Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002037280
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 Single-Leg Stance and Jumping exercises on improving functional balance among female athletes.
Scientific title
Effect of Single-Leg Stance and Jumping exercises on improving functional balance among female athletes; a randomized controlled trial
Secondary ID [1] 296784 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports related injuries
 310680 0
Condition category
Condition code
Musculoskeletal 309378 309378 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effects of the Single-Leg Stance (SLS) and Jumping exercises (JE) have been evaluated and shown reduce in injury incidence significantly. However, the effects of the SLS or JE on improving functional balance have not been investigated and yet may be important. Therefore, we will evaluate the effect of SLS and JE on improving functional balance compared to no intervention, among amateur female athletes.
Methods: female amateur athletes aged 19–25 years will be randomly assigned to SLS and JE intervention group (n=20 athletes), SLS intervention group (n=20 athletes), JE intervention group (n=20 athletes) or a control group (n= 20 athletes).
SLS+JE intervention group and SLS intervention group will perform:
Single -leg stance hold the ball
This exercise improves leg muscle coordination and balance.
Assume the starting position, standing on one leg and holding the ball in front of you in both hands.
Bend your knee and hip slightly so that your upper body leans forwards slightly. When viewed from the front, the hip, knee and foot of your supporting leg are in a straight line. Hold the raised leg slightly behind the supporting leg.
During this exercise, hold your balance and keep your body weight on the ball of your foot. Hold for 30 seconds, change legs and repeat. The exercise can be made more difficult by lifting the heel from the ground slightly or passing the ball around your waist and / or under your other knee.
Repetitions: 2 sets (30 sec. on each leg)

Single -leg balance throwing ball with partner
This exercise improves leg muscle coordination and balance.
Assume the starting position, standing 2 – 3 meters apart from your partner, with each of you standing on one leg. Bend your knee and hip slightly so that your upper body leans forwards slightly. When viewed from the front, the hip, knee and foot of your supporting leg are in a straight line. Hold the raised leg slightly behind the supporting leg.
During this exercise, keep your balance while you throw the ball to one another. Hold in your stomach and keep your weight on the ball of your foot. Continue for 30 seconds, change legs and repeat. This exercise can be made more difficult by lifting the heel from the ground slightly.
Repetitions: 2 sets (30 sec. on each leg)


Single -leg balance test your partner
This exercise improves leg muscle coordination and balance.
Assume the starting position, standing at arm’s length from your partner, with each of you standing on one leg. Bend your knee and hip slightly so that your upper body leans forwards slightly. When viewed from the front, the hip, knee and foot of your supporting leg are in a straight line. Hold the raised leg slightly behind the supporting leg.
During this exercise, keep your balance while you and your partner in turn try to push the other off balance in different directions. Keep returning to the starting position.
Continue for 30 seconds, change legs and repeat.
Repetitions: 2 sets (30 sec. on each leg)

SLS+JE intervention group and JE intervention group will perform:
Jumping vertical jumps
This exercise improves your jumping power and movement control.
Assume the starting position, standing with your feet hip-width apart and your hands on your hips.
During this exercise, slowly bend your hips, knees and ankles until your knees are flexed to 90 degrees. Lean your upper body forwards. Hold this position for 1 second, then jump as high as you can. While you jump, straighten your whole body. Land softly on the balls of your feet and slowly bend your hips, knees and ankles as far as possible. Repeat for
30 seconds.
Repetitions: 2 sets (30 sec.)


Jumping lateral jumps
This exercise improves your jumping power and movement control on one leg.
Assume the starting position, standing on one leg. Bend your hips, knee and ankle slightly and lean your upper body forwards.
During this exercise, jump approximately one meter to the side from your supporting leg onto your other leg. Land gently on the ball of your foot and bend your hips, knee and ankle. Hold this position for about a second and then jump onto the other leg. Keep your upper body stable and facing forwards and your pelvis horizontal. Repeat for 30 seconds.
Repetitions: 2 sets (30 sec. each)
Jumping box jumps
This exercise improves body stability through quick movements in different directions.
Assume the starting position, standing with feet hip-width apart and imagine that there is a cross marked on the ground and you are standing in the middle of it.
During this exercise, bend your hips, knees and ankles and from this position alternate between jumping forwards and backwards, from side to side, and diagonally across the cross.
Jump as quickly and explosively as possible. Land gently on the balls of your feet and bend your hips, knees and ankles. Lean your upper body forwards slightly throughout the exercise. Repeat the exercise for 30 seconds.
Repetitions: 2 sets (30 sec. each)
Time between each exercise: 1-3 minute
The frequency/duration of the intervention: 5 -10 minutes before training, three times per week for 6 weeks.
Programs compliance: will be evaluated according to the rate of participation using an attendance log.
Programs administers: Physiotherapist, Senior Physiotherapy students.
Intervention code [1] 313086 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] 308336 0
All groups will perform the pre- post intervention test using Biodex Balance Stability System . The primary outcome measure will be balance.
Timepoint [1] 308336 0
Single assessment after 6 weeks
Secondary outcome [1] 354635 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] 354635 0
Assessed weekly for 6 weeks

Eligibility
Key inclusion criteria
Female athletes
Minimum age
19 Years
Maximum age
25 Years
Sex
Females
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,
SLS and JE interventiongroup (n=20 athletes), SLS intervention group (n= 20 athletes), JE intervention groups (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] 21096 0
Saudi Arabia
State/province [1] 21096 0

Funding & Sponsors
Funding source category [1] 301359 0
University
Name [1] 301359 0
Umm Al Qura University
Country [1] 301359 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al Qura University
Address
Al Awali, Mecca 24381.
Country
Saudi Arabia
Secondary sponsor category [1] 301030 0
None
Name [1] 301030 0
Address [1] 301030 0
Country [1] 301030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302101 0
UQU Research Ethics Committee, Department of Physical Therapy
Ethics committee address [1] 302101 0
PO Box: 715, Makkah, 21955, Saudi Arabia
Ethics committee country [1] 302101 0
Saudi Arabia
Date submitted for ethics approval [1] 302101 0
02/07/2018
Approval date [1] 302101 0
31/08/2018
Ethics approval number [1] 302101 0
PT2018/02

Summary
Brief summary
Background: The effects of the Single-Leg Stance (SLS) and Jumping exercises (JE) have been evaluated and shown reduce in injury incidence significantly. However, the effects of the SLS or JE on improving functional balance have not been investigated and yet may be important. Therefore, we will evaluate the effect of SLS and JE on improving functional balance compared to no intervention, among amateur female athletes.
Methods: female amateur athletes aged 19–25 years will be randomly assigned to SLS and JE intervention (n=2 groups, 20 athletes), SLS intervention (n=2 groups, 20 athletes), JE 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 SLS or JE can improving functional balance among female 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 89114 0
A/Prof Wesam Saleh A. Al Attar
Address 89114 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89114 0
Saudi Arabia
Phone 89114 0
+966548206504
Fax 89114 0
Email 89114 0
[email protected]
Contact person for public queries
Name 89115 0
A/Prof Wesam Saleh A. Al Attar
Address 89115 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89115 0
Saudi Arabia
Phone 89115 0
+966548206504
Fax 89115 0
Email 89115 0
[email protected]
Contact person for scientific queries
Name 89116 0
A/Prof Wesam Saleh A. Al Attar
Address 89116 0
Department of Physical Therapy
College of Applied Medical Sciences
Umm Al Qura University
PO Box: 715, Makkah, 21955,
Country 89116 0
Saudi Arabia
Phone 89116 0
+966548206504
Fax 89116 0
Email 89116 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.