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Exercise-therapy following anterior cruciate ligament reconstruction: a pilot randomised clinical trial

The efficacy of exercise-therapy on knee-related burden for individuals at high risk of knee osteoarthritis following anterior cruciate ligament reconstruction: a pilot randomised clinical trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000493246
Acronym
SUPER KOALA (SUpervisied Patient Education and Rehabilitation for individuals at high risk of Knee O
Enrollment
8
Registered
2018-04-04
Start date
2018-06-04
Completion date
2018-10-10
Last updated
2020-03-03

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

Conditions

None listed

Brief summary

Knee osteoarthritis is a national health priority, and commonly occurs in young adults following anterior cruciate ligament reconstruction (ACLR) – creating a scenario of ‘young people with old knees’. Having an ACL injury combined with a meniscectomy and/or chondral lesion is associated with more pain and worse quality of life after ACLR, and best identifies those at risk of future knee osteoarthritis, low physical activity participation, and worse symptoms and quality of life in the long term. Considering the profound impact of a combined injury after ACLR on young adults, effective interventions targeting functional restoration are urgently needed. Our prior data indicates <30% of people received or completed physiotherapy beyond 6 months post ACLR, which may assist in restoring normal physical function after ACLR. Appropriately supervised and progressed exercise-therapy and patient education that targets individual needs has potential to reduce the burden of impaired function post-ACLR (i.e. young people with old knees). This study aims to investigate the efficacy and feasibility of a randomised controlled trial to improve function, symptoms and quality of life in people with an ACL injury combined with a meniscectomy and/or chondral lesion 6-15 months after ACLR. The study will compare the effects of a Supervised Patient Education Rehabilitation program, targeted to individual needs, (SUPER), to a minimal intervention CONTROL program, where a best practice guide booklet and one face-to-face physiotherapy appointment is provided.

Interventions

Individuals 6-15 months post-ACLR will be randomised to the SUpervisied Patient Education and Rehabilitation (SUPER) group or CONTROL group. The SUPER group will complete 1 x face-to-face physiotherapy session (duration 30 minutes) and 1 x small group session (duration 60 minutes) per week for 12 weeks with an experienced musculoskeletal or sports physiotherapist. These will occur following a baseline assessment session with a research assistant. Physiotherapy in this pilot RCT will have a dis

Individuals 6-15 months post-ACLR will be randomised to the SUpervisied Patient Education and Rehabilitation (SUPER) group or CONTROL group. The SUPER group will complete 1 x face-to-face physiotherapy session (duration 30 minutes) and 1 x small group session (duration 60 minutes) per week for 12 weeks with an experienced musculoskeletal or sports physiotherapist. These will occur following a baseline assessment session with a research assistant. Physiotherapy in this pilot RCT will have a distinct focus on functional retraining split into “progressive phases”. These phases are similar to a neuromuscular retraining intervention that has led to clinically meaningful changes in self-reported functional and quality of life outcomes in knee injury populations (articular cartilage lesions) with ongoing functional deficits following a similar period of rehabilitation. There are 8 main "tasks" or exercises: 1. Quadriceps strength 2. Hip extension strength (hamstrings and gluteals) 3. Balance 4. Movement retraining (jumping, landing and cutting strategies) 5. Calf strength 6. Trunk strength 7. Hip abduction strength 8. Sport-specific/cardiovascular Each task will have progressive phases within it. For example, “Quadriceps strength” will start at phase one of a bilateral isometric wall sit, then once the pass criteria is met (60sec hold at 90 degrees knee flexion, nil pain or response in the knee), they move to a double leg squat with increasing weights, then to an assisted and unassisted single-leg squat with increasing weights, then to a weighted squat jump power exercise. The 8th task of "sport specific/cardiovascular exercise," is also phased. For example, participants may not have begun running, so phase 1 starts at walking/bike/swimming, then once they have passed the criteria (range of strength, control and balance tests) they may move to running. The SUPER exercise-therapy program targets the strength and functional impairments typically seen post-ACLR, and will be matched to each patient’s preferences, goals, clinical presentation (e.g. strength, pain severity, personal, sporting, work and functional needs), presence of comorbidities (e.g. other musculoskeletal pain) and progressed based on response to exercise. Strengthening exercises will utilise strength training principles (e.g. ~70-80% 1 repetition maximum; 3-4 sets x 8-10 reps), supplemented with neuromuscular exercises and plyometrics. The physiotherapist will supervise and progress exercises from the 8 key tasks, each with 3-5 phases of increasing difficulty, based on strengthening principles criteria, and provide feedback during each visit. Self-managed additional exercise sessions will be encouraged 2 x week. These home exercise sessions will be approximately 30-45 minutes depending on the level of the patient. The PhysiTrack® and PhysiApp® app, a web-application compatible with smartphones, tablets and computers, and designed for physiotherapists and patients, will provide photos, videos and instructions of exercises to be played out in real time. 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. Specific topics include understanding of the increased osteoarthritis risk after knee injury and its pathology and progression, benefits of physical activity, optimising strength and importance of SUPER program, fear avoidance and criteria for a graduated return to activities with patient-specific goal setting. Participants will also be encouraged to enhance their physical activity using a targeted, graduated cardiovascular retraining program adhering to World Health Organisation and Australian Physical Activity Guideline. Participants will be required to keep a "log book" to measure compliance of their home exercise program via the PhysiApp® on their smart device/computer. They will also have the option of paper version if not able to use the app. In addition to compliance, use of medications, other treatments, and symptoms will be monitored. Physiotherapists will also mark attendance at each of the physiotherapy sessions. They will also perform standardised assessment (balance, strength, function) at each physiotherapy session, which may improve adherence. This will be recorded by the physiotherapists in a log book. Participants will be asked to refrain from other physiotherapy/rehabilitation interventions but stable drug doses will be permitted. To minimise participant burden, study physiotherapists will be located at clinics across greater Melbourne. Treating physiotherapists will undergo a 4-hour training session provided by the research team, with treatment manuals that have been designed by the researchers with input from experienced clinicians, and fidelty checks via auditing of treatment notes. Our initiatives to optimise standardisation include examples of exercise videos, frequently asked questions, and being available to address queries promptly via phone/e-mail. The treating physiotherapists will record per protocol treatment and any co-interventions in a log book.

Sponsors

Professor Kay Crossley
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

(i) aged 18-40 years at time of ACLR; (ii) arthroscopic ACLR with a hamstring-tendon or bone-patellar tendon-bone autograft 6-15 months prior; (iii) meniscal tear treated with meniscectomy, or chondral lesion identified at time of surgery; (iv) poor self-reported function (i.e., KOOS4 score <85)

Exclusion criteria

(i) subsequent injury (for which medical treatment was sought) or follow-up surgery to the ACLR knee; (ii) actively seeing physiotherapist for ongoing ACLR rehabilitation (ie. appointment in past 6 weeks); (iii) intraarticular knee injection in the past 3 months; (iv) pregnancy; (v) another condition affecting physical function; (vi) inability to understand English language; (vii) unable to commit to 12-weeks exercise program

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026