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Trial registered on ANZCTR


Registration number
ACTRN12613000233729
Ethics application status
Approved
Date submitted
18/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of delivery method, supervised versus home-based, on outcomes of core strengthening programs
Scientific title
The effect of core strengthening program delivery method (supervised vs home-based) on core stability measures in healthy individuals with low core stability
Secondary ID [1] 281970 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low core stability 288397 0
Condition category
Condition code
Musculoskeletal 288744 288744 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 288789 288789 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
supervised core strengthening program run by an exercise scientist twice per week for 8 weeks
versus
home based intervention consisting of one initial instruction session and written instructions for a home based program of 2 sessions per week for 8 weeks

The instruction session for the home-based group took place in the first week of the intervention and consisted of verbal instructions and demonstrations of the exercises in the program, including feedback on exercise execution. They were also shown how to record the exercises executed during their training sessions in their exercise journal.

The core strengthening programs for the supervised group and the home based group are identical (except for the supervision vs written instructions) and consist of:
Warm up; cat/camel and abdominal contractions (supine, quadruped and side bridge on knees)
The exercises consisted of Dead bug, side bridging, bird-dog, hip abduction in side lying, lunges and stability ball exercises. The number of sets and duration of contractions were gradually increased throughout the 8 week program, as was the complexity of the exercises.

All exercise sessions were designed to take approximately 25 minutes to complete, so total training time was 2 x 25 minutes per week for 8 weeks.
Intervention code [1] 286538 0
Treatment: Other
Intervention code [2] 286575 0
Rehabilitation
Comparator / control treatment
control consists of no intervention
Control group
Active

Outcomes
Primary outcome [1] 288885 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Sahrmann Test
Timepoint [1] 288885 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Primary outcome [2] 288934 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Star Excursion Balance Test
Timepoint [2] 288934 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Primary outcome [3] 288935 0
Change from baseline test measure as difference in individual tests scores in the following test:
Muscle thickness of Transversus Abdominis as measured by diagnostic ultrasound
Timepoint [3] 288935 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Secondary outcome [1] 301245 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Side bridge endurance test
Timepoint [1] 301245 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Secondary outcome [2] 301385 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Flexor endurance test
Timepoint [2] 301385 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Secondary outcome [3] 301386 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Back extensor endurance test
Timepoint [3] 301386 0
Baseline,
Upon completion of exercise intervention (8 weeks)
Secondary outcome [4] 301387 0
Change from baseline test performance measures as difference in individual tests scores in the following test:
Trendelenberg test
Timepoint [4] 301387 0
Baseline,
Upon completion of exercise intervention (8 weeks)

Eligibility
Key inclusion criteria
Healthy volunteers with low core stability as determined by a score of 1 or less in the Sahrmann Test
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- current pregnancy
- current acute specific low back pain or lower limb injury
- musculoskeletal, neurological, systemic or local pathology affecting balance, neuromuscular control or altering muscle response to exercise
- previous or current participation in core strengtehing classes or any form of core strengthening program

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286754 0
University
Name [1] 286754 0
University of Newcastle
Priority Research Centre in Physical Activity & Nutrition
Address [1] 286754 0
Priority Research Centre in Physical Activity & Nutrition
Level 3
Advanced Technology Centre
The University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country [1] 286754 0
Australia
Primary sponsor type
Individual
Name
Xanne Janse de Jonge
Address
Exercise Science Building
School of Environmental and Life Sciences
Faculty of Science & IT
University of Newcastle
PO box 127 Ourimbah
NSW 2258
Country
Australia
Secondary sponsor category [1] 285534 0
Individual
Name [1] 285534 0
Vivienne Chuter
Address [1] 285534 0
Health Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127 Ourimbah
NSW 2258
Country [1] 285534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288823 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 288823 0
Human Research Ethics Administration
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 288823 0
Australia
Date submitted for ethics approval [1] 288823 0
Approval date [1] 288823 0
08/05/2012
Ethics approval number [1] 288823 0
H-2012-0013

Summary
Brief summary
Poor core stability is associated with dysfunction and weakness of muscles of the trunk, pelvis and hip (core muscles) and the development of lower limb pathology and low back pain. Core strengthening programs aim to prevent injury and increase stability through improved strength and co-ordination of core muscle activity (Faries & Greenwood, 2007). However, the delivery method of training programs is highly variable and despite widespread use, the evidence for injury treatment and prevention with core strengthening programs is inconclusive. This may be due to the heterogeneity of delivery methods of programs used as the intervention. Investigation of the most effective delivery method of core strengthening programs is required to enable accurate evaluation of efficacy core strengthening interventions. The aim of this project is to compare the effect of supervised core strengthening classes, a home-based core strengthening program and no intervention on specific measures of core stability. It is hypothesised that supervised classes will 1) result in a greater improvement in performance in tests assessing core strength, and 2) increased transversus abdominus (TrA) hypertrophy when compared to a home-based program and no intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37918 0
Dr Vivienne Chuter
Address 37918 0
Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
Country 37918 0
Australia
Phone 37918 0
+61 2 43494424
Fax 37918 0
Email 37918 0
vivienne.chuter@newcastle.edu.au
Contact person for public queries
Name 37919 0
Dr Vivienne Chuter
Address 37919 0
Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
Country 37919 0
Australia
Phone 37919 0
+61 2 43494424
Fax 37919 0
Email 37919 0
vivienne.chuter@newcastle.edu.au
Contact person for scientific queries
Name 37920 0
Dr Vivienne Chuter
Address 37920 0
Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
Country 37920 0
Australia
Phone 37920 0
+61 2 43494424
Fax 37920 0
Email 37920 0
vivienne.chuter@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary