Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000355572
Ethics application status
Approved
Date submitted
11/10/2023
Date registered
27/03/2024
Date last updated
27/03/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of analogy and internal focus instruction on muscular activity, force production and affective response during lifting.
Scientific title
Effects of analogy and internal focus instruction on muscular activity, force production and affective response during lifting in novice people.
Secondary ID [1] 310779 0
‘Nil known’
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle function 331745 0
Condition category
Condition code
Musculoskeletal 328494 328494 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Visit 1:
All participants, after a familiarization with questionnaires related to affective responses, and warm up consisting of mobility exercises, hip hinge and Good Morning exercises, 3 dynamics lifts and 3 isometric pulls increasing at 5/10, 7/10 and 9/10 of maximum RPE, participants will perform the following protocol:
3 repetitions of a dynamic task of 25 kg which consists of lifting the load from the ground, similar to a deadlift without receiving any instruction.After a two-minute rest, the isometric deadlift task will begin. Here, participants will perform three maximal repetitions of three seconds duration under the control condition, in which they will be provided with a neutral instruction, such as "try to get up".

On visit 2, the same protocol will be performed again from warm-up under "no instruction" or control condition to analyze the reliability and reproducibility of the procedure by measuring the same variables in both tasks.

After this, the total number of participants will be randomly divided into two groups. The first group will perform the dynamic task of lifting weights under an explicit instruction. The other group, after familiarization with an instruction by analogy, will perform the task under this condition.

Explicit instructions consist in saying: “Don’t pull with your arm” “Make strength with your lower limbs” and analogy: “Make the lift simulating the task before” after putting under invincible resistance on a smith machine and doing a isometric squat movement.

Each group, after doing the dynamic task, will perform the isometric task under the same instruction previously performed. All participants, before each isometric repetition and the beginning of dynamic movement, will be instructed again to remember where to place their attention.

On visit 3, the same procedure will be performed, counterbalancing the experimental conditions between the groups, making the task dynamic and static under the instruction not used on visit 2, so that the group that was instructed under analogy will perform the tasks under the instruction with explicit features and vice versa.

On visit 4, participants will be invited to perform the dynamic and static task again under the instruction that they have adopted as the best for them.

People will go 4 times to laboratory in two weeks with at least 48 hours of separation between visits. A sport scientist with 10 years of experience in strength & coach will lead the intervention, supervised by thesis doctoral director.

The intervention will be placed face-to-face and will be carried out at the Sport Science Laboratory, located at CED Pirotecnia (Calle Pirotecnia, 41013 Sevilla).
Intervention code [1] 327185 0
Behaviour
Comparator / control treatment
This intervention will be a crossover study where all participants, at the beginning will be under control condition. Control condition consist in using a neutral instruction as "try to stand up"
Control group
Active

Outcomes
Primary outcome [1] 336311 0
force production
Timepoint [1] 336311 0
The measurement of maximum isometric force will occur on four separate days. Specifically, it will be assessed during the baseline measurements on day 1 and day 2, which are associated with the control condition. Additionally, on day 2, the measurement will be taken during the first experimental condition. On day 3, the assessment will focus on the experimental condition not performed during the visit on day 2. Lastly, on day 4, the measurement will be conducted without providing any specific instructions.
Primary outcome [2] 337500 0
affective responses
Timepoint [2] 337500 0
The measurement of maximum isometric force will occur on four separate days. Specifically, it will be assessed during the baseline measurements on day 1 and day 2, which are associated with the control condition. Additionally, on day 2, the measurement will be taken during the first experimental condition. On day 3, the assessment will focus on the experimental condition not performed during the visit on day 2. Lastly, on day 4, the measurement will be conducted without providing any specific instructions.
Secondary outcome [1] 427818 0
muscular activity
Timepoint [1] 427818 0
The measurement of muscular activity will occur on four separate days. Specifically, it will be assessed during the baseline measurements on day 1 and day 2, which are associated with the control condition. Additionally, on day 2, the measurement will be taken during the first experimental condition. On day 3, the assessment will focus on the experimental condition not performed during the visit on day 2. Lastly, on day 4, the measurement will be conducted without providing any specific instructions.

Eligibility
Key inclusion criteria
participants of any gender, of legal age, will participate in the study. The main inclusion criteria will be not having experience with a deadlift teaching-learning process and not having regularly participated in strength-oriented physical exercise programs.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with clinical issues as injuries or mental health disease that could affect during task.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be shown in the text as mean ± standard deviation. First, we will test the data for normality using the Shapiro-Wilk. Next, we compared changes between CONTROL – ANALOGY AND EXPLICIT experimental conditions using a one-way ANOVA repeated measures test. If a statistically significant value is observed, the Tukey post-hoc test will be used comparing between each of the conditions (i.e., CONTROL vs ANALOGY, ANALOGY vs EXPLICIT, CONTROL vs EXPLICIT). We will use the partial eta-squared as a measure of effect size. Statistical significance will be set considering an alpha level of 0.05. All analyzes will be performed using JASP software (JASP Team-2020, Version 0.14.1). We will perform a power analysis to calculate what the statistical power is based on the number of participants recruited through G*POWER.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
2/10/2023
Date of last data collection
Anticipated
Actual
22/12/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 25895 0
Spain
State/province [1] 25895 0
Seville

Funding & Sponsors
Funding source category [1] 315909 0
Self funded/Unfunded
Name [1] 315909 0
Country [1] 315909 0
Primary sponsor type
Individual
Name
Angel Carnero
Address
C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country
Spain
Secondary sponsor category [1] 317032 0
None
Name [1] 317032 0
Address [1] 317032 0
Country [1] 317032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313981 0
Comisión Ética para Investigación con seres Humanos (CEIH) of Pablo de Olavide University
Ethics committee address [1] 313981 0
Ethics committee country [1] 313981 0
Spain
Date submitted for ethics approval [1] 313981 0
16/06/2023
Approval date [1] 313981 0
26/09/2023
Ethics approval number [1] 313981 0

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

Contacts
Principal investigator
Name 130010 0
Mr Angel Carnero Diaz
Address 130010 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 130010 0
Spain
Phone 130010 0
+34666633451
Fax 130010 0
Email 130010 0
[email protected]
Contact person for public queries
Name 130011 0
Angel Carnero Diaz
Address 130011 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 130011 0
Spain
Phone 130011 0
+34666633451
Fax 130011 0
Email 130011 0
[email protected]
Contact person for scientific queries
Name 130012 0
Angel Carnero Diaz
Address 130012 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 130012 0
Spain
Phone 130012 0
+34666633451
Fax 130012 0
Email 130012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
data collected during the trial about muscle activity, force production and affective responses will be shared.
When will data be available (start and end dates)?
following publication data will be available in the university of Seville repository with no end date.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator thorough [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20643Study protocol  [email protected]
20644Statistical analysis plan  [email protected]
20645Data dictionary  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.