ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001164987

Ethics application status

Approved

Date submitted

14/07/2020

Date registered

6/11/2020

Date last updated

1/12/2023

Date data sharing statement initially provided

6/11/2020

Date results information initially provided

1/12/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

A supervised exercise and education rehabilitation program for patients following anterior cruciate ligament reconstruction: SUPER KNEE randomised controlled trial.

Scientific title

The SUPER KNEE trial: comparing the effectiveness of a SUpervised exercise therapy and Patient Education Rehabilitation (SUPER) program vs. minimal intervention on pain, function and early osteoarthritis after anterior cruciate ligament reconstruction

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

SUPER KNEE (SUpervised exercise-therapy and Patient Education Rehabilitation)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anterior cruciate ligament reconstruction

Post-traumatic osteoarthritis

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Participants randomised to the CONTROL intervention will receive a “best-practice guide” booklet and a face-to-face appointment (at baseline assessment) with a registered physiotherapist (not involved in treating SUPER participants). The physiotherapist will explain elements of the booklet and answer any questions. The booklet was produced based on the information provided to patients by orthopaedic surgeons participating in this trial, together with exercise prescription guidelines and best-available evidence for exercises and education following anterior cruciate ligament (ACL) reconstruction. Examples of exercises to strengthen specific lower-limb and trunk muscles, and methods to safely progress these are included, as well as education regarding monitoring and managing symptoms and safe return to sport.

Participants randomised to the CONTROL intervention may also contact the physiotherapist by phone to ask questions/get further clarification. The physiotherapist cannot volunteer information extending the scope of the booklet.

Control group

Active

Outcomes

Primary outcome [1]

KOOS4; 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]

Change from baseline to 4 months post-baseline

Secondary outcome [1]

KOOS4: 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]

Change from baseline to 12 months post-baseline

Secondary outcome [2]

Worsening of cartilage quality on magnetic resonance imaging (MRI)

Timepoint [2]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [3]

Fear of movement: Tampa Scale for Kinesiophobia

Timepoint [3]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [4]

Global rating of change (GROC) on a seven point Likert scale (from much worse to much better).

Timepoint [4]

4 and 12 months post-baseline

Secondary outcome [5]

Participant perception of achievement of acceptable symptoms: Patient acceptable symptom state (PASS)

Timepoint [5]

4 and 12 months

Secondary outcome [6]

Health and Labour Questionnaire

Timepoint [6]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [7]

Work Limitations Questionnaire

Timepoint [7]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [8]

Euro Qol 5D (EQ-5D)

Timepoint [8]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [9]

Global lower-limb muscle strength: One leg rise functional test

Timepoint [9]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [10]

Lower-limb functional performance assessed with the hop for distance test

Timepoint [10]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [11]

Peak isometric torque of knee extension and flexion muscle strength using isokinetic dynamometer

Timepoint [11]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [12]

Assessment of movement quality: Asymmetry of single/double leg squat, drop jump, and repeated hopping .
The asymmetry of these movements will be assessed via force plates and video rated by experienced clinician researchers.

Timepoint [12]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [13]

Whole knee joint morphology assessed with the MRI osteoarthritis knee score (MOAKS)

Timepoint [13]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [14]

Cost-effectiveness of SUPER intervention derived from cost per Quality Adjusted Life Year (QALY) derived from EQ-5D assessments

Timepoint [14]

18-month time horizon

Secondary outcome [15]

Average steps per day assessed with physical activity watch

Timepoint [15]

4 and 12 months post-baseline

Secondary outcome [16]

Physical Activity: Tegner Activity Scale

Timepoint [16]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [17]

Current and worst knee pain during previous 7 days (0-100 visual analogue scale)

Timepoint [17]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [18]

ACL-Quality of Life Questionnaire

Timepoint [18]

Change in baseline to 4 and 12 months post-baseline

Secondary outcome [19]

Early osteoarthritis clinical markers (knee effusion, crepitus, joint line tenderness) assessed via a physical examination by a blinded researcher

Timepoint [19]

4 and 12 months post-baseline

Secondary outcome [20]

KOOS-pain

Timepoint [20]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [21]

KOOS-symptoms

Timepoint [21]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [22]

KOOS-activities of daily living

Timepoint [22]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [23]

KOOS-Sport and Recreation

Timepoint [23]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [24]

KOOS-Quality of life

Timepoint [24]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [25]

Lower-limb functional performance assessed with the side hop test

Timepoint [25]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [26]

Lower-limb functional performance assessed with the triple crossover hop for distance test

Timepoint [26]

Change from baseline to 4 and 12 months post-baseline

Secondary outcome [27]

Body mass assessed with electronic floor scales

Timepoint [27]

Change assessed from baseline to 4 and 12 months

Secondary outcome [28]

Waist girth assessed with tape measure around the umbilicus

Timepoint [28]

Change assessed from baseline to 4 and 12 months

Secondary outcome [29]

Bone shape assessed from magnetic resonance imaging of the femur, tibia and patella

Timepoint [29]

Change assessed from baseline to 4 and 12 months

Secondary outcome [30]

Active knee flexion range of motion assessed with a goniometer in supine

Timepoint [30]

Change assessed from baseline to 4 and 12 months

Secondary outcome [31]

Passive knee extension range of motion assessed as a heel height difference in prone

Timepoint [31]

Change assessed from baseline to 4 and 12 months

Secondary outcome [32]

Rate of torque development of knee extension and flexion muscles using isokinetic dynamometer

Timepoint [32]

Change assessed from baseline to 4 and 12 months

Secondary outcome [33]

Vertical hop test assessing maximum hop height

Timepoint [33]

Change assessed from baseline to 4 and 12 months

Eligibility

Key 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

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

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)

Participants will be randomised to either the SUPER Intervention or CONTROL Intervention. Randomisation schedule will be generated by a secure randomisation service established independently to the research team (concealed allocation). The randomisation schedule for each participant will be maintained centrally by La Trobe University (REDCap) and revealed to an unblinded member of the research team who will communicate treatment allocation to the participant.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Include random permuted blocks of 4-8, so that an allocation ratio of 1:1 will be maintained at periodic intervals.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

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

For the primary hypothesis, generalised linear models (with baseline value as a covariate and treatment condition and referral source [public vs private] as fixed factors) will be used to evaluate the treatment effect on KOOS4 at 4 months (p<0.05). A generalised linear model utilising repeated measures at all time-points (for 12-month secondary hypotheses) will allow non-biased estimates of treatment effect in the presence of any potential missing cases, providing data are missing at random. However, a sensitivity analysis to missing data will also be carried out using multiple imputation to ensure there are no unexpected biases. This approach also permits adjustment for differences between groups in potential confounders at baseline (age, sex, BMI, duration between injury and surgery).

For secondary binomial outcomes (e.g. cartilage defect worsening assessed with the MOAKS), mixed-effect logistic regression models will be used to assess the effect of treatment. Treatment will be included as a fixed factor and covariates will also be included to adjust for potential confounding factors. Estimates of association will be presented as unstandardized regression coefficients and risk ratios, together with 95% CIs.

All randomised participants will be included in the intention to treat analysis and in the safety analysis. Per protocol and as treated analyses will be performed for primary and secondary outcomes by a statistician blinded to group allocation.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

23/11/2020

Actual

26/02/2021

Date of last participant enrolment

Anticipated

Actual

20/04/2023

Date of last data collection

Anticipated

22/04/2024

Actual

Sample size

Target

184

Accrual to date

Final

184

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/11/2019

Ethics approval number [1]

HREC 537/19

Ethics committee name [2]

La Trobe University Human Research Ethics Committee

Ethics committee address [2]

Kingsbury Drive, Bundoora, Victoria 3086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

25/11/2019

Ethics approval number [2]

HEC19447

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kay Crossley

Address

Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia

Country

Australia

Phone

+61 3 9479 3902

Fax

[email protected]

Contact person for public queries

Name

Dr Adam Culvenor

Address

Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia

Country

Australia

Phone

+61 3 9479 5116

Fax

[email protected]

Contact person for scientific queries

Name

Dr Adam Culvenor

Address

Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia

Country

Australia

Phone

+61 3 9479 5116

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We have not planned to share individual participant data at this stage.

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

Source	Title	Year of Publication	DOI
Embase	SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER) versus minimal intervention for young adults at risk of knee osteoarthritis after ACL reconstruction: SUPER-Knee randomised controlled trial protocol.	2023	https://dx.doi.org/10.1136/bmjopen-2022-068279

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically