Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001674426
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
5/12/2016
Date last updated
5/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bodyweight neuromuscular training and lower limbs injuries in female basketball players
Scientific title
Bodyweight neuromuscular training for the reduction of lower limb injuries in elite female basketball players. A randomized controlled trial
Secondary ID [1] 290549 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb injuries 300991 0
Postural Stability 300994 0
Condition category
Condition code
Injuries and Accidents 300788 300788 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 300789 300789 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The bodyweight neuromuscular warm-up protocol will be developed from theory and findings from previous injury prevention research. None of the subjects have had prior exposure to neuromuscular or specific dynamic balance training, which may have interfered with the validity of the testing protocol.

Sessions will take place 4 times a week, during the basketball regular season (32 weeks), before every training session during the warm-up immediately before regular basketball training.

Each 30-minute session will comprise circuit training consisting of bodyweight neuromuscular exercises divided in:
1. General activation with the ball (e.g. jog line to line, shuttle run, lateral and backward running);
2. Mobility exercises (e.g. leg swing front-to-back side to side, lateral squats, lunge superior reach, walking quad stretch, monster walk, inverted hamstring stretch, lateral crossover step); 3. Strength exercises (e.g. multidirectional lunges, nordic hamstrings, single toe raises, lateral bridge);
4. Plyometric exercises (e.g. vertical jumps, lateral hops, single legger hops, forward hops); 5. agility exercises with the ball (fore way close-out, line drills and sprint, zigzag cones, four cones, pass-sprint and layup).

The exercises will be progressed through three different phases using periodization methods. Initially, low volume high-intensity exercises will be performed until the technique will be mastered. The volume will be then increase when the exercise will be executed correctly according to the coach’s judgment. Each athlete self regulated the intensity of exercises to be at RPE CR10 to be between 3 and 5 (moderate - strong). The exercises will progress from a stable to an unstable position to increase demands on lower extremity strength (e.g. split squat, Bulgarian split squat, Bulgarian split squat and jump).

A certified strength and conditioning coach will conduct the sessions and will give verbal and visual feedback on exercise technique.
Intervention code [1] 296413 0
Prevention
Comparator / control treatment
The control treatment will consist of a conventional warm-up, which will consist of light aerobic exercises, basketball and team drills, and dynamic stretching of the major muscle groups before the regular practice sessions.
Control group
Active

Outcomes
Primary outcome [1] 300205 0
Number of lower limb injuries occurred during the regular season.

The medical staff will assess and report each injury according to the criteria of the Federation Internationale de Basketball (FIBA) and the criteria proposed by Junge et al. (2008) [Junge A, Engebretsen L, Alonso JM, et al. Injury surveillance in multi-sport events: the International Olympic Committee approach. Br J Sports Med].

The type, location, and severity of injuries will be entered into a specifically designed database that was checked weekly by the researchers and the medical staff. Individual player participation in training and matches will also be recorded. In addition, we will receive a monthly standard injury report form from the medical staff. Recorded injuries included any event that will result in a player being unable to train fully or to play matches. A player will be considered injured until the team medical staff allowed return to full training and declared the player available for match selection.
Timepoint [1] 300205 0
At the end of basketball regular season.
Secondary outcome [1] 329344 0
Lower limb stability assessed by Y-balance test.

The Y-Balance Test (YBT) will be carried out using a standardized testing protocol that has been shown to be reliable [Plisky PJ, Rauh MJ, Kaminski TW, et al. Star Excursion Balance Test as a predictor of lower extremity injury in high school basketball players. J Orthop Sports Phys Ther. 2009;36:911-919; Plisky PJ, Gorman PP, Butler RJ, et al. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009;4:92-99.]
Timepoint [1] 329344 0
At baseline and after the end of basketball regular season
Secondary outcome [2] 329345 0
Lower limb strength assessed by Counter Movement Jump (CMJ)

The procedures were carried out as described by Maulder and Cronin [Maulder P, Cronin J. Horizontal and vertical assessment: reliability, symmetry, discriminative and predictive ability. Phys Ther Sport. 2005;6:74-82] in which three CMJ with both legs during the push-off phase, were performed on an Optojump Next (Microgate, Bolzano, Italy).
Timepoint [2] 329345 0
At baseline and after the end of basketball regular season

Eligibility
Key inclusion criteria
Aged 18-35 years old, playing at the national level, and practice 4 times a week for more than 2 hours.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of lower extremity injury or surgery in the 6 months prior to testing..

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2015
Date of last participant enrolment
Anticipated
Actual
31/10/2015
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
184
Accrual to date
Final
160
Recruitment outside Australia
Country [1] 8392 0
Italy
State/province [1] 8392 0
Milano

Funding & Sponsors
Funding source category [1] 294978 0
University
Name [1] 294978 0
Universita degli Studi di Milano
Country [1] 294978 0
Italy
Primary sponsor type
University
Name
Universita degli Studi di Milano
Address
Department of Biomedical Sciences for Health, Via Giuseppe Colombo 71, 20133 Milano, Italy
Country
Italy
Secondary sponsor category [1] 293799 0
None
Name [1] 293799 0
Address [1] 293799 0
Country [1] 293799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296335 0
Institutional Ethics Review Committee of the Universita degli Studi di Milano
Ethics committee address [1] 296335 0
Ethics committee country [1] 296335 0
Italy
Date submitted for ethics approval [1] 296335 0
22/09/2015
Approval date [1] 296335 0
12/10/2015
Ethics approval number [1] 296335 0
54/15

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

Contacts
Principal investigator
Name 70502 0
Dr Matteo Bonato
Address 70502 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano,
Via Giuseppe Colombo 71, 20133 Milano
Country 70502 0
Italy
Phone 70502 0
+39,02,5031 4658
Fax 70502 0
Email 70502 0
[email protected]
Contact person for public queries
Name 70503 0
Matteo Bonato
Address 70503 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano,
Via Giuseppe Colombo 71, 20133 Milano
Country 70503 0
Italy
Phone 70503 0
+39,02,5031 4658
Fax 70503 0
Email 70503 0
[email protected]
Contact person for scientific queries
Name 70504 0
Matteo Bonato
Address 70504 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano,
Via Giuseppe Colombo 71, 20133 Milano
Country 70504 0
Italy
Phone 70504 0
+39,02,5031 4658
Fax 70504 0
Email 70504 0
[email protected]

No information has been provided regarding IPD availability


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.