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Trial registered on ANZCTR


Registration number
ACTRN12623000818639
Ethics application status
Approved
Date submitted
11/07/2023
Date registered
31/07/2023
Date last updated
31/07/2023
Date data sharing statement initially provided
31/07/2023
Date results provided
31/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Foam roller use effects on eccentric strength of the knee flexors for rugby sevens players.
Scientific title
Acute application of foam rollers effects on eccentric knee flexor strength and range of motion for rugby sevens players
Secondary ID [1] 310082 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal injury 330633 0
Condition category
Condition code
Musculoskeletal 327460 327460 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants completed two testing sessions that lasted for approximately 30 minutes.
There was a 1-week washout between testing sessions within the cross-over design.
A researcher supervised all exercises and testing for correct application and compliance to the protocol.
Participants used a grid foam roller (FR) cylinder (height:13inches,diameter:5.5inches; TriggerPoint, USA). On the FR day, after the initial eccentric knee flexor test, active straight leg raise test (ASLR), and active knee extension test (AKE) were completed, the athletes began the FR intervention. These exercises were performed for thirty seconds with ten-second rest intervals for three sets, bilaterally on the gastrocnemius and hamstring muscles. During the application, the metronome was set to 40 beats per minute. Thus, the participants were advised to apply an application rate of ten rolls per 30 seconds while targeting the area with maximum tolerable pressure.
Gastrocnemius: The athlete sat on the exercise mat with the FR underneath their leg. They placed the FR in the mid-point between the knee and ankle joints. They used their hands to support themselves on the sides and lifted their hips. They slowly rolled the FR towards the center of the ankle and returned to the starting point. The breathing and tempo of the exercise were verbally instructed by the researcher.
Hamstring: The athlete sat on an exercise mat with the FR immediately underneath the thigh. They placed the FR in the center of the hip and knee joint. They raised their hips from the ground using their hands on the sides. They slowly rolled the FR towards the top of the knee joint and returned to the starting point. The breathing and tempo of the exercise were verbally instructed by the researcher.
One minute after the exercises were completed, the ASLR and AKE were performed on the dominant and non-dominant extremities and their values were recorded. After one minute of rest, the athletes performed the eccentric knee flexor test for one set of three maximum repetitions. The maximum and average torque values and imbalance values were recorded after the test.
Intervention code [1] 326482 0
Treatment: Other
Comparator / control treatment
No treatment: resting quietly on a mat with no stimulation for an equivalent period to the intervention (approximately 30 minutes total duration).
Control group
Active

Outcomes
Primary outcome [1] 335320 0
Eccentric knee flexor strength was assessed using Nord board - Maximal Eccentric strength (N).
Timepoint [1] 335320 0
Immediately pre-treatment and immediately post-treatment for the intervention and control conditions.
Primary outcome [2] 335394 0
Eccentric knee flexor strength was assessed using Nord board and averaged across the test - Average Eccentric strength (N).
Timepoint [2] 335394 0
Immediately pre-treatment and immediately post-treatment for the intervention and control conditions.
Secondary outcome [1] 423945 0
Hip range of motion assessed by Active Straight Leg Raise test
Timepoint [1] 423945 0
Immediately pre-treatment and immediately post-treatment for the intervention and control conditions.
Secondary outcome [2] 424344 0
Knee range of motion assessed by active Knee Extension test.
Timepoint [2] 424344 0
Immediately pre-treatment and immediately post-treatment for the intervention and control conditions.

Eligibility
Key inclusion criteria
Male athletes aged 18 years and over playing rugby sevens for a Turkish University team. The criteria for the athletes to be included in this study were: well trained, no lower extremity injury in the past 6 months, having performed regular strength exercises in the past 3 months, having at least 2 years of athletic history, not using dietary or physiological ergogenic substances.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants were excluded if they had epilepsy, diabetes, neurological disorders, lower extremity disability, open wound, surgical lower extremity disability, or any other health issue that could prevent them from participating in the study protocols. Athletes were instructed not to engage in strenuous physical activity 24 hours prior to the test session and not to consume foods or drinks containing caffeine or similar stimulants for the same period.

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)
No concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis was conducted using SPSS 26.0 (SPSS, Inc., Chicago, IL, USA). Descriptive statistics including mean and standard deviation were given for numerical variables in the tables and individual responses were shown graphically. Normality of numerical variables was evaluated using the Shapiro-Wilk test. All variables were had a normal distribution (p>0.05). Within group change was assessed using a paired T-test. Comparison of the measurements was examined using Mixed Variance Analysis (2x2 mixed ANOVA) to determine if the pre-test and post-test (time) measurements in the acute FR and NFR protocols differed based on group and time. In cases of significant difference, pairwise comparisons were analyzed with the Bonferroni test. To demonstrate the power of the statistical analysis, effect size values using Eta squared were utilized to indicate the proportion of variance in the dependent variable explained by a specific independent variable). Chi-squared values less than 0.25, between 0.26 and 0.63, and greater than 0.63 was classified as small, medium, and large effect sizes, respectively, and p<0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2021
Date of last participant enrolment
Anticipated
Actual
29/05/2021
Date of last data collection
Anticipated
Actual
9/06/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 25629 0
Turkey
State/province [1] 25629 0

Funding & Sponsors
Funding source category [1] 314246 0
University
Name [1] 314246 0
Trakya University Faculty of Medicine
Country [1] 314246 0
Turkey
Primary sponsor type
Individual
Name
Daniel van den Hoek
Address
University of the Sunshine Coast, 1 Moreton Pde, Petrie, QLD, Australia, 4502
Country
Australia
Secondary sponsor category [1] 316181 0
None
Name [1] 316181 0
None
Address [1] 316181 0
None
Country [1] 316181 0
Other collaborator category [1] 282746 0
Individual
Name [1] 282746 0
Christopher Latella
Address [1] 282746 0
Edith Cowan University, 270 Joondalup Dr, Joondalup WA 6027
Country [1] 282746 0
Australia
Other collaborator category [2] 282747 0
Individual
Name [2] 282747 0
Isa Sagiroglu
Address [2] 282747 0
Trakya University, Sükrüpasa, Bülent Ecevit Cd. 22 C, 22030 Iskender/Edirne Merkez/Edirne, Türkiye
Country [2] 282747 0
Turkey
Other collaborator category [3] 282748 0
Individual
Name [3] 282748 0
Haili Ibrahim Ceylan
Address [3] 282748 0
Üniversite, Atatürk Üniversitesi Kampüsü, 25030 Yakutiye, Türkiye
Country [3] 282748 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313364 0
Ethical Committee for Scientific Research of Trakya University Faculty of Medicine
Ethics committee address [1] 313364 0
Ethics committee country [1] 313364 0
Turkey
Date submitted for ethics approval [1] 313364 0
Approval date [1] 313364 0
06/11/2019
Ethics approval number [1] 313364 0
18/20

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

Contacts
Principal investigator
Name 127894 0
Dr Daniel van den Hoek
Address 127894 0
University of the Sunshine Coast, 1 moreton Pde, Petrie, QLD, Autralia, 4502
Country 127894 0
Australia
Phone 127894 0
+61 7 5459 4643
Fax 127894 0
Email 127894 0
dvandenhoek@usc.edu.au
Contact person for public queries
Name 127895 0
Daniel van den Hoek
Address 127895 0
University of the Sunshine Coast, 1 moreton Pde, Petrie, QLD, Autralia, 4502
Country 127895 0
Australia
Phone 127895 0
+61 7 5459 4643
Fax 127895 0
Email 127895 0
dvandenhoek@usc.edu.au
Contact person for scientific queries
Name 127896 0
Daniel van den Hoek
Address 127896 0
University of the Sunshine Coast, 1 moreton Pde, Petrie, QLD, Autralia, 4502
Country 127896 0
Australia
Phone 127896 0
+61 7 5459 4643
Fax 127896 0
Email 127896 0
dvandenhoek@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval does not include the dissemination of IPD


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 386209-(Uploaded-10-07-2023-10-08-59)-Basic results summary.docx
Plain language summaryNo A total of 20 rugby sevens players (age: 24.16 ± 2... [More Details]

Documents added automatically
No additional documents have been identified.