Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000095662
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
24/01/2014
Date last updated
24/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Can exercise change core stability in recreational athletes?
Scientific title
The effect of a stability training program compared to stretching exercises on lumbopelvic stability in recreational athletes
Secondary ID [1] 283753 0
Nil
Universal Trial Number (UTN)
U1111-1151-2517
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbopelvic stability 290723 0
Condition category
Condition code
Musculoskeletal 291090 291090 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STABILITY TRAINING PROGRAM
The participants will be asked to perform a 12 week lumbopelvic stability training program 3 times per week at home. they will perform 1-2 sets of 5-12 repetitions of the exercises. The program takes less than 15 minutes to perform.

The program will be delivered with video instructions and a poster. To assist with correct timing and technique participants will also be provided with a video that they can perform the exercises with. The videos will be made available to participants via a dedicated internet site.

The stability training program comprises four exercises, each of which has four levels, with Level 1 being the easiest. The exercises commence in well-supported positions, performing only small movements and progress to increasingly challenging exercises with larger ranges of movement in positions that challenge lumbopelvic stability. Each exercise has criteria describing competent performance. The participants will progress at their own rate to the next level when competent at that level. Exercise technique can be checked with the researchers using a phone app (provided as part of the study) that provides visual and verbal feedback. Participants may not reach the highest level of each exercise during the 12 weeks. An outline of the exercises follows.


Exercise 1 - single leg squat progressing to squats with trunk and arm rotation. The participant squats down as far as possible while keeping the trunk upright and the heel on the floor.
Level 1 - supported
Perform single leg squat with fingers on a wall to assist balance.
Level 2 - unsupported
Single leg squat without external support.
Level 3 - "running man"
Single leg squat with alternating arm movements.
Level 4 - rotation
Arms held forward, rotate trunk to side while performing squat.

Exercise 2 - arabesque movement progressing to weighted arm rotations.
The arabesque start position is standing on one leg with the knee bent 30 degrees and the trunk inclined forwards to 60 degrees. The participant rotates the arm opposite to the stance leg towards the ceiling by rotating their pelvis over their stance leg.
Level 1 - suppported
Performs the arabesque movement with fingers on a wall to assist balance.
Level 2 - unsupported
Performs the arabesque movement without external support.
Level 3 - weight
Performs the same movement with a weight (0.5-1kg) in their hand.
Level 4 - eyes closed
Performs the movement with a weight and their eyes closed.

Exercise 3 - side plank progressing to rotation movement and leg & arm lifts.
The start position is lying on the side with the participant resting on their forearm. The participant performs the plank movement by lifting their trunk and hips up to form a straight line between shouders, hips and toes.
Level 1 - side plank
Lift into the side plank position.
Level 2 - arm lift
Lift into the side plank position while raising the arm towards the ceiling.
Level 3 - roll side to side
Participant starts in the front plank position, rolls to one side, rolls back to front plank position and rolls to other side.
Level 4 - arm & leg lift
Lifts into side plank position and lifting the top leg and arm at the same time

Exercise 4 - prone plank progressing from elbows to hands and adding leg lifts.
Level 1 - prone plank
Lifts hips into plank position to form a straight line between shouders, hips and toes.
Level 2 - elbows to hands
Lifts up into the plank position and lifts up on to each hand and then lowers to each elbow.
Level 3 - "crab crawl"
The participant lifts into the plank position on the hands. They lift one hand and foot to move to one side, returns to the centre, moves to the other side and returns to the centre.
Level 4 - arm & leg lift
The participant lifts into the plank position on the hands and then lifts one hand and the opposite leg.
Adherence to exercise protocol
1) Participants have access to exercise videos so that they can check correct technique.
2) Participants are provided with an app free of charge that can be used to send video of their exercise performance to the investigator for feedback on correct technique.
3) Adherence to the exercise program is monitored weekly via sms with response rewarded by entry to a gift voucher draw. Prompt response is rewarded by 2 entries in the draw.
4) Weekly monitoring by sms will act as a reminder to perform the exercises.
Intervention code [1] 288437 0
Treatment: Other
Comparator / control treatment
STRETCHING TRAINING PROGRAM
The participants will be asked to perform a 12 week stretching training program 3 times per week at home. The program takes less than 15 minutes to perform.

The program will be delivered with video instructions and a poster. Participants will also be provided with a video that they can perform the exercises with to assist with correct timing and technique. The videos will be made available to participants via a decicated internet site.
Exercise technique can be checked with the researchers using a phone app (provided as part of the study) that provides visual and verbal feedback.

The stretching training program comprises stretches for six muscle groups attached to the lumbopelvic region: hamstrings, quadriceps, adductors, gluteals, trunk rotators and hip flexors. The participants should feel a strong but comfortable stretch and hold each stretch for 30 seconds. The stretches are performed on each side.

Adductors
The participant will stand with the feet apart, transferring their weight to one side. They will move their buttocks slightly backwards to feel a stretching sensation on the inside of their thigh.

Quadriceps
The participant will use one hand to hold the foot behind them with the knee pointing downwards to feel a stretching sensation in the front of the thigh. They will balance on a wall if necessary.

Hamstrings
The participant will kneel on one knee with the other leg stretched out in front to feel a stretching sensation in the back of their thigh.

Hip flexors
The participant will kneel on one leg with the other foot on the floor in front of them. They will move their hips forward to feel a stretching sensation on the front of the back hip.

Gluteals
The participant will sit on the floor with one leg out in front. They will bend the other knee and place the foot on the outside of the first leg. They will pull their bent knee towards their chest using the opposite arm. They should feel a stretching sensation in the outside of the hip and the buttocks of the leg that is bent.

Trunk rotators
The participant will lie on one side with the knees bent. They will twist their upper body to the opposite side to feel a stretch in the lower back.
Control group
Active

Outcomes
Primary outcome [1] 291073 0
Clinical rating of lumbopelvic stability - good, poor, or neither good nor poor
Clinical rating of lumbopelvic stability is assessed as either good, poor or neither good nor poor using rating criteria previously established by the investigators (Perrott, Pizzari, Cook, & Opar, 2011). The rating criteria have clear descriptions of good and poor performance of these tests. Blinded raters will watch video of single leg squat and dip test and rate the performance of the tests as either good, poor or neither good nor poor.
Perrott, M. A., Pizzari, T., Cook, J., & Opar, M. S. (2011). Development of clinical rating criteria for tests of lumbo-pelvic stability. Rehabilitation Research and Practice. Retrieved from http://www.hindawi.com/journals/rerp/2012/803637/ doi:10.1155/2012/803637
Timepoint [1] 291073 0
Baseline, 12 weeks and 12 months after intervention commencement
Primary outcome [2] 291074 0
Kinematic angles of trunk, pelvis and thigh during 8 movement tests.
1. balancing on one leg,
2. pelvic leveling – standing with the pelvis level, moving and repositioning the pelvis in a level position again,
3. single leg squat – squat down on one leg and return to the upright position,
4. dip test – same as single leg squat using a support for the back foot for balance,
5. hurdle step - stepping over a low hurdle,
6. a lunge,
7. turning manoeuvre – running towards a mark, planting the foot and turning to one side,
8. hopping side to side
Timepoint [2] 291074 0
Baseline, 12 weeks and 12 months after intervention commencement
Secondary outcome [1] 305969 0
Balance Error Scoring System (BESS) - score 0-10
Timepoint [1] 305969 0
Baseline, 12 weeks and 12 months after intervention commencement
Secondary outcome [2] 305971 0
Clinical rating of hurdle step performance - score 0-3
Timepoint [2] 305971 0
Baseline, 12 weeks and 12 months after intervention commencement
Secondary outcome [3] 305973 0
Clinical rating of lunge performance - score 0-3
Timepoint [3] 305973 0
Baseline, 12 weeks and 12 months after intervention commencement
Secondary outcome [4] 306485 0
Sporting exposure - hours per week
Timepoint [4] 306485 0
Baseline
Secondary outcome [5] 306486 0
Ankle mobility - dorsiflexion range of movement in degrees
Timepoint [5] 306486 0
Baseline

Eligibility
Key inclusion criteria
Recreational athletes taking part in land based sports.
Willingness to perform movement testing 3 times - baseline, 12 weeks and 12 months post-intervention
Willingness to participate in a 12 week exercise program
Willingness to participate in a 12 month follow up program
Access to internet and smartphone
Able to read and understand English
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Acute injury at the time of baseline testing
History of lower limb or back surgery
Neurological or systemic diseases potentially affecting capacity to complete the testing and/or intervention.

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)
Volunteers who respond to advertising, will undergo a phone screening to determine eligibility. Eligible participants who consent to participate will complete baseline movement testing. Their performance on two tests (single leg squat and dip test) will be videoed and two of the researchers will rate their lumbopelvic stability as either good, poor or neither good nor poor. This rating system has been previously validated. Those classified as having good lumbopelvic stability will continue their usual training. All other participants will be randomised to the stability program or the stretching program.
Allocation to exercise groups will be concealed by using an off-site trial administrator who holds the randomisation schedule. They will not be involved in any other role in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be performed using a random sequence generator at http://www.random.org/sequences/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
One hundred and fifty recreational athletes will be recruited. The sample size is based on the clinically relevant ability to detect change in lumbopelvic stability after stability training in those with poor stability. Previous research shows a range of sample sizes from 18-44 where stability training changed isolated aspects of LPS, or reduced pain and disability.
This sample size range is supported by a power calculation based on previous research investigating the effect of a stability and agility program compared to a stretching program on recurrent hamstring strain.
To detect differences between the two interventions in the current study and achieve a power of 0.8-0.9 at an alpha level of p that is less than or equal to 0.05, df = 1, using chi square, a sample size of 25-34 with poor LPS would be required. Previous research has yielded 14 individuals with poor LPS from a population of 62 recreational athletes. A sample size of 150 recreational athletes would be expected to yield 34 participants with poor LPS. This should ensure a sufficiently large sample size to detect changes in LPS in those with poor stability.

Data analysis: clinical rating
Lumbopelvic stability will be compared before and after intervention using chi square.
Performance scores for balance, hurdle step and lunge will be compared before and after intervention using Friedman two-way analysis of variance by ranks.
The correlation between clinical rating (good, poor or neither good nor poor) and performance scores will be analysed using Spearman rho at baseline, 12 weeks and 12 months to establish if there is an association between clinical rating and performance scores on other tests.
The relationship between clinical rating and sporting exposure and between clinical rating and ankle mobility will be analysed using one-way ANOVA.
Data analysis - kinematic measures
Kinematic measures related to lumbopelvic stability will be compared before and after intervention using mixed two way ANOVA (group by time). This comparison will be made at baseline, 12 weeks and 12 months to determine if an exercise program changes the amount that athletes move.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
29/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288447 0
University
Name [1] 288447 0
La Trobe University, Bundoora Melbourne
Country [1] 288447 0
Australia
Primary sponsor type
University
Name
La Trobe University, Bundoora Melbourne
Address
La Trobe University,
Department of Physiotherapy,
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 287151 0
None
Name [1] 287151 0
Address [1] 287151 0
Country [1] 287151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290321 0
La Trobe University Faculty Human Ethics Committee
Ethics committee address [1] 290321 0
La Trobe University,
Department of Physiotherapy,
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Ethics committee country [1] 290321 0
Australia
Date submitted for ethics approval [1] 290321 0
Approval date [1] 290321 0
31/07/2013
Ethics approval number [1] 290321 0
FHC13/121

Summary
Brief summary
This project investigates whether lumbopelvic or "core" stability in recreational athletes is improved by 12 weeks of stability or stretching exercises. Participants' movement control of the back, pelvis and thigh will be assessed at baseline, 12 weeks and 12 months after baseline to determine the influence of exercise training on stability.
The hypothesis is that the stability training program will achieve measurable and superior results in lumbopelvic control compared to the stretching program
Trial website
Trial related presentations / publications
Perrott MA, Pizzari T, Cook C. Lumbopelvic exercise reduces lower limb muscle strain injury in recreational athletes Physical Therapy Reviews. 2013;18(1):24-33.

Perrott M, Pizzari T, Cook J, Opar MS. Development of clinical rating criteria for tests of lumbo-pelvic stability. Rehabilitation Research and Practice [Internet]. 2011 Available from: http://www.hindawi.com/journals/rerp/2012/803637/.
Public notes

Contacts
Principal investigator
Name 44926 0
Ms Margaret Perrott
Address 44926 0
La Trobe University,
Department of Physiotherapy,
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country 44926 0
Australia
Phone 44926 0
+61 432 980 300
Fax 44926 0
Email 44926 0
[email protected]
Contact person for public queries
Name 44927 0
Ms Margaret Perrott
Address 44927 0
La Trobe University,
Department of Physiotherapy,
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country 44927 0
Australia
Phone 44927 0
+61 432 980 300
Fax 44927 0
Email 44927 0
[email protected]
Contact person for scientific queries
Name 44928 0
Ms Margaret Perrott
Address 44928 0
La Trobe University,
Department of Physiotherapy,
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country 44928 0
Australia
Phone 44928 0
+61 432 980 300
Fax 44928 0
Email 44928 0
[email protected]

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