None listed
Conditions
Brief summary
This pilot, feasibility randomised controlled trial (RCT) will recruit 42 people with knee osteoarthritis who have completed the GLA:D® Australia program. Consenting participants will be randomised to an additional intervention to promote physical activity (motivational interviewing and web-based support), or usual care (continuation of exercises and self-management learnt in GLA:D®). Objectives: The primary objective is to determine the feasibility (eligibility and recruitment rates; adherence to motivational interviewing sessions, drop-out rate, credibility of the intervention) of conducting a fully powered trial to evaluate the clinical effectiveness (i.e. increasing physical activity) of using SUpported Motivational InTerviewing (SUMIT) targeting physical activity following completion of a widespread exercise-therapy program (GLA:D®) in people with knee osteoarthritis. Secondary objectives include: • To determine if a worthwhile treatment effect could be observed for physical activity, physical endurance, joint-related quality of life (QoL), health-related QoL and pain. • To refine SUMIT through qualitative feedback from participants.
Interventions
Participants allocated to the SUMIT group will receive five physiotherapist led motivational interviewing sessions (30-40-minutes) over 12 weeks to facilitate behaviour change towards increasing physical activity. Each session will be provided via Zoom or phone call depending on patient preference. Participants can undertake the intervention at home or any place with internet access. Participants will be required to book in a time slot with the intervention physiotherapist (CI-Bell) in weeks 1,2
Participants allocated to the SUMIT group will receive five physiotherapist led motivational interviewing sessions (30-40-minutes) over 12 weeks to facilitate behaviour change towards increasing physical activity. Each session will be provided via Zoom or phone call depending on patient preference. Participants can undertake the intervention at home or any place with internet access. Participants will be required to book in a time slot with the intervention physiotherapist (CI-Bell) in weeks 1,2,4,7,10. The content of each session will refer to the recommended processes of Engagement, Focusing, Evoking and Planning. Participants will have individualised sessions, tailored to their needs at the time of each session. Topics that may arise in MI sessions may include (but are not limited to): personal barriers and enablers to physical activity, and strategies to navigate these; reflections about personal change; and managing pain. Additional education and behaviour change support related to increasing physical activity will be provided via access to a custom designed multimedia website (education resources and goal setting tools) which contains multimedia resources to promote physical activity. The website was created specifically for the SUMIT trial with feedback from physiotherapists, a psychologist and consumers. The website can only be accessed if you have the link to maintain true control subjects during the trial. Use of this website will be at the participant's discretion, however website traffic can be measured. Participants will be referred to the website during MI sessions and asked if they have used the website. Participants will not be given a formal exercise plan, but rather be encouraged to reflect about which activities would motivate them to be more active and how those activities will fit into their lifestyle. If asked, the treating physiotherapist (CI-Bell) can give advice to tune existing programs or where to seek advice as she is a registered physiotherapist. Attendance to MI sessions will be recorded and used to measure feasibility of a fully scale randomised controlled trial. Participants will be supplied with an accelerometer (ActivPAL) one week before baseline and follow up assessments.
Sponsors
Miss Emily Bell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Diagnosis of knee osteoarthritis for participation in GLA:D® is performed by a trained physiotherapist and guided by the NICE guidelines, that is: i) Aged > 45 years ii) Activity-related knee pain iii) Morning stiffness of the knee which lasts less than 30 minutes or no knee stiffness • Have completed GLA:D® in the past 24 months at time of recruitment
Exclusion criteria
• Comorbidity that would prevent participants from increasing physical activity levels as assessed by the Exercise and Sports Science Australia (ESSA) adult pre-screening tool e.g. unstable angina. Participants who do not pass the pre-screening tool will require approval from their general practitioner to participate in this trial (Nb: participants will have passed this screening to participate in GLA:D® in the previous 24-months). • Non-English speaking (would not be able to complete questionnaires or participate in motivational interviewing sessions). • People who have undergone lower limb surgery or back surgery over the past 12 months will be excluded from this trial.
Outcome results
None listed