Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002036291
Ethics application status
Approved
Date submitted
4/12/2018
Date registered
19/12/2018
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Copenhagen exercise and Nordic hamstring exercise on improving functional balance among athletes
Scientific title
Effect of Copenhagen exercise and Nordic hamstring exercise on improving functional balance among male athletes; a randomized controlled trial.
Secondary ID [1] 296782 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance 310677 0
Groin/Hamstring injuries 310679 0
Condition category
Condition code
Musculoskeletal 309377 309377 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effects of the Copenhagen exercise (CE) and Nordic hamstring exercise (NHE) have been evaluated and shown reduce in injury incidence significantly. However, the effects of the CE or NHE protocol on improving functional balance have not been investigated and yet may be important. Therefore, we will evaluate the effect of CE and NHE on improving functional balance compare to no intervention, among amateur male athletes.
Methods: male amateur athletes aged 19–25 years will be randomly assigned to CE and NHE intervention groups (n=20 athletes), CE intervention group (n= 20 athletes), NHE intervention groups (n= 20 athletes) or a control group (n= 20 athletes).

The Copenhagen Exercise. The CE exercise is a partner exercise in which the player lies on his or her side with one forearm as support on the floor and the other arm placed along the body. The upper leg is held at approximately hip height of the partner, who holdsthe leg with one arm supporting the ankle and the other supporting the knee. The player then raises his or her body from the field and the lower leg is adducted so that the feet touch each other and the body is in a straight line The body is then lowered halfway to the ground while the foot of the lower leg is lowered so that it just touches the floor without being used for support. The exercise is performed on both sides.

The Nordic Hamstring Exercise. The NHE is performed in pairs. Players start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the player’s feet are in contact with the ground throughout the exercise by applying pressure to the player’s heels/lower legs. The player then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phas.

Exercise Prescription for the CE and NHE:
Beginner 3 Training Sessions Per Week 1 Set 3-5 Repetitions
Intermediate 3 Training Sessions Per Week 1Set 7-10 Repetitions
Advanced 3 Training Sessions Per Week 1Set 12-15 Repetitions
Compliance will be evaluated according to the players’ rate of participation using an attendance log.
The total duration of the intervention is 6 weeks.
Intervention administers: Physiotherapist and Senior Physiotherapy students.
Intervention code [1] 313085 0
Prevention
Comparator / control treatment
The control group will practice their usual warm up.
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions. Such as; running, bicycling, jogging, stretching etc..
Control group
Active

Outcomes
Primary outcome [1] 308335 0
All groups will perform the pre- post intervention test using Biodex Balance Stability System . The primary outcome measure will be balance.
Timepoint [1] 308335 0
6 weeks post-enrolment
Secondary outcome [1] 354634 0
Incidence of lower extremity injuries..
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
This data will be collected using Sports Medicine Australia injury reporting form
http://websites.sportstg.com/get_file.cgi?id=2308813
Timepoint [1] 354634 0
Assessed weekly for 6 weeks

Eligibility
Key inclusion criteria
Male athletes
Training at least three times per week.
Minimum age
19 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
G*Power: Statistical Power Analyses for Windows Version 3.1.9.2 was used to calculate the sample size of 80 participants. which will be sufficient for this study,
CE and NHE intervention group (n=20 athletes), CE intervention groups (n=20 athletes), NHE intervention group (n=20 athletes) or a control group (n=20 athletes).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
16/05/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 21095 0
Saudi Arabia
State/province [1] 21095 0

Funding & Sponsors
Funding source category [1] 301358 0
University
Name [1] 301358 0
Umm Al Qura University
Country [1] 301358 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al Qura University
Address
Al Awali, Mecca 24381.
Country
Saudi Arabia
Secondary sponsor category [1] 301029 0
None
Name [1] 301029 0
Address [1] 301029 0
Country [1] 301029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302100 0
Research Ethics Committee, Department of Physical Therapy
Ethics committee address [1] 302100 0
PO Box: 715, Makkah, 21955, Saudi Arabia
Ethics committee country [1] 302100 0
Saudi Arabia
Date submitted for ethics approval [1] 302100 0
02/07/2018
Approval date [1] 302100 0
31/08/2018
Ethics approval number [1] 302100 0
PT2018/01

Summary
Brief summary
Background: The effects of the Copenhagen exercise (CE) and Nordic hamstring exercise (NHE) have been evaluated and shown reduce in injury incidence significantly. However, the effects of the CE or NHE protocol on improving functional balance have not been investigated and yet may be important. Therefore, we will evaluate the effect of CE and NHE on improving functional balance compare to no intervention, among amateur male athletes.
Methods: male amateur athletes aged 19–25 years will be randomly assigned to CE and NHE intervention (n=2 groups, 20 athletes), CE intervention (n=2 groups, 20 athletes), NHE intervention (n=2 groups, 20 athletes) or a control group (n=2 groups, 20 athletes). All groups will perform the pre- post intervention test using Biodex Balance Stability System and functional balance tests. The primary outcome measure will be improving functional balance with factoring of the exposure time.
Conclusion: This cluster randomized controlled trial will provide level I evidence that implementation of CE or NHE can improving functional balance among male athletes, leading to reduce injury risk and decrease of injury related financial burden on the healthcare system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89110 0
A/Prof Wesam Saleh A. Al Attar
Address 89110 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89110 0
Saudi Arabia
Phone 89110 0
+966548206504
Fax 89110 0
Email 89110 0
[email protected]
Contact person for public queries
Name 89111 0
A/Prof Wesam Saleh A. Al Attar
Address 89111 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89111 0
Saudi Arabia
Phone 89111 0
+966548206504
Fax 89111 0
Email 89111 0
[email protected]
Contact person for scientific queries
Name 89112 0
A/Prof Wesam Saleh A. Al Attar
Address 89112 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89112 0
Saudi Arabia
Phone 89112 0
+966548206504
Fax 89112 0
Email 89112 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
No individual participant data will be available


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.