None listed
Conditions
Brief summary
In young people (<40 years), arthritis commonly occurs following knee reconstruction, forcing them to live with old knees and reducing their quality of life. In the SUPER KNEE trial we aim to evaluate whether supervised exercise and education can improve knee symptoms, function and quality of life and prevent joint deterioration compared to usual care in 184 young adults with knee reconstruction. We hypothesis that individuals in the supervised exercise and education intervention will have significantly less pain, greater quality of life and less early arthritis after 4 and 12 months compared to the usual care control group.
Interventions
The SUPER intervention is divided into two phases. Phase 1 (0-4 months): all participants randomised to the SUPER intervention, will complete exercise-therapy 2-3 x per week. This will be made up of 1-2 x weekly supervised sessions and 1-2 x weekly unsupervised sessions at a gym or home, depending on individual preference (total 2-3 weekly sessions). Supervised physiotherapy-led sessions (either small group [maximum 6 participants] or 1:1) and unsupervised sessions will be 30-60 minutes duration. Phase 2 intervention (4-12 months): Intervention provided will depend on whether predefined criteria are met at the 4-month follow-up assessment (ie. participant's goals are met, participant satisfied with current symptoms/function and global rating of change reported as at least improved). For participants meeting all criteria, Phase 2 will involve ongoing unsupervised exercise-therapy sessions (30-60 minutes duration, 3 x per week at a gym or home). Monitoring of symptoms and exercise-therapy adherence will occur every 2 months, facilitated by a phone call from an unblinded researcher. Physiotherapy booster sessions will be triggered if the predefined criteria are no longer met (ie. participant's goals are met, participant satisfied with current symptoms/function and global rating of change reported as at least improved). Participants may also request a booster session if they become unsure about continuation of self-management or exercise-therapy. Booster sessions can continue once per week and will focus on the priority exercises and discussion of self-management strategies. If all criteria are not met at the end of Phase 1 (4-months post-baseline), Phase 2 will involve ongoing once per week supervised exercise-therapy. Once all criteria are met, participants will continue exercise-therapy sessions at a gym or home with physiotherapy booster sessions as required (as per above criteria). Additional functional reassessment session with the treating physios will occur at 11 months post-baseline. The specific exercises and education intervention will be tailored to each participant to match their individual preferences, goals and clinical presentation (e.g. strength, pain severity, personal, sporting, work and functional needs). The three key components (lower-limb and trunk muscle strength; movement quality; and sport- or activity-specific retraining) have levels of increasing difficulty. The physiotherapist will supervise and progress exercises based on defined criteria (perceived difficulty using rating of perceived exertion, minimal pain (e.g. <3/10 on numerical pain scale)), and provide feedback during each visit. Strengthening exercises will utilise American College of Sports Medicine strength training principles (e.g. rating of perceived exertion at least 7/10, 3 sets of 8-12 reps, and periodisation involving one lighter week per month of 5/10 exertion), supplemented with neuromuscular and plyometric exercises. Equipment (e.g. resistance bands and/or weights) will be provided for participants to be able to complete exercises at home. All SUPER participants will be prescribed 5 PRIORITY exercises targeting: i) weight-bearing quadriceps strength (eg. single leg squats with weights); ii) open chain knee extension strength; iii) hamstring strength (eg. bridges and Nordic curls); iv) balance/agility (eg. bosu ball single leg stance); and v) plyometrics (eg. hopping). Participants will also be encouraged to complete an additional 4 exercises to target trunk, hip and calf strength. The total number of exercises prescribed (maximum number of 9) will depend on the participant time availability, willingness and clinical reasoning – but will always include the 5 PRIORITY exercises. Individualised health education regarding expectations and goals, improving adherence, long-term outcomes, weight control, and appropriate physical, occupational and sporting activity promotion, will be delivered during the physiotherapy treatment sessions. Two dedicated education sessions of 30-60 minutes duration will be delivered during Phase 1 (week 1 and week 4). SUPER education has been specifically developed for this project and will be delivered face-to-face, with supplementary web- and paper-based material (e.g. booklet, online videos). Education topics and guidelines will be provided to the physiotherapists at the training sessions and in the treatment manual. Participants will be counselled regarding physical activity levels with a targeted training program adhering to Australian Physical Activity Guidelines and given an activity monitor (e.g. Garmin watch) to support measurement and obtainment of physical activity goals. Participants will complete a logbook of completed supervised/unsupervised exercises. They will be contacted via phone at 2 monthly intervals to further monitor and encourage adherence, with the option of a second opinion by a member of our clinical expert physiotherapy team if the SUPER treatment is failing to facilitate improvement (either at 2- or 4-months post-baseline), or adherence is low. Second opinion will provide assessment and guidance on patient education and exercise therapy needs. All participants in the SUPER intervention will be provided with a membership to a local gym to encourage unsupervised exercise-therapy adherence during Phase 2. At monthly intervals during Phase 1, physiotherapists will perform functional assessments in the clinic (hop tests, one leg rise) to provide feedback to participants, to help motivate participants and allow the physiotherapist to tailor and progress exercises.
Sponsors
Study design
Eligibility
Inclusion criteria
(i) Aged 18-40 years at the time of ACLR; (ii) 9-36 months following ACLR; (iii) KOOS4 score <80/100; (iv) willing/able to complete exercise-therapy 3 times per week for at least 4 months
Exclusion criteria
(i) synthetic ACLR graft; (ii) concomitant intra-articular knee fracture; (iii) planning to relocate interstate/internationally in following 12 months or unable to commit to the various study assessments over the next 12 months; (iv) knee re-injury/surgery in past 3 months (either knee); (v) intra-articular knee injection in past 3 months (either knee); (vi) participation in physiotherapy in past 6 weeks (for conditions affecting either knee); (vii) other health condition affecting physical function; (viii) contraindications to MRI; (ix) pregnancy; (x) inability to understand English; (xi) planning knee surgery in following 12 months.