None listed
Conditions
Brief summary
Despite profound health and disease-specific benefits of physical activity, 9 of 10 people with knee osteoarthritis (OA) are inactive. Here we aim to assess the effect of two types of education programs added to an individualised, physiotherapist-led walking and strengthening program to determine if it can improve overall health. Cost-effectiveness of the treatments will be undertaken, as will mediation analyses to consider the mechanistic underpinnings of the treatments. Using a parallel-group, multicentre randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 4 weekly in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (and weekly check-in by physiotherapist via phone/telehealth), with follow-up sessions at 3 months (via phone/telehealth) and 5 and 9 months (in-person sessions). Primary outcomes are physical activity level (step count via wrist-based accelerometry) and knee symptoms (WOMAC Total score) at 12 months.
Interventions
Description of interventions/exposure:
The two groups will have consistent graded walking and strengthening components, but a contrasting education component.
Intervention A:
Participants will attend four, 60-90 minute, in-person sessions with a physiotherapist at weekly intervals (over 4 weeks), during which they will receive Education A, a graded walking program and strengthening exercises. All in-person sessions will take place at the private physiotherapy clinic where the trial physiothera
Description of interventions/exposure: The two groups will have consistent graded walking and strengthening components, but a contrasting education component. Intervention A: Participants will attend four, 60-90 minute, in-person sessions with a physiotherapist at weekly intervals (over 4 weeks), during which they will receive Education A, a graded walking program and strengthening exercises. All in-person sessions will take place at the private physiotherapy clinic where the trial physiotherapist is employed. The in-person sessions will be followed by 4 weeks of at home activities (workbook and walking/strengthening progression) with weekly telephone calls or telehealth sessions by the Physiotherapist (20 mins each). A follow-up telephone call/telehealth sessions at 3 months (20 mins) and follow-up in-person sessions with the Physiotherapist (45-60mins) at 5 and 9 months will occur. All treatment components, including choice of telephone/telehealth for home sessions, will be individualised to the participant. To protect trial blinding, the nature of the treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made publically available at the conclusion of the trial. The trial intervention will be provided by physiotherapists with a minimum of 5 years clinical experience. Intervention adherence: This will be assessed via review of attendance records for in-person physiotherapy appointments, via review of participant workbook, walking, and strengthening diaries, and through adherence rating scales completed by participants. Intervention fidelity: A random sample of treatment sessions (minimum of one for each therapist) will be audio recorded to allow audit of intervention fidelity for each group. Each physiotherapist (and physiotherapist clinic) will only provide one of the study interventions. Therapists’ case notes for each session, recorded via standardised templates, will also be used to evaluate intervention fidelity (e.g., ensure other treatments not given).
Sponsors
The University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) Aged greater than or equal to 50 years ii) Average knee pain intensity of at least 4/10 (overall and/or while walking) over past week using a 0-10 numerical rating scale, where 0 = no pain at all and 10 = worst pain possible iii) Moderate disability due to the knee over the past week (greater than or equal to 3 on the Global Disability Rating Scale) iv) Painful knee OA at least 6 months duration that meets the NICE diagnostic criteria for symptomatic knee OA
Exclusion criteria
i) Conditions that prevent safe participation in physical activity as listed in the American College of Sports Medicine guidelines (e.g., cardiac or lung disease) ii) Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain) iii) Neurological disorders affecting lower limb movement (e.g., multiple sclerosis, stroke) iv) Inflammatory arthritis (including rheumatoid arthritis) v) Fibromyalgia vi) Previous knee replacement (on painful knee) or planned knee replacement/surgery (next 6 months) or recent knee replacement on the non- or less-painful knee (<6 months) vii) Previously operated knee is the most painful knee viii) Intra-articular therapy use in the 12 weeks preceding enrolment ix) Any condition impacting decision-making/memory (e.g., Alzheimer’s, dementia) x) Severe depression (>17 on the 4-item PROMIS depression subscale) xi) Current moderate/vigorous physical activity levels above guideline recommendations (>150 minutes/week; assessed using the Active Australia Physical Activity Questionnaire) xii) Current purposeful walking for exercise of 30 mins or more per day on 5 or more days per week. xiii) Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
Outcome results
None listed