Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001724268
Ethics application status
Approved
Date submitted
10/10/2018
Date registered
18/10/2018
Date last updated
1/03/2022
Date data sharing statement initially provided
1/03/2022
Date results information initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Strength trainning in water polo players: diferences between hypertrophy and power trainning.
Scientific title
Strength workout in water polo players: gender and age-related diferences in isokinetic strength and sport performance
Secondary ID [1] 296286 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sport medicine 310075 0
shoulder injuries 310076 0
Condition category
Condition code
Musculoskeletal 308734 308734 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sample will be divide into two groups according to the type of training performed during the intervention: maximal strength group (MG) and power strength group (PG).
Players of each group will complete 24 sessions of training during 12 weeks. Each session is divided in 10 min of stretching and warm up, 45 min of workout and 5 min of return to rest. Both group will develop the training sessions in the gym of the water polo club, as they do usually. All of the players are familiarized with the exercises. The training session for the MG will base on weight lifting mainly, while for the PG will base on exercise balls weight bearing exercises. In order to calculate the appropriate weight, each player´s maximum repetition will be assessed before the training. All the training sessions will be supervised by their training coach.
The adherence to the intervention will be assessed recording the assistance. Players will be also requested about wellness following the “Total Quality Recovery” questionnaire (McLean et al., 2010).
Intervention code [1] 312616 0
Diagnosis / Prognosis
Intervention code [2] 312617 0
Early detection / Screening
Intervention code [3] 312618 0
Prevention
Comparator / control treatment
Maximal strength training is the most common training method and the methodology based on power strength is the novelty of this study. Due to this fact, MG will be comparator group.
Control group
Active

Outcomes
Primary outcome [1] 307723 0
Isokinetic strength (N/m).

Prior to the isokinetic tests, the participants will perform a standardized heating using an ergonomics of arms, and a machine with pulleys and resistance directed by means of compressed air, whose characteristics are:
A) Ergonometer:
· Duration 3'
· Force: 25 N
· Intensity: 8.6 / 40 repetitions per minute
B) Machine with pulleys and resistance directed by means of compressed air:
· Movements: internal rotation, external rotation, internal rotation with 90º abduction, and external rotation with 90º abduction
· Series: 3
· Repetitions: 15
· Execution:
Scapular plane: we place the pulley in a straight line to the body.
Plane in abduction: we place the pulley as high and low as possible, that is, at the ends of the machine itself.

The isokinetic muscle test consists of two tests performed lying on the isokinetic machine face up with the shoulder joint in a position of 90 degrees in the dominant arm both extremities. The corresponding tests are:
· Internal Rotation (IR) in Concentric (CC) / External Rotation (ER) in Concentric (CC). Speed: 60º.
· Internal Rotation in Concentric / External Rotation in Concentric. Speed: 240º.
· Features:
Speed: 60º - 240º
Series: 2 (first adaptation)
Repetitions: 5
Rest: 20” between the test series and the main one; 1’ between tests.
Timepoint [1] 307723 0
Timepoints: baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [1] 352645 0
“Total Quality Recovery” questionnaire (McLean et al., 2010).
Timepoint [1] 352645 0
Each sesion during 12 weeks.
Secondary outcome [2] 353039 0
Anthropometric measurements:
· Weight, height, seated height, wingspan, leg length, Body Mass Index (BMI) and the Reciprocal Ponderal Index (RPI). The necessary material is a scale, height meter and tape measure.
· Cutaneous folds: subscapular, triceps, biceps, iliac crest, supra-spinal, abdominal, frontal thigh and triceps surae. The necessary material is a caliper.
· Diameters: elbow, wrist, knee and ankle. The necessary material is a caliber.
· Perimeters: relaxed arm, arm in flexion and tension, waist, hip, thigh and triceps surae. The necessary material is a tape measure.
· With the collected data will be calculated: bone, fat and muscle percentages.
Timepoint [2] 353039 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [3] 353040 0
Manual Grip Strength Test
Timepoint [3] 353040 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [4] 353041 0
Bench press test to measure the strength of the upper train.

Material:
- Bank with support.
- Bodybuilding bar.
- Discs of different weights.

Heating:
Exercise Bench press
• Series: 1
• Repetitions: 10
• Intensity: 40-60% 1RM

Test:
Features:
a. Series: 5 (in ascending progression)
b. Reps: Maximum
c. Rest: 2’ between series
Timepoint [4] 353041 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [5] 353042 0
Vertical jump test (CMJ) to measure the strength of the lower train.

Material:
- Optojump next.

Heating:
Exercise CMJ
• Series: 2
• Repetitions: 1
• Rest: 1’ between series

Test:
Features:
a. Series: 2
b. Reps: 1
c. Rest: 2’ between series
Timepoint [5] 353042 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [6] 353043 0
Throw test, to measure the throw speed.

Material:
- Radar Stalker-Sport-Radar (Plano, TX, USA).
- Chronometer.

Heating:
1. Free swimming: 10'
2. Free passes: 5'

Test:
Features:
a. Maximum speed
b. Distance: 5 meters
c. Series: 3
d. Repetitions: 3
e. Rest: 15” between throws; 1’ between series
Timepoint [6] 353043 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [7] 353044 0
Swim time test in 20 meters distance.

Material:
- Chronometer.

Heating:
1. Free swimming: 10'

Test:
Features:
a. Maximum speed
b. Distance: 20 meters
c. Series: 3
d. Rest: 3’ between series
Timepoint [7] 353044 0
Baseline during the week before starting the intervention and final assessment 12 weeks later.
Secondary outcome [8] 353045 0
Measurement of the daily training load, through the training minutes x Borg Scale.
Timepoint [8] 353045 0
Each sesion during 12 weeks.

Eligibility
Key inclusion criteria
All participants will be adequately informed, participating voluntarily and providing a signed consent form. In the case of minors participants, the consent will be signed by their parents and / or legal guardians. All of the participants will belong to the Leioa Water Polo Club, which is register in the Royal Spanish Federation of Swimming.
Minimum age
14 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As mentioned Michener (2004) at the time of carrying out the study protocol, a series of exclusion criteria are established. These are: patients with surgical history in shoulder and / or traumatic shoulder injury; cervicalgia, cervicobrachialgia or paresis of the upper extremity; have undergone previous rehabilitation treatment; and passive limitation of the joint range of the affected shoulder.

Michener, L, Walsworth, M, and Burnet, E. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. Hand Ther 17: 152-164, 2004.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will be performed using IBM SPSS Statistics software (v 22.0).
We´ll analyze the normality of the data by the Kolmogorov-Smirnov test. In case of break of the normality, logarithmic transformations will made. The level of significance will be established at p < 0.05. The threshold values for the statistics to assess the effect will be 0.1, 0.2, 0.5 and 0.8 for the trivial effect sizes, small, medium and large, respectively (Cohen, 1992). The differences between workout, and between categories will be analyzed using the Student's T test (parametric variable) or Mann-Whitney U test (nonparametric variable), and T test for related samples.

Cohen, J. A power primer. Psychol Bull, 112: 155, 1992.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2018
Actual
15/11/2018
Date of last participant enrolment
Anticipated
15/11/2018
Actual
15/11/2018
Date of last data collection
Anticipated
17/02/2019
Actual
18/02/2019
Sample size
Target
50
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 20908 0
Spain
State/province [1] 20908 0
Bizkaia

Funding & Sponsors
Funding source category [1] 300877 0
University
Name [1] 300877 0
University of the Basque Country (UPV/EHU)
Country [1] 300877 0
Spain
Primary sponsor type
University
Name
University of the Basque Country (UPV/EHU)
Address
Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Basque Country, Spain
Country
Spain
Secondary sponsor category [1] 300441 0
None
Name [1] 300441 0
Address [1] 300441 0
Country [1] 300441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301652 0
Ethics Committee of the UPV / EHU: CEISH
Ethics committee address [1] 301652 0
Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Basque Country, Spain
Ethics committee country [1] 301652 0
Spain
Date submitted for ethics approval [1] 301652 0
17/12/2015
Approval date [1] 301652 0
14/03/2016
Ethics approval number [1] 301652 0
M10_2015_290_TORRES UNDA

Summary
Brief summary
The purposes of this research project are the following:
• Determine the most effective strength training system to improve the physiological performance of water polo players, women and men.
• Determine the least painful and most effective strength training system to maintain compensation of internal and external rotation in the glenohumeral joint of water polo players, women and men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87666 0
Mr Josu Barrenetxea-García
Address 87666 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Basque Country.
Country 87666 0
Spain
Phone 87666 0
00-34-94 601 29 58
Fax 87666 0
Email 87666 0
[email protected]
Contact person for public queries
Name 87667 0
Mr Josu Barrenetxea-García
Address 87667 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Basque Country.
Country 87667 0
Spain
Phone 87667 0
00-34-94 601 29 58
Fax 87667 0
Email 87667 0
[email protected]
Contact person for scientific queries
Name 87668 0
Mr Josu Barrenetxea-García
Address 87668 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n, E-48940, Leioa, Bizkaia, Basque Country.
Country 87668 0
Spain
Phone 87668 0
00-34-94 601 29 58
Fax 87668 0
Email 87668 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


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.