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Benefits of education and exercise for knee osteoarthritis

Effects of self-directed versus supervised exercise program combined with digitally supported patient education for knee osteoarthritis: a mixed method feasibility study with a randomised controlled trial design

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000123640
Enrollment
24
Registered
2023-02-07
Start date
2023-03-06
Completion date
2023-07-30
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot feasibility randomised controlled trial will recruit 24 people with knee osteoarthritis. Consenting participants will be randomised to either a self-directed exercise-therapy (n=16) or supervised exercise-therapy (n=8). Both groups will receive a digitally support patient education through the ‘My Knee’ tool kit. The primary aim of this study is to determine the feasibility of conducting a fully powered randomised controlled trial to compare self-directed to supervised exercise-therapy for people with knee osteoarthritis. Secondary aims include: • To compare outcomes between groups, 12 weeks following treatment commencement, related to average pain, physical function, joint- and health-quality of life, exercise and physical activity participation, self-efficacy with exercise and osteoarthritis management, outcome expectations for exercise, people’s beliefs about management treatment, determinants of exercise behaviour, global rating of change and treatment satisfaction; • To explore barriers and enablers to intervention effectiveness, potential intervention and study design improvements, and other factors that might influence the participant’s adherence.

Interventions

All participants will receive a digitally supported patient education intervention, and will be supported to perform exercise-therapy. Digitally supported patient education A Physiotherapist will provide two online 60-minutes education sessions, facilitated on Zoom, to all participants prior to randomisation to exercise therapy delivery mode. During these sessions, participants will be provided a power point presentation covering education topics and content, with the opportunity to ask questio

All participants will receive a digitally supported patient education intervention, and will be supported to perform exercise-therapy. Digitally supported patient education A Physiotherapist will provide two online 60-minutes education sessions, facilitated on Zoom, to all participants prior to randomisation to exercise therapy delivery mode. During these sessions, participants will be provided a power point presentation covering education topics and content, with the opportunity to ask questions. They will be shown how to access specific pages and use resources of the ‘My Knee’ education and self-management toolkit (www.myknee.trekeducation.org ) related to each topic, and provided the opportunity to ask questions about how to use the resources if they are unsure. Particular emphasis and time will be spent on the self-directed exercise-therapy resources. In session 1, the topics ‘understanding osteoarthritis’, including information about osteoarthritis and its symptoms, and ‘understanding treatments’, including information about three lines of treatment will be covered. In session 2, further education about topics covered in session 1 will be provided, along with discussion of supports and processes to engage in exercise-therapy in a self-directed fashion. The two education sessions will be provided in the first two weeks (once a week) after the baseline assessment. The adherence to the education sessions will be monitored by the physiotherapist as one of the feasibility outcomes. Exercise-therapy Both self-directed and supervised (online or in-person) exercise groups will be encouraged to complete at least 12 60-minute exercise-therapy sessions (twice a week – over at least 6 weeks to complete the 12 sessions), and ideally complete an exercise program 3-4 times per week during the intervention period. The exercise-therapy program will be based on the neuromuscular exercise program [1] (www.nemex.trekeducation.org ). Each exercise-therapy session will consist of three parts: a warm-up (10 minutes of any cardiovascular exercise), a set of standardised but individualised exercises, and a cool down (walking and stretching). Exercises include sliders which are progressed to lunges, functional movements (step ups and chair stands), knee strength in sitting (flexion and extension), hip strength in standing (adduction and abduction), and trunk strength in supine with the aid of a gym ball (sit ups and pelvic lifts). Each exercise is progressed within and between levels with the goal of avoiding pain flares (<2/10 increase) during or following (return to day-to-day symptoms within 24 hours) exercise sessions, and participants finding the exercises at least moderately difficult based on the Borg rate of perceived exertion scale (ranging from 6 to 20) [2]. Guidance to facilitate these principles will be provided to all participants during the two online education sessions. Further details of the exercise program, including video instructions to support both groups in this study can be found at ‘My Knee’ toolkit. The program is designed to require minimal equipment (chair, step, resistance bands, light weights, gym ball), and able to be completed easily at home. All necessary equipment will be provided by the researchers to all participants enrolled in this trial. The individualisation of the exercise-therapy program will occur through assessment of performance of exercises from the NEMEX program during the second education session. At that moment, a physiotherapist will provide recommendations on what level to start each NEMEX exercise component at to all participants - i.e. exercise difficulty will be individualised. Exercises will then be progressed or regressed based on guidance from the toolkit resources and/or physiotherapist providing supervision (if applicable). Regardless of allocation, all participants will receive an electronic custom diary to monitor their adherence to exercise-therapy. Participants of both groups will be encouraged, during the entire study, to continue to use the ‘My Knee’ education and self-management toolkit to help answer questions they may have and reinforce strategies for active self-management. Self-directed exercise group (n=16): Participants allocated to self-directed exercise group will be provided with an electronic version of a printable exercise guide and asked to perform the exercise-therapy sessions without supervision. 1. Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010;11:126. doi:10.1186/1471-2474-11-126 2. Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-58. doi:10.5271/sjweh.1815

Sponsors

Christian Barton
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of knee osteoarthritis guided by the NICE guidelines1: i) age > 45 years; ii) Activity-related knee pain; iii) No morning knee joint stiffness or knee joint stiffness that lasts less than 30 minutes. 1. Conaghan PG, Dickson J, Grant RL, Guideline Development Group. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ. 2008;336(7642):502-503. doi:10.1136/bmj.39490.608009.AD

Exclusion criteria

• Any treatment for their knee pain in the previous 6-months; • History of knee replacement, lower limb or back surgery in the past 12 months; • Physical or cognitive impairment that would prevent participation in the exercise program; • Presence of other joint problems with symptoms more pronounced than osteoarthritis, including recent trauma, tumour, inflammatory joint disease; • People who are non-English speaking, self-identified as having low digital literacy (unable to use videoconferencing software)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026