None listed
Conditions
Brief summary
A common but likely erroneous belief is that using exercise as a treatment for knee osteoarthritis will cause damage to an already worn joint. We propose to perform the first RCT to examine the effect walking has on knee structure, objectively assessed using MRI. Participants will be randomised to either community walking plus usual care or usual care alone for 6 months. Participants randomised to walking will walk 3 days/week for one hour (2 days/week supervised group sessions and 1 day/week unsupervised). Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients. The aim of this study is to generate pilot data for a proposed larger study (which aims to enrol a total of 186 participants, funding applications currently under consideration) to demonstrate feasibility of the study design, recruitment, screening, adherence, safety and retention. This pilot study will enrol 48 participants (24 randomised to walking plus usual care and 24 to usual care). It will be conducted in line with the recent CONSORT statement for pilot and feasibility trials.
Interventions
Participants randomised to the intervention group (community walking plus usual care) will be asked to train 3 days per week for 6 months. They will walk 2 days/week in a supervised group session and 1 day/week unsupervised at home. Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients. Trained physiotherapists/exercise physiologists will lead a group of up to 10 participants. The
Participants randomised to the intervention group (community walking plus usual care) will be asked to train 3 days per week for 6 months. They will walk 2 days/week in a supervised group session and 1 day/week unsupervised at home. Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients. Trained physiotherapists/exercise physiologists will lead a group of up to 10 participants. The structure of our walking program is based on a walking protocol published by Ettinger et al in JAMA 1997. Each session (group based or home based) will last 1 hour and consist of: • 10 min warm up consisting of slow walking and arm circles, trunk rotation, shoulder and chest stretches, and side stretch. • 40 min group walking where participants are encouraged to walk at 50–70% of their heart rate reserve. This frequency and intensity is currently recommended for Australian adults and for adults with knee OA. • 10 min cool down. The cool-down will consist of slow walking and 3 flexibility exercises: a shoulder stretch, hamstring stretch, and lower back stretch. Using the validated Rating of Perceived Exertion Scale (RPE), physiotherapists/exercise physiologists will instruct and motivate participants to walk at a moderate intensity, defined as intensity to raise heart rate to a point where you sweat and are working somewhat hard (13-15 RPE - equivalent to 50-70% of heart rate reserve). The walking classes will occur at locations around Hobart that offer a loop track or an out and back course, to allow participants to walk at their own intensity. Also, at the start of the intervention each physiotherapist/exercise physiologist will have a volunteer from our research team with them to help familiarise participants with the intervention and the courses. Strategies to maintain adherence: We have researchers on the team who are trained in behavioural methods to enhance adoption and maintenance of exercise (both from a research and clinical perspective). Our program will provide social support, positive reinforcement, goal setting, rewards for attendance, frequent contact, recognition in study update newsletters, and participants will receive a Fitbit in recognition of their commitment, time and effort. The participants will report all training sessions in training diaries. The physiotherapists/exercise physiologists and an unblinded research officer specifically employed to implement the intervention will monitor compliance. Together they will identify any participants who need additional reminders and/or counselling. If a participant misses a group-based session, they will receive a phone call to discuss their study goals and barriers to participation. All physiotherapists/exercise physiologists employed to work on the project will be required to complete a ‘train-the-trainers’ 1/2-day workshop to ensure the program is consistently administered and compliance is consistently monitored. Participants in this group will also receive the same care provided to the usual care group (see below for details).
Sponsors
Menzies Institute for Medical Research, University of Tasmania
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Males and females aged 45 or over; 2) Have clinically diagnosed knee OA (according to the American College of Rheumatology criteria); 3) Have had symptomatic knee OA for at least 6 months with a pain visual analogue scale (VAS) score of at least 40mm/100mm over the last 7 days; 4) Have a bone marrow lesion (BML) present on MRI (prevalence 88% at screening in our recent clinical trial). 5) Have no difficulty in walking a city block (75-100 metres). 6) Be willing to participate in a walking program for 6 months, and can attend on days/times of the week that scheduled walking classes are running.
Exclusion criteria
1) Severe knee pain (on standing greater than 80mm/100mm on VAS); 2) Participation in any form of exercise at a moderate/vigorous level for >150 min/week or walking >10,000 steps/day – will be assessed for 7 consecutive days during screening using Actigraph accelerometers (meta-analysis data demonstrates that few knee OA sufferers meet these levels of activity (13% and 19% respectively)); 3) Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance; see below for the procedure for this); 4) Other forms of arthritis in which disease is active and concomitant medication is used (e.g., rheumatoid arthritis); 5) Participants who have undergone significant trauma to the ‘study’ knee in the previous 12 months (injury, arthroscopy or open surgery); 6) Receiving intra-articular therapy (e.g. corticosteroids, hyaluronic acid) in the study knee in the last 6 months; 7) Anticipated need for knee or hip surgery within the next 6 months; 8) Contra-indication to MRI (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for scanner); 9) Plan to commence exercise or another new treatment for knee OA in the next 6 months. 10) Use of a gait aid. 11) Inability to give informed consent.
Outcome results
None listed