Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001281987
Ethics application status
Approved
Date submitted
23/09/2020
Date registered
26/11/2020
Date last updated
26/11/2020
Date data sharing statement initially provided
26/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Modifying activity behaviours in osteoarthritis
Scientific title
The best activity is the next activity: the effect of replacing sitting with moving on pain in people with osteoarthritis
Secondary ID [1] 302309 0
Nil
Universal Trial Number (UTN)
U1111-1257-2439
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 319172 0
Condition category
Condition code
Public Health 317141 317141 0 0
Health promotion/education
Musculoskeletal 317142 317142 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 317143 317143 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with mild hip or knee osteoarthritis will take part in a behaviour change intervention which will take place over an 8-week period. During this time, participants will complete 3 motivational interviewing (MI) sessions (weeks 1-4) and 2 integrated MI-cognitive behaviour theory (CBT) sessions (weeks 5-8). Each session will last approximately 30 minutes and will be delivered in a one-to-one format. At least 1 of each session may take place in person. The remaining sessions will be delivered through an online video conferencing platform. A researcher who is trained in the MI-CBT techniques will deliver the intervention. As MI is effective for initiating behaviour change, information will be used to identify possible target areas for change where sedentary behaviour can be swapped for some form of light physical activity. Cognitive behaviour theory will be used to set those goals using self-generated options on methods to allow participants to reduce their time spent sitting by engaging in activities such as light walking, gardening or light household activities regularly into their day. A session diary will be kept by the researcher containing examples of open-ended questions and MI techniques for the researcher. The diary will also be used to record notes on participant responses in the session and during the CBT sessions will record targets for behaviour change. Attendance and completion of the number of sessions will be recorded to monitor adherence to the MI-CBT intervention.
Intervention code [1] 318665 0
Behaviour
Intervention code [2] 318666 0
Lifestyle
Intervention code [3] 318667 0
Prevention
Comparator / control treatment
Usual care.
Usual care is the routine care offered by participants' own general practitioner and other healthcare providers. No MI-CBT intervention will be received by participants in the usual care group. The researchers will neither influence nor restrict GPs', surgeons’, other practitioners’ or participants’ use of other interventions, however it will be monitored and recorded.
Control group
Active

Outcomes
Primary outcome [1] 325216 0
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to assess knee-related function.
Timepoint [1] 325216 0
Baseline (pre-intervention) and 8 weeks after the commencement of the MI-CBT intervention
Primary outcome [2] 325217 0
The Hip dysfunction and Osteoarthritis Outcome Score (HOOS) questionnaire will be used to assess hip disability related to the osteoarthritis.
Timepoint [2] 325217 0
Baseline (pre-intervention) and 8 weeks after the commencement of the MI-CBT intervention
Secondary outcome [1] 387214 0
The Exercise Self-Efficacy scale.
Timepoint [1] 387214 0
Baseline (pre-intervention) and 8 weeks after the commencement of the MI-CBT intervention
Secondary outcome [2] 387215 0
The Behavioural Regulation in Exercise Questionnaire.
Timepoint [2] 387215 0
Baseline (pre-intervention) and 8 weeks after the commencement of the MI-CBT intervention
Secondary outcome [3] 387216 0
The Numeric Pain Rating Scale
Timepoint [3] 387216 0
Baseline (pre-intervention) and every 2 weeks during the 8-week intervention period
Secondary outcome [4] 387217 0
The Fear Avoidance Beliefs Questionnaire
Timepoint [4] 387217 0
Baseline (pre-intervention) and every 2 weeks during the 8-week intervention period
Secondary outcome [5] 387220 0
Time spent in light physical activity, objectively measured using a waist-worn actigraph.
Timepoint [5] 387220 0
Baseline (pre-intervention) and every 2 weeks during the 8-week intervention period
Secondary outcome [6] 388349 0
Time spent in sedentary behaviour, objectively measured using a thigh-worn activPAL
Timepoint [6] 388349 0
Baseline (pre-intervention) and every 2 weeks during the 8-week intervention
Secondary outcome [7] 388350 0
Time spent in moderate to vigorous intensity physical activity, objectively measured using a waist-worn actigraph. MVPA is a composite secondary outcome.
Timepoint [7] 388350 0
Baseline (pre-intervention) and every 2-weeks during the 8-week intervention.

Eligibility
Key inclusion criteria
Men and women will be eligible for inclusion in the study if they have been diagnosed with hip or knee osteoarthritis as per the American Rheumatism Association (ACR) criteria and classified with minimal osteoarthritis (Kellgren-Lawrence grade less than or equal to 2), are between 40 and 80 years of age, have a body mass index between 20 to 35 kg/m2, and are ambulant with or without assistive devices.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are a BMI lower than 20 or higher than 35 kg/m2, a scheduled uni/bilateral joint arthroplasty, a second joint arthroplasty or revision during the intervention, co-morbidities or medical conditions that affect their ability to take part in physical activity, a diagnosis of arthritis other than osteoarthritis or non-ambulant or wheel chair-bound.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Linear mixed models

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2021
Actual
Date of last participant enrolment
Anticipated
12/04/2021
Actual
Date of last data collection
Anticipated
7/06/2021
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 23012 0
New Zealand
State/province [1] 23012 0
Auckland

Funding & Sponsors
Funding source category [1] 306738 0
University
Name [1] 306738 0
University of Auckland
Country [1] 306738 0
New Zealand
Primary sponsor type
Individual
Name
Rebecca Meiring
Address
Department of Exercise Sciences
University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 307287 0
None
Name [1] 307287 0
Address [1] 307287 0
Country [1] 307287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306909 0
Health and Disability Ethics Committee
Ethics committee address [1] 306909 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 306909 0
New Zealand
Date submitted for ethics approval [1] 306909 0
02/09/2020
Approval date [1] 306909 0
11/09/2020
Ethics approval number [1] 306909 0
20/CEN/200

Summary
Brief summary
The objectives of this study will be to deliver a behavioural intervention through several sessions of integrated motivational interviewing (MI) and cognitive behaviour therapy (CBT) over an 8-week period in people with mild hip or knee osteoarthritis. All participants will be invited to take part in an education session after which participants will be randomised into a behavioural intervention group or a usual care group. Participants in the intervention group will continue to engage in an integrated motivational interviewing and cognitive behaviour change theory intervention for 8 weeks. Participants in the control group will receive the usual care from their primary healthcare provider for the same 8 weeks. Patient reported outcomes measures of joint pain, overall OA-related physical function, health-related quality of life and self-efficacy for exercise will also be collected by clinical assessment and questionnaires before and after the behaviour change intervention.
Free-living activity behaviour data will be collected using an accelerometer at various time-points during the intervention and these data will be used to estimate energy expenditure and daily and weekly activity patterns.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105414 0
Dr Rebecca Meiring
Address 105414 0
Room 907-228
Building 907 Department of Exercise Sciences
University of Auckland
End of Suiter Street, Newmarket
Auckland 1023
Country 105414 0
New Zealand
Phone 105414 0
+64 99234815
Fax 105414 0
Email 105414 0
rebecca.meiring@auckland.ac.nz
Contact person for public queries
Name 105415 0
Dr Rebecca Meiring
Address 105415 0
Room 907-228
Building 907 Department of Exercise Sciences
University of Auckland
End of Suiter Street, Newmarket
Auckland 1023
Country 105415 0
New Zealand
Phone 105415 0
+64 99234815
Fax 105415 0
Email 105415 0
rebecca.meiring@auckland.ac.nz
Contact person for scientific queries
Name 105416 0
Dr Rebecca Meiring
Address 105416 0
Room 907-228
Building 907 Department of Exercise Sciences
University of Auckland
End of Suiter Street, Newmarket
Auckland 1023
Country 105416 0
New Zealand
Phone 105416 0
+64 99234815
Fax 105416 0
Email 105416 0
rebecca.meiring@auckland.ac.nz

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 collected de-identified participant data
When will data be available (start and end dates)?
Beginning 3 months and ending 6 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Email address: rebecca.meiring@auckland.ac.nz)


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.