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Trial registered on ANZCTR


Registration number
ACTRN12617000835347
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
7/06/2017
Date last updated
30/07/2019
Date data sharing statement initially provided
30/07/2019
Date results provided
30/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in movement quality and physical performance in response to an 8 week individualised movement quality assessment informed exercise intervention in apparently healthy adults: A randomised trial.
Scientific title
The changes in movement quality and measures of physical performance in healthy active adults (28-55 y) in response to an 8 week individualized movement quality assessment driven exercise intervention, in comparison to an 8 week traditional resistance training regime.
Secondary ID [1] 291858 0
None
Universal Trial Number (UTN)
U1111-1196-2999
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Movement Quality 303131 0
Physical Performance 303132 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302583 302583 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants within the intervention group will undertake an 8 week individualized exercise regime to improve strength and quality of movement, which will be based upon the results of their individual movement quality assessment outcome score. The exercise intervention will be based around the results of their movement quality assessment, and will be targeting improvements in movement quality. Exercise selection and progression will be determined at the discretion of the trainers providing the intervention based upon their movement quality assessment results.

The Movement quality assessment will involve the evaluation of 9 movements that occur commonly in gym settings, and allow the identification of movement dysfunction and potential muscular imbalances. These movements include the following: a bilateral squat; a forward lunge; a dead-lift with a bent over row; a single leg squat; an overhead reach; a seated thoracic rotation; a 4 point hold with opposite arm and leg lifts (also known as a bird dog); a push up; and an active straight leg raise test. Poor performance on any one (or more) of these test will identify areas of muscular imbalance or dysfunction that will be used to guide subsequent exercise prescription.

The control group will undertake an 8 week traditional resistance training exercise regime to improve strength and aerobic fitness. The trainers providing the training regime to the control group will not have access to their movement quality assessment information, and will not be targeting improvements in movement quality.

Each exercise regime will consist of 2 sessions per week, lasting 60 minutes each session, for a total time commitment of 16 hours per participant over 8 weeks. Every session, for both the intervention and control group, will be one-on-one with a trainer. These sessions will be performed at The University of South Australia's City East Campus Gym facility.

The training performed on both the control and intervention group will be made progressively more challenging by incorporating the principle of progressive overload (increments of 2-10% weekly). All training will be supervised by accredited exercise trainers. The sessions will be performed at a moderate to vigorous intensity, with sessional RPE being obtained at the end of each session.

All sessions will be recorded to provide information on the exercises performed each session, with the loads used for those exercises. The programs will be structured in accordance the ACSM guidelines for exercise prescription, in which each core muscle group will be trained for 3 sets of 8-12 repetitions per session.
Intervention code [1] 297975 0
Treatment: Other
Comparator / control treatment
This study will use a traditional resistance training regime (based upon the principals of the ACSM guidelines for exercise prescription) as the control group. This group will not receive any information from their baseline movement quality assessment.

Based upon these recommendations, each individual in the control group will be performing resistance training using a full body training program, 2 times per week. Each major muscle group of the body (eg. legs, shoulders, chest, back, abdomen, and hips) will be trained each session. There will be at least 48 hours between each session (eg. Monday and Wednesday, Monday and Thursday, Tuesday, and Thursday, Tuesday and Friday, Wednesday and Friday). Compound movements using free weights will be prioritized over machine based and isolation exercises. Exercise progression and selection within this framework will be up to the discretion of the trainers.
Control group
Active

Outcomes
Primary outcome [1] 301998 0
Changes in movement quality as assessed by the movement quality assessment tool MovementSCREEN PRO 'Trademark' (score range from 0-100 points, measured as a percentage)
Timepoint [1] 301998 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [1] 334495 0
3 repetition maximum trap bar deadlift (measured in kilograms)
Timepoint [1] 334495 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [2] 334635 0
3 repetition maximum high bench row (measured in kilograms)
Timepoint [2] 334635 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [3] 334636 0
3 repetition maximum bench press (measured in kilograms)
Timepoint [3] 334636 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [4] 334637 0
Single leg hop distance (measured in centimetres)
Timepoint [4] 334637 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [5] 334638 0
vertical jump height (measured in centimeters)
Timepoint [5] 334638 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [6] 334639 0
broad jump distance (measured in centimeters)
Timepoint [6] 334639 0
Baseline and Post intervention (at the completion of the 8 week training period).
Secondary outcome [7] 335288 0
Maximal oxygen uptake as estimated by the Chester step test (reported in ml/kg/min)
Timepoint [7] 335288 0
Baseline and post intervention (at the completion of the 8 week training period)
Secondary outcome [8] 350795 0
Functional Movement Screen (FMS)
Timepoint [8] 350795 0
Baseline and post intervention (at the completion of the 8 week training period)
Secondary outcome [9] 350796 0
sRPE (borgs CR10 scale) will also be obtained at the completion of each training session.
Timepoint [9] 350796 0
This outcome measure is more exploratory, and was completed at the completion of each training session by every single participant. As there were 16 sessions, this was obtained 16 times.

Eligibility
Key inclusion criteria
People will be eligible for participation if they are considered low risk in accordance with the Exercise and Sports Science Australia (ESSA) adult pre-exercise screening tool. Participants will be excluded if they have any barriers restricting their ability to perform vigorous physical activity, such as pre-existing injury or inadequate time to commit to the intervention.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Are classified as moderate or high risk in accordance with the Exercise and Sports Science Australia (ESSA) adult pre-exercise screening tool.
Have barriers restricting their ability to perform vigorous physical activity, such as pre-existing injury or inadequate time to commit to the intervention.

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)
Participants will not be made aware as to whether they have been placed in the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into one of the two groups using minimisation to balance the groups for age, gender, and current exercise training status. Randomisation and allocation to treatment will be performed by an investigator in a separate building who is not involved in the intervention, data collection or statistical analysis. The primary outcome measure will be undertaken by an independent researcher. The secondary outcomes will be undertaken by the lead investigator due to funding and resource constraints.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Groups will be balanced for age, gender, and current exercise training status.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Treatment effectiveness analysis will be blinded and by intention-to-treat. Continuous data will be explored for normality to satisfy assumptions for parametric statistical analyses. The differences
between groups for primary and secondary outcomes will be assessed using a linear mixed effects model, with intervention group, time and the interaction between these two entered as independent variables. In case of significant missing data, sensitivity analysis will be conducted using imputation where reasonable. A secondary analysis will be conducted to assess the influence of training adherence (as measured by attendance and session completion) on training outcomes. Effect sizes and 95% confidence intervals for the primary and secondary outcomes will also be presented. The level of significance for analyses will be set at p <0.05. Statistical analyses will be performed using Stata software (v14, Statacorp, TX).

A set of pre-specified analyses to investigate potential mechanisms for changes in movement quality and physical performance will be performed. Univariate correlations and separate multiple regression models will be used to explore the relationship between the baseline scores and changes in movement quality as measured by MovementSCREEN (independent variable) and changes in physical performance (dependent variables). Standard assumptions and checks for regression will be followed for all analyses, which will be conducted in STATA (Statacorp, TX, USA).

A total of 60 participants (30 per group) will provide 80% power to detect a difference at a two-sided 0.05 significance level, of 0.8 times the standard deviation, allowing for 13% dropout. There are no pre-existing data on intervention effect sizes from movement quality training specific to that being tested in this study. Therefore, the calculation was performed considering the best available intervention effect size from previous research (Bodden et al 2015), and we have conservatively taken a smaller effect size for this trial.
Recruitment

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2017
Actual
19/06/2017
Date of last participant enrolment
Anticipated
1/11/2018
Actual
18/10/2018
Date of last data collection
Anticipated
28/12/2018
Actual
9/01/2019
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15900 0
5001 - Adelaide
Recruitment postcode(s) [2] 15901 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296357 0
University
Name [1] 296357 0
University of South Australia
Country [1] 296357 0
Australia
Funding source category [2] 296358 0
Commercial sector/Industry
Name [2] 296358 0
Corrective Exercise Australia
Country [2] 296358 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia.
Country
Australia
Secondary sponsor category [1] 295297 0
Commercial sector/Industry
Name [1] 295297 0
Corrective Exercise Australia
Address [1] 295297 0
Corrective Exercise Australia
9 Kensington Rd
Norwood SA 5067
Australia
Country [1] 295297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297587 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 297587 0
Ethics committee country [1] 297587 0
Australia
Date submitted for ethics approval [1] 297587 0
01/04/2017
Approval date [1] 297587 0
09/05/2017
Ethics approval number [1] 297587 0
0000036267

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74530 0
Mr Hunter Bennett
Address 74530 0
University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
Country 74530 0
Australia
Phone 74530 0
+61433377222
Fax 74530 0
Email 74530 0
hunter.bennett@mymail.unisa.edu.au
Contact person for public queries
Name 74531 0
Hunter Bennett
Address 74531 0
University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
Country 74531 0
Australia
Phone 74531 0
+61433377222
Fax 74531 0
Email 74531 0
hunter.bennett@mymail.unisa.edu.au
Contact person for scientific queries
Name 74532 0
Hunter Bennett
Address 74532 0
University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
Country 74532 0
Australia
Phone 74532 0
+61433377222
Fax 74532 0
Email 74532 0
hunter.bennett@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To retain participant anonymity.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3506Informed consent form    372868-(Uploaded-29-07-2019-12-51-15)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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