pre-op activity. This information was used to inform and design an arthroplasty-specific home-based physical activity booklet (dubbed: PreHAB) that incorporates effective behaviour change techniques and includes information which patients and clinicians highlighted as important or potentially significant in supporting behaviour change and pre-op physical activity.

This study aims to assess the impact of PreHAB compared to the usual care leaflet on patients' physical activity and COM constructs (capability, opportunity, motivation) across 12 weeks. As patients identified two potential timepoints for physical activity motivation (orthopaedic surgeon appointment and Anaesthetic Clinic), this study will also assess whether one of these timepoints creates a stronger change in physical activity and COM scores.

Participants will respond to questionnaires over the phone once before their appointment and randomly receive either PreHAB or usual care leaflet at their appointment. Participants will be phoned again for questionnaire responses across 12 weeks following their appointment. Questionnaires assess: physical activity in the previous 7 days; capability, opportunity and motivation for physical activity; osteoarthritis severity; and intervention acceptability [at study completion].
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128358 0
Ms Jessica Calverley
Address 128358 0
School of Physical Education, Sport and Exercise Sciences, University of Otago,
55 Union St W, Dunedin, New Zealand 9016
Country 128358 0
New Zealand
Phone 128358 0
+64 3 479 8941
Fax 128358 0
Email 128358 0
[email protected]
Contact person for public queries
Name 128359 0
Jessica Calverley
Address 128359 0
School of Physical Education, Sport and Exercise Sciences, University of Otago,
55 Union St W, Dunedin, New Zealand 9016
Country 128359 0
New Zealand
Phone 128359 0
+64 3 479 8941
Fax 128359 0
Email 128359 0
[email protected]
Contact person for scientific queries
Name 128360 0
Jessica Calverley
Address 128360 0
School of Physical Education, Sport and Exercise Sciences, University of Otago,
55 Union St W, Dunedin, New Zealand 9016
Country 128360 0
New Zealand
Phone 128360 0
+64 3 479 8941
Fax 128360 0
Email 128360 0
[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?
De-identified participant datasets of published results only from across the 13week intervention (1 week pre-appointment, 12 weeks post-appointment)
When will data be available (start and end dates)?
Immediately following publication, no end date yet determined
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



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.