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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
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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
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Secondary ID [1]
281970
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
low core stability
288397
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Condition category
Condition code
Musculoskeletal
288744
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0
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Normal musculoskeletal and cartilage development and function
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Physical Medicine / Rehabilitation
288789
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Rehabilitation
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Comparator / control treatment
control consists of no intervention
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Control group
Active
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Outcomes
Primary outcome [1]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Sahrmann Test
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Assessment method [1]
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Timepoint [1]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Primary outcome [2]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Star Excursion Balance Test
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Assessment method [2]
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Timepoint [2]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Primary outcome [3]
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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
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Assessment method [3]
288935
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Timepoint [3]
288935
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Secondary outcome [1]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Side bridge endurance test
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Assessment method [1]
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Timepoint [1]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Secondary outcome [2]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Flexor endurance test
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Assessment method [2]
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Timepoint [2]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Secondary outcome [3]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Back extensor endurance test
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Assessment method [3]
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Timepoint [3]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Secondary outcome [4]
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Change from baseline test performance measures as difference in individual tests scores in the following test:
Trendelenberg test
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Assessment method [4]
301387
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Timepoint [4]
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Baseline,
Upon completion of exercise intervention (8 weeks)
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Eligibility
Key inclusion criteria
Healthy volunteers with low core stability as determined by a score of 1 or less in the Sahrmann Test
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/05/2012
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Actual
15/05/2012
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Date of last participant enrolment
Anticipated
26/06/2012
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Actual
10/07/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Newcastle
Priority Research Centre in Physical Activity & Nutrition
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Address [1]
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Priority Research Centre in Physical Activity & Nutrition
Level 3
Advanced Technology Centre
The University of Newcastle
University Drive
Callaghan NSW 2308
Australia
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Country [1]
286754
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Australia
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Primary sponsor type
Individual
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Name
Xanne Janse de Jonge
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Address
Exercise Science Building
School of Environmental and Life Sciences
Faculty of Science & IT
University of Newcastle
PO box 127 Ourimbah
NSW 2258
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Vivienne Chuter
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Address [1]
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Health Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127 Ourimbah
NSW 2258
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Country [1]
285534
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
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Human Research Ethics Administration Research Services Research Integrity Unit HA148, Hunter Building The University of Newcastle University Drive Callaghan NSW 2308
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Ethics committee country [1]
288823
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Australia
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Date submitted for ethics approval [1]
288823
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Approval date [1]
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08/05/2012
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Ethics approval number [1]
288823
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H-2012-0013
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vivienne Chuter
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Address
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Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
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Country
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Australia
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Phone
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+61 2 43494424
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Vivienne Chuter
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Address
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Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
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Country
37919
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Australia
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Phone
37919
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+61 2 43494424
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Fax
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Email
37919
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[email protected]
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Contact person for scientific queries
Name
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Vivienne Chuter
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Address
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Health Science Precinct
School of Health Sciences
Faculty of Health
University of Newcastle
PO Box 127
Ourimbah 2258 NSW
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Country
37920
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Australia
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Phone
37920
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+61 2 43494424
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Fax
37920
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Email
37920
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
The efficacy of a supervised and a home-based core strengthening programme in adults with poor core stability: a three-arm randomised controlled trial.
2015
https://dx.doi.org/10.1136/bjsports-2013-093262
N.B. These documents automatically identified may not have been verified by the study sponsor.
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