Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000550707
Ethics application status
Approved
Date submitted
27/02/2022
Date registered
8/04/2022
Date last updated
8/07/2022
Date data sharing statement initially provided
8/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of the use of the Foam Roller in the recovery in water polo players.
Scientific title
Effect of the use of the Foam Roller in the recovery in water polo players: gender and age-related differences in sport performance, inflammatory markers, and antioxidant levels
Secondary ID [1] 306545 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sport performance 325435 0
Muscle recovery 325436 0
Condition category
Condition code
Musculoskeletal 322814 322814 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-myofascial release group with Foam Roller (FRG). Players will complete 16 sessions of training during 4 weeks, performing 4 sessions per week. The group will develop the training sessions in the swimming pool of the water polo club, as they usually do. The recovery session will be based on performing a self-myofascial release with a foam roller on the muscles immediately after finishing each training session: gluteus medius, tensor fasciae latae, adductor, lower back, upper back, back of the shoulder and chest ; with a total of 10 minutes. All the training sessions will be supervised by their training coach.
The adherence to the intervention will be assessed by recording the attendance. Players will also be requested about wellness following the “Total Quality Recovery” questionnaire (Kentta & Hassmen, 1998).
Intervention code [1] 322969 0
Treatment: Other
Comparator / control treatment
Control Group (CG). Players will complete 16 sessions of training during 4 weeks, performing 4 sessions per week. The group will develop the training sessions in the swimming pool of the water polo club, as they usually do. After finishing the sessions, the players will perform passive stretching or will not performing any specific recovery exercise. All the training sessions will be supervised by their training coach.
The adherence to the intervention will be assessed by recording the attendance. Players will also be requested about wellness following the “Total Quality Recovery” questionnaire (Kentta & Hassmen, 1998).
Control group
Active

Outcomes
Primary outcome [1] 330602 0
Blood extraction: measurement of interleukin (IL-6) and antioxidants.
Timepoint [1] 330602 0
Baseline during the week before starting the intervention and final assessment 4 weeks later.
Secondary outcome [1] 406913 0
Total Quality Recovery questionnaire, TQR (Kentta & Hassmen, 1998).
Timepoint [1] 406913 0
The day after each training session and competition, during the 4-week study period.
Secondary outcome [2] 406914 0
Measurement of the daily training load, through the training minutes x Borg Scale (perception of fatigue), being a composite; by means of a participant self-report diary.
Timepoint [2] 406914 0
At the completion of each session and competition, during the 4-week study period.
Secondary outcome [3] 406915 0
Heart rate assessment, using a pulsometer.
Timepoint [3] 406915 0
Assessed once per day, upon awakening, during the 4-week study period.
Secondary outcome [4] 406917 0
Vertical jump test in the water to measure the strength of the lower extremities of the body. Material: - board with a centimeter scale and a video camera.
Warm-up: Jump exercise • Series: 2 • Repetitions: 1 • Rest: 1 minute between series.
Characteristics of the vertical jump test: • Series: 3 • Repetitions: 1 • Rest: 30 seconds between series.
Timepoint [4] 406917 0
Baseline during the week before starting the intervention and final assessment 4 weeks later.
Secondary outcome [5] 406918 0
Throw test, to measure the throw speed.
Material: - Radar Stalker-Sport-Radar (Plano, TX, USA).
Warm-up: • Free swimming: 10 minutes • Free passes: 5 minutes.
Characteristics of the test: • Maximum speed • Distance: 5 meters • Series: 3 • Repetitions: 3 • Rest: 15 seconds between throws, 1 minute between series.
Timepoint [5] 406918 0
Baseline during the week before starting the intervention and final assessment 4 weeks later.
Secondary outcome [6] 406919 0
Swim time test in 20 meters distance.
Material: - Chronometer.
Warm-up: • Free swimming: 10 minutes.
Characteristics of the test: • Maximum speed • Distance: 20 meters • Series: 3 • Rest: 3 minutes between series.
Timepoint [6] 406919 0
Baseline during the week before starting the intervention and final assessment 4 weeks later.
Secondary outcome [7] 407812 0
Food frequency questionnaire (FFQ).
Timepoint [7] 407812 0
In the third week of the 4-week study period.

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
17 Years
Maximum age
28 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
Treatment
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 treatment, 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
25/04/2022
Actual
25/04/2022
Date of last participant enrolment
Anticipated
27/04/2022
Actual
27/04/2022
Date of last data collection
Anticipated
29/05/2022
Actual
31/05/2022
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 24622 0
Spain
State/province [1] 24622 0
Bizkaia

Funding & Sponsors
Funding source category [1] 310881 0
University
Name [1] 310881 0
University of the Basque Country (UPV/EHU)
Country [1] 310881 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] 312156 0
None
Name [1] 312156 0
Address [1] 312156 0
Country [1] 312156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310441 0
Ethics Committee for Research with Human Beings, Their Samples and Their Data (CEISH) of the University of the Basque Country (UPV / EHU)
Ethics committee address [1] 310441 0
Ethics committee country [1] 310441 0
Spain
Date submitted for ethics approval [1] 310441 0
03/01/2022
Approval date [1] 310441 0
21/03/2022
Ethics approval number [1] 310441 0

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

Contacts
Principal investigator
Name 117678 0
Dr Julio Calleja-Gonzalez
Address 117678 0
University of the Basque Country: Universidad del Pais Vasco; Portal de Lasarte Kalea, 71, 01007, Gasteiz, Araba
Country 117678 0
Spain
Phone 117678 0
+34946417736
Fax 117678 0
Email 117678 0
[email protected]
Contact person for public queries
Name 117679 0
Julio Calleja-Gonzalez
Address 117679 0
University of the Basque Country: Universidad del Pais Vasco; Portal de Lasarte Kalea, 71, 01007, Gasteiz, Araba
Country 117679 0
Spain
Phone 117679 0
+34946417736
Fax 117679 0
Email 117679 0
[email protected]
Contact person for scientific queries
Name 117680 0
Julio Calleja-Gonzalez
Address 117680 0
University of the Basque Country: Universidad del Pais Vasco; Portal de Lasarte Kalea, 71, 01007, Gasteiz, Araba
Country 117680 0
Spain
Phone 117680 0
+34946417736
Fax 117680 0
Email 117680 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.