Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000325707
Ethics application status
Approved
Date submitted
24/06/2021
Date registered
22/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
22/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated versus traditional rehabilitation program after anterior cruciate ligament (ACL) reconstruction in high level athletes
Scientific title
Evaluation of a new integrated rehabilitation program versus a traditional rehabilitation program in the postoperative high-level athletes with anterior cruciate ligament reconstruction
Secondary ID [1] 304618 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 322538 0
Condition category
Condition code
Musculoskeletal 320165 320165 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 320166 320166 0 0
Other physical medicine / rehabilitation
Surgery 320167 320167 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurophysiological and metabolic capacities that underpin sport practiced by each subject, the parameters of frequency, intensity, recovery, etc. with which each neurophysiological and metabolic capacity will be administered to each subject will be calibrated on the basis of the results of the evaluation tests carried out for each neurophysiological and metabolic capacity and modulated in relation to the residual functional capacities of each subject in each specific period of rehabilitation program.

The correct development of an integrated post Anterior Cruciate Ligament Reconstruction (ACL-R) rehabilitation program requires an assessment of the functional requirements imposed by the sport practiced by the athlete who will be rehabilitated, as well as a knowledge of the training principles applied in his/her specific sport. This requires a close collaboration between physician, physiotherapist and athletic trainer. In addition, a periodic re-evaluation of the athlete is necessary during the rehabilitation program in order to acquire the information necessary to manipulate the various variables (load intensity, repetitions, recovery time, etc.) to achieve the desired objectives, always keeping considering what are the functional requirements of the sport practiced. Traditional rehabilitation after an injury still follows predetermined blocks in a fixed timeline, the integrated rehabilitation program followed by group 2 consider both physical (strength and aerobic parameters) and neuromuscular capacities from the early rehabilitation stage; only dosage changes in time. Moreover, in the integrated rehabilitation program neurophysiological parameters of the sport practiced must be taken into consideration.
Generally: integrated rehabilitation program will be divided into two phases: Phase 1 (0-4 months) of supervised rehabilitation sessions of 1 hour, once a day, five times a week, from Monday to Friday, starting 1 week after surgery; and Phase 2 (4-12 months) of sport-specific retraining sessions of 1 hour, four times a week, Monday-Tuesday, Thursday-Friday these sessions will be performed at gym or on field.
On a daily basis it will be monitored:
• Intervention adherence with an attendance checklist and facilitated every month by a face-to-face session with an unblinded physiotherapist.
• Pain assessment test. A visual analog scale (VAS): 0-3 green; 4-5 yellow, and 6-10 red, along with descriptions of pain at each level will be displayed on the interface of each strength equipment and used to track the rate of perceived discomfort during movement and used to assess improvements and managing the overloads progression. The traffic light approach will be used for pain monitoring in both phases. The traffic light has three pain levels on. Feedback on the perception of discomfort in the execution of the exercise will be reported by the patient to the physiotherapist in each session. the goal will be to perform exercises with minimal or no discomfort (light green 0-3 VAS) in both phases; in the second phase an execution with discomfort in yellow light (4-5 VAS) will also be tolerated.

• As soon as the patients will have full range of motion and every week, patients following the integrated rehabilitation protocol will undergo series of tests represented by:
• strength and power evaluation (Isometric Maximal Voluntari Contraction and Rate of Force Development and s
Symmetry) by means of isometric and isotonic test protocol embedded on each equipment for lower limb training (Leg Extension, Leg Curl, Leg Press).
• At the beginning of the rehabilitation phase patients will use a ‘viscus resistance’ in which the resistance increases with movement speed. The patients than will progress through an isotonic resistance as soon as he will be able to execute each movement at maximum speed without any discomfort. The percentages of workloads for maximum strength and power will be determined, already from the first phase, respectively at 80-90% and 35-40% of the maximum reached in the isokinetic test, which will be re-determined weekly.
• aerobic conditioning to evaluate maximal oxygen consumption on a stationary bike. The test result will be based on the linear relationship between oxygen uptake and heart rate increases. Patients will train at increasing percentages of the maximal oxygen uptake. Aerobic workload capacity will be based on maximal power capacity exertion measured in watts on a stationary bike with a graded exercise test (step of 1 minute). In phase 1 patients will train with a load corresponding to 50% of the measured maximal power capacity. If during the rehabilitation process the load will be perceived as too light it will be updated with increments of 5%. At the beginning of phase two patients will execute a new test and the training intensity will be set at 75% of the maximal power capacity exertion
All treatment will be performed at the same rehabilitation center or in field and in both cases under the supervision of qualified physiotherapists, sports specialist personal trainers, and strength and conditioning specialists.
An assessment of the neurophysiological and cardiometabolic parameters will be carried out every two months. The intervention provided will depend on whether the predefined criteria will be met at the follow-up assessment every 2 months (i.e. the participant's goals are met, the participant is satisfied with current symptoms / functions, and the overall assessment of change reported as at least improved).
Intervention code [1] 320967 0
Rehabilitation
Intervention code [2] 322442 0
Treatment: Other
Comparator / control treatment
Group 2. In the traditional rehabilitation program, the first 6 weeks after surgery, rehabilitation goals will be to reduce inflammation and swelling, restore full knee extension, gait training and neuromuscular training to facilitate quadriceps activity. After approximately 6 weeks, neuromuscular training will continue with more advanced drills and muscle strengthening and endurance training will be added. At 12 weeks, muscle hypertrophy strengthening will be start and running activities and jumping tasks will be added. In weeks 24–36, plyometric activities, running/cutting drills, followed by sport-specific agility drills on the field, will be initiated. For the Group 2 strengthening exercises will utilize 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.
Monitoring intervention adherence will occur every day by a session attendance checklists, and facilitated every month by a face-to-face session with an unblinded physiotherapist.

All treatment were performed at the same rehabilitation center or in field and in both cases under the supervision of qualified physiotherapists, sports specialist personal trainers, and strength and conditioning specialists.
Control group
Active

Outcomes
Primary outcome [1] 328048 0
The primary outcome will be a composite of the limb symmetry index (%) of the maximum voluntary isometric force (MVCi) and the rate of force development (RFD) of the lower limbs, measured with the horizontal leg press. The MVIC and the RFD were calculated using a system for muscle performance measurement (MuscleLab 4000; BoscosystemLab SpA, Rieti, Italy). The apparatus was used to set the knee angle during the horizontal leg-press test with an electronic goniometer (BoscosystemLab SpA) and to record the force-time curve with a strain gauge load cell set (ET-STG-02; BoscosystemLab SpA) that collected data at a sampling rate of 100 Hz.
Timepoint [1] 328048 0
before starting rehabilitation programs and 3-6-9-12 (primary endpoint) months post-intervention commencement
Secondary outcome [1] 397336 0
Self-reported knee function assessed using a composite of the International Knee Documentation Committee (IKDC) evaluation system, and the Tegner score
Timepoint [1] 397336 0
before starting rehabilitation programs and 3-6-9-12 months post-intervention commencement
Secondary outcome [2] 397337 0
Short version of Tampa Scale for Kinesiophobia (TSK-11)
Timepoint [2] 397337 0
before starting rehabilitation programs and 3-6-9-12 months post-intervention commencement
Secondary outcome [3] 404194 0
Fatigue index (or measure of the anaerobic endurance)

The subject will run up to a 5 meter mark (then 10 and then 20) and back to the start each time; for a total of 70 meters shuttle run). The time taken to complete each 7o-m shuttle run was recorded.
The Fatigue Index will be derived from six 70-m shuttle runs as follow:

Average time of 6 shuttle runs x (slowest shuttle run- fastest shuttle run) x 6 / shuttle runs completed
Timepoint [3] 404194 0
At 3, 6, 9, and 12 months post-intervention commencement

Eligibility
Key inclusion criteria
High-level athletes that underwent ACL-R
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tibial plate fracture; ACL rupture of the other knee; ACL reconstruction using a ligament augmentation and reconstruction system (LARS),

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
A power analysis (*G*Power, version 3.1.7) was used to calculate the required sample size. With an effect size of 0.30 (medium–large effect ANOVA) and an alpha of 0.05, 20 subjects per groups will be required to obtain a power of 0.80.
A two-sample unpaired t test and chi-square test were applied to compare the differences of continuous and categorical variables, respectively.
A two-way analysis of variance (ANOVA) with group (Integrated versus traditional programs) as the between-subject factor and time last assessment in healthy condition, assessments: before rehabilitation program, and during rehabilitation program at 3-6-9, and 12 months) as the within-subjects factor was used to assess the presence of significant differences between the two groups and within each group. A Tukey post-hoc comparison was used to determine significant differences between mean values when a significant main effect and interaction were found
Statistical analyses were performed using the MedCalc, version 11.1.1.0 for Windows (MedCalc Software, Mariakerke, Belgium) All analyses were performed according to the principle of intention-to-treatment, in which patients with missing data were counted as treatment failures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 23916 0
Italy
State/province [1] 23916 0

Funding & Sponsors
Funding source category [1] 308978 0
University
Name [1] 308978 0
University of L'Aquila
Country [1] 308978 0
Italy
Primary sponsor type
University
Name
University of L'Aquila
Address
Via Giuseppe Petrini - “Rita Levi Montalcini” Building (Delta 6) - 67100 Coppito-L'Aquila
Country
Italy
Secondary sponsor category [1] 309913 0
None
Name [1] 309913 0
N/A
Address [1] 309913 0
N/A
Country [1] 309913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308871 0
Internal Review Board of the University of L'Aquila
Ethics committee address [1] 308871 0
Ethics committee country [1] 308871 0
Italy
Date submitted for ethics approval [1] 308871 0
Approval date [1] 308871 0
27/03/2021
Ethics approval number [1] 308871 0
50/2020-21

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

Contacts
Principal investigator
Name 112170 0
Prof Angelo Cacchio
Address 112170 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112170 0
Italy
Phone 112170 0
+390862434747
Fax 112170 0
Email 112170 0
[email protected]
Contact person for public queries
Name 112171 0
Angelo Cacchio
Address 112171 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112171 0
Italy
Phone 112171 0
+390862434747
Fax 112171 0
Email 112171 0
[email protected]
Contact person for scientific queries
Name 112172 0
Angelo Cacchio
Address 112172 0
Department of Life, Health & Environmental Sciences
University of L'Aquila
“Rita Levi Montalcini” Building (Delta 6) Via Giuseppe Petrini 67100 Coppito-L'Aquila
Country 112172 0
Italy
Phone 112172 0
+390862434747
Fax 112172 0
Email 112172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only deidentified data will be available, including demographic data, outcome measures including strength, and patient reported function and fatigue index, as per the ethics consent process.
When will data be available (start and end dates)?
This data will be available once the trial is completed and the main results have been published, for 10 years
Available to whom?
This will be available to all consented participants, to all involved in the research team, and on a case by case basis at the discretion of the Primary Investigator
Available for what types of analyses?
Statistical analysis to achieve the aims in the proposal, but not aimed at producing similar studies
How or where can data be obtained?
Data can be obtained via the Primary Investigator, Prof. Angelo cacchio ([email protected])


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.