Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001215617p
Ethics application status
Not yet submitted
Date submitted
7/10/2023
Date registered
27/11/2023
Date last updated
27/11/2023
Date data sharing statement initially provided
27/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Loading on Breathing Behaviour, Muscle Activation, and Performance During Unstable versus Stable Load Resistance Training
Scientific title
Effect of Loading on Breathing Behaviour, Muscle Activation, and Performance During Unstable versus Stable Load Resistance Training in healthy males and females
Secondary ID [1] 310755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory function 331714 0
physical function 331715 0
Condition category
Condition code
Respiratory 328463 328463 0 0
Normal development and function of the respiratory system
Musculoskeletal 328464 328464 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study will involve one initial testing session and one experimental session. All sessions will be conducted in an exercise clinic at the University of Sydney Camperdown campus (Susan Wakil Health Building). All sessions will be supervised by a strength and conditioning specialist or exercise scientist with one-on-one supervision provided to participants. The interval between the two sessions will be at least 72 hours to avoid the influence of fatigue. A session attendance checklist will be used to monitor adherence to the sessions.

The initial testing session (120 minutes) will encompass in-person screening, anthropometry, blood pressure, spirometry profile, static balance, dynamic balance, core endurance test, core strength test, and the 1RM parallel back squat.

The experimental session (150 minutes) will involve unstable load training (ULT) and traditional training (TRAD) in parallel back squats. The ULT will be the interventional condition, and the TRAD will be the control condition. A recovery period of approximately 30 minutes will be allowed between conditions to minimise the influence of fatigue.

The ULT (interventional condition) will involve a bout of parallel back squats at various loads in ascending order (40% 1RM, 50% 1RM, 60% 1RM, 70% 1RM, 80% 1RM, 90% 1RM) with unstable loads. The unstable load will be achieved by suspending weight plates on both ends of the barbell using elastic bands (Rogue Fitness, Columbus, OH, USA). The bands will be “quadruple looped” through the hole in the centre of each weight plate and hanging on the barbell. Two repetitions at each percentage of 1RM will be performed with a 60-second rest interval between attempts up to 60% 1RM and 120 seconds for 70-90%. The repetition speed of the squats will involve a 3-second eccentric phase followed by maximum velocity/effort in the concentric phase. A 20-kilogram standard Olympic barbell will be utilised for male participants, whilst a 15-kilogram standard Olympic barbell will be utilised for female participants.
Intervention code [1] 327363 0
Treatment: Other
Comparator / control treatment
The TRAD (control condition) will involve a bout of parallel back squats at various loads in ascending order (40% 1RM, 50% 1RM, 60% 1RM, 70% 1RM, 80% 1RM, 90% 1RM) with stable loads. The stable load will be achieved by placing the plates on both ends of the barbell normally. Two repetitions at each percentage of 1RM will be performed with a 60-second rest interval between attempts up to 60% 1RM and 120 seconds for 70-90%. The repetition speed of the squats will involve a 3-second eccentric phase followed by maximum velocity/effort in the concentric phase. A 20-kilogram standard Olympic barbell will be utilised for male participants, whilst a 15-kilogram standard Olympic barbell will be utilised for female participants.
Control group
Active

Outcomes
Primary outcome [1] 336288 0
Breath behaviour, including inspiratory volume (Vin), expiratory volume (Vex), inspiratory volume / tidal volume (Vin/Vt), expiratory volume / tidal volume (Vex/Vt), rate of breaths, breath-holding occurrence, and breath-holding duration of each squat, will be collected throughout resistance exercise. All components will be assessed together as a composite outcome.
Timepoint [1] 336288 0
Monitored continuously throughout resistance exercise.
Secondary outcome [1] 427675 0
Muscle activation of rectus femoris, vastus lateralis, vastus medialis, biceps femoris, soleus, tibialis anterior, rectus abdominis, external oblique, internal oblique, and erector spinae muscles will be monitored throughout resistance exercise. All components will be assessed together as a composite outcome.
Timepoint [1] 427675 0
Monitored continuously throughout resistance exercise.
Secondary outcome [2] 427676 0
Ground reaction force
Timepoint [2] 427676 0
Monitored continuously throughout resistance exercise.
Secondary outcome [3] 427677 0
Centre of gravity
Timepoint [3] 427677 0
Monitored continuously throughout resistance exercise.
Secondary outcome [4] 428763 0
Average and maximal velocity
Timepoint [4] 428763 0
Monitored continuously throughout resistance exercise.
Secondary outcome [5] 428764 0
perceptual fatigue
Timepoint [5] 428764 0
Immediately after the exercise session.
Secondary outcome [6] 428765 0
Perceived exertion
Timepoint [6] 428765 0
Immediately after squats in each intensity.

Eligibility
Key inclusion criteria
1) familiar with back squat; 2) more than 1-year resistance training experience; 3) averaging at least 2 sessions of resistance training per week during the previous 6 weeks.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) respiratory system disease; 2) cardiovascular disease; 3) kidney disease; 4) glaucoma; 5) inguinal, femoral, or umbilical hernia; 6) lower back pain; 7) ankle instability; 8) flat feet; and 9) neuromuscular disorders or injuries within the past six months.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of the experimental protocols will be randomised by block randomisation (random.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive data will be expressed as mean ±SD. Two-way repeated measures ANOVA will be used to examine the effect of exercise modalities and various intensities on dependent variables. Pearson's correlation coefficients will be calculated. Bonferroni post hoc comparisons will be performed following ANOVA analysis when required. The alpha level will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314987 0
University
Name [1] 314987 0
The University of Sydney
Country [1] 314987 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science. Level 6, Western Avenue, D18-Susan Wakil Health Building, Camperdown, NSW, 2006.
Country
Australia
Secondary sponsor category [1] 317003 0
None
Name [1] 317003 0
Address [1] 317003 0
Country [1] 317003 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313959 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 313959 0
Level 3, Michael Spence Building (F23), Corner of Eastern Avenue and CityRoad, The University of Sydney, Camperdown, NSW, 2006.
Ethics committee country [1] 313959 0
Australia
Date submitted for ethics approval [1] 313959 0
01/01/2024
Approval date [1] 313959 0
Ethics approval number [1] 313959 0

Summary
Brief summary
The primary goal of this acute study is to compare breathing behaviour across various loads during parallel back squats between unstable load training (ULT) and traditional training (TRAD). Secondary objectives involve investigating the effects of stable versus unstable conditions across various loads on muscle activation, exercise stability, mechanical performance and perceptual fatigue.

The primary hypothesis is that there will be a greater inspiratory volume, a higher rate of breaths, a longer duration of breath-holding, and a larger expiratory volume with an increase in load during squats in both the ULT and TRAD conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129926 0
Dr Daniel Hackett
Address 129926 0
The University of Sydney. Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science. Level 6, Western Avenue, D18-Susan Wakil Health Building, Camperdown, NSW, 2006.
Country 129926 0
Australia
Phone 129926 0
+61 424133727
Fax 129926 0
Email 129926 0
daniel.hackett@sydney.edu.au
Contact person for public queries
Name 129927 0
Dr Daniel Hackett
Address 129927 0
The University of Sydney. Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science. Level 6, Western Avenue, D18-Susan Wakil Health Building, Camperdown, NSW, 2006.
Country 129927 0
Australia
Phone 129927 0
+61 424133727
Fax 129927 0
Email 129927 0
daniel.hackett@sydney.edu.au
Contact person for scientific queries
Name 129928 0
Dr Daniel Hackett
Address 129928 0
The University of Sydney. Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science. Level 6, Western Avenue, D18-Susan Wakil Health Building, Camperdown, NSW, 2006.
Country 129928 0
Australia
Phone 129928 0
+61 424133727
Fax 129928 0
Email 129928 0
daniel.hackett@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Available for 15 years after publication (Starting 1st December 2024 and ending on 30th November 2039).
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Access is subject to approvals by Principal Investigator (Dr Daniel Hackett) daniel.hackett@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20626Ethical approval    Once ethics approval is received.



Results publications and other study-related documents

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