Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000493246
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
4/04/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise-therapy following anterior cruciate ligament reconstruction: a pilot randomised clinical trial
Scientific title
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
Secondary ID [1] 292995 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SUPER KOALA (SUpervisied Patient Education and Rehabilitation for individuals at high risk of Knee OsteoArthritis after anterior cruciate Ligament reconstruction in Australia)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 304907 0
Knee osteoarthritis 307206 0
Condition category
Condition code
Musculoskeletal 304236 304236 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304237 304237 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299235 0
Rehabilitation
Comparator / control treatment
Reflecting current standard care, the CONTROL group will be a minimal intervention CONTROL group and receive a "best practice guide" booklet and one face-to-face appointment with an experienced physiotherapist to explain elements of the booklet and answer any questions. CONTROL group participants may also contact the physiotherapist by phone on one occasion to ask questions/get further clarification. The booklet was produced specifically for this research project, and is based on the information to patients provided by 10 high volume orthopaedic surgeons. The booklet has details of exercises and advice currently provided by the surgeons and thus, truly reflects usual care.

Participants in the CONTROL group will also be required to keep a "log book" to measure compliance of their home exercise program. In addition to compliance, use of medications, other treatments, and symptoms will be monitored.
Control group
Active

Outcomes
Primary outcome [1] 303521 0
Knee-related burden, assessed with the KOOS4, which is the average score of 4 of the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales covering pain, symptoms, difficulty in sports and recreational activities and quality of life.
Timepoint [1] 303521 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session).
Secondary outcome [1] 339164 0
Feasibility of conducting a full-scale RCT will be assessed by a composite of:
- rate of recruitment, determined by the number of participating individuals divided by the total eligible based on surgeon records
- adherence, assessed by log books, including subjective rating of adherence from 0=never performed my exercises to 10=always performed my exercises
- drop-out rate, determined by the number of participants randomised compared to the number of participants with final follow-up data
- occurrence of adverse events, such as pain flares, musculoskeletal soreness, determined by log books
- patient satisfaction with treatment, assessed on a 5 point Likert scale (0=very unsatisfied, to 4=very satisfied)
- attainment of patient goals, determined by whether or not met goals listed at baseline
- use of home exercise equipment and/or gym, assessed in log book
Timepoint [1] 339164 0
12-weeks post-treatment commencement
Secondary outcome [2] 339165 0
Structural worsening
Knee MRIs will be obtained with a 3T scanner. Cartilage defects will be scored with the MRI Osteoarthritis Knee Score (MOAKS). Cartilage defect worsening will be defined as increase in the percentage of full-thickness cartilage loss; incident cartilage loss; or increase in size of any cartilage loss when there is no change in the percentage of full-thickness cartilage loss. Early-stage degeneration in cartilage collagen content and orientation in extracellular matrices will be defined by quantitative changes in T2 relaxation times.
Timepoint [2] 339165 0
Baseline (prior to first intervention session) will be compared to 9 months post-baseline
Secondary outcome [3] 339166 0
Perceived global change score
Participants will rate their perceived change following treatment on a 5-point ordinal scale (much improved, improved, no change, worse and much worse.
Timepoint [3] 339166 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [4] 339167 0
Physical activity assessed with the Tegner Activity Scale
Timepoint [4] 339167 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [5] 339168 0
Knee confidence and psychological readiness to return to sport assessdd with the Anterior cruciate ligament return to sport after injury scale (ACL-RSI)
Timepoint [5] 339168 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [6] 339169 0
Fear of movement assessed with the Tampa Scale for Kinesiophobia
Timepoint [6] 339169 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [7] 339170 0
Presence and severity of anterior knee pain assessed with the Anterior Knee Pain Scale (AKPS)
Timepoint [7] 339170 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [8] 339171 0
Sefl-efficacy assessed with the Self-efficacy of knee function scale
Timepoint [8] 339171 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [9] 339172 0
Knee-related quality of life assessed with the ACL-QOL
Timepoint [9] 339172 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [10] 339173 0
Health-related quality of life assessed with the EuroQoL-5D
Timepoint [10] 339173 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [11] 339174 0
Achievement of acceptable symptoms assessed with the Patient acceptable symptom state (PASS)
Timepoint [11] 339174 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [12] 339175 0
Swelling, as measured by the blinded assessor using the stroke test.
Timepoint [12] 339175 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [13] 339176 0
Global lower limb strength and endurance assessed with the One leg rise test
Timepoint [13] 339176 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [14] 339177 0
Lower-limb function assessed with the Hop for distance, reported in cm each limb
Timepoint [14] 339177 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [15] 339178 0
Strength of quadriceps - seated knee extension with hand held dynamometer at 30°.
Timepoint [15] 339178 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [16] 339179 0
Assessment of movement quality (good, fair, poor based on functional alignment criteria) using single leg squat (SLS) and single leg drop jump (SLDJ).
Timepoint [16] 339179 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [17] 339182 0
Hip abduction (side-lying) muscle strength - assessed by hand held dynamometry
Timepoint [17] 339182 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [18] 339183 0
Strength of hamstrings assessed by hand held dynamometry prone, at 90° flexion.
Timepoint [18] 339183 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [19] 339184 0
Lower-limb function assessed with the Triple crossover hop for distance, reported in cm each limb
Timepoint [19] 339184 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [20] 339185 0
Lower-limb lateral function assessed with the Side hop test, number on each limb.
Timepoint [20] 339185 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [21] 344856 0
Hip external and internal rotation (prone) muscle strength assessed by hand held dynamometry
Timepoint [21] 344856 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)
Secondary outcome [22] 344857 0
Hip extension muscle strength (prone) assessed by hand held dynamometry:
Timepoint [22] 344857 0
Baseline (prior to first intervention session) will be compared to 12 weeks (following last intervention session)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation schedule will be generated and maintained centrally by Latrobe University via central computer randomisation (to either Group A (intervention) or Group B (control)), and will be revealed via telephone by the project coordinator, to the treating physiotherapist following baseline assessment. Participants will be informed that they will be randomized to one of two treatments, but will not be informed of the other treatment nor our hypotheses. As patients may be recruited at staggered time points, the computer randomisation will be set up so that there is a random sequence of "A" or "B" that will result in 16 "A" and 16 "B" by the end point of recruitment. Treating physiotherapists will not know of the features of the alternative treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in ratio 1:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine effect sizes, the primary KOOS4 outcome measured at 12 weeks will be analysed using linear mixed regression models, including the baseline score as a covariate, subjects as a random effect, treatment condition as a fixed-factor and the covariate by treatment interaction. Participant characteristics (e.g. sex, age) will be included as covariates. Secondary outcomes assessing feasibility will include recruitment rate, compliance with all aspects of intervention, drop-out rate and any adverse events. We aim to detect the minimum clinically important improvement on the self-reported outcomes as published by Singh et al (2014). The effect sizes (mean and SD) of the targeted physiotherapy intervention for each of the secondary clinical outcome measures will also be calculated. These will be used for the sample size calculations for a future large-scale RCT. All analyses will be conducted in a blinded manner, on an intention-to-treat basis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sufficient feasibility data collected. Further pilot data from this pilot RCT no longer required as earlier than anticipated awarding of research funding to progress to full-scale RCT occurred.
Date of first participant enrolment
Anticipated
1/05/2018
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
10/10/2018
Date of last data collection
Anticipated
10/07/2019
Actual
Sample size
Target
32
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297620 0
University
Name [1] 297620 0
La Trobe University
Country [1] 297620 0
Australia
Primary sponsor type
Individual
Name
Professor Kay Crossley
Address
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country
Australia
Secondary sponsor category [1] 296636 0
Individual
Name [1] 296636 0
Dr Adam Culvenor
Address [1] 296636 0
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country [1] 296636 0
Australia
Secondary sponsor category [2] 296637 0
Individual
Name [2] 296637 0
Dr Christian Barton
Address [2] 296637 0
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country [2] 296637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298710 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 298710 0
Ethics committee country [1] 298710 0
Australia
Date submitted for ethics approval [1] 298710 0
Approval date [1] 298710 0
21/03/2018
Ethics approval number [1] 298710 0
HEC17-100

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77978 0
Prof Kay Crossley
Address 77978 0
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country 77978 0
Australia
Phone 77978 0
+61394793902
Fax 77978 0
Email 77978 0
[email protected]
Contact person for public queries
Name 77979 0
Christian Barton
Address 77979 0
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country 77979 0
Australia
Phone 77979 0
+61394793902
Fax 77979 0
Email 77979 0
[email protected]
Contact person for scientific queries
Name 77980 0
Kay Crossley
Address 77980 0
La Trobe University
Kingsbury Drive,
Bundoora 3086, VIC
Country 77980 0
Australia
Phone 77980 0
+61394793902
Fax 77980 0
Email 77980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data available on request.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.