Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000227594
Ethics application status
Approved
Date submitted
23/09/2023
Date registered
7/03/2024
Date last updated
7/03/2024
Date data sharing statement initially provided
7/03/2024
Date results information initially provided
7/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Jump height and peak isometric force changes after different combinations of training volume and training intensities using velocity-based training in a flywheel half-squat exercise
Scientific title
Immediate exercise-induced neuromuscular changes after different external loads and velocity losses combinations in the flywheel squat exercise in physically active adults
Secondary ID [1] 310668 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced neuromuscular changes 331572 0
Condition category
Condition code
Musculoskeletal 328307 328307 0 0
Normal musculoskeletal and cartilage development and function
Cardiovascular 328308 328308 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised flywheel half-squat exercise, with different combinations of three velocity losses thresholds (5%, 10% and 15%) and three external loads or moments of inertia (0.05 kg·m2, 0.10 kg·m2, and 0.15 kg·m2). More specifically, the combinations will be:
1. Combination 1: Velocity Loss 5%, 0.05 kg·m2 moment of inertia
2. Combination 2: Velocity Loss 5%, 0.10 kg·m2 moment of inertia
3. Combination 3: Velocity Loss 5%, 0.15 kg·m2 moment of inertia
4. Combination 4: Velocity Loss 10%, 0.05 kg·m2 moment of inertia
5. Combination 5: Velocity Loss 10%, 0.10 kg·m2 moment of inertia
6. Combination 6: Velocity Loss 10%, 0.15 kg·m2 moment of inertia
7. Combination 7: Velocity Loss 15%, 0.05 kg·m2 moment of inertia
8. Combination 8: Velocity Loss 15%, 0.10 kg·m2 moment of inertia
9. Combination 9: Velocity Loss 15%, 0.15 kg·m2 moment of inertia

Each participant will execute three combinations on a single session, repeated twice a week, with 48-72h interspersed (wash-out period). Each session will last about 60 min per participant, and the total intervention duration will be five weeks. Each session will be attended by pairs.
The flywheel device will be a cylindrical shaft FRTD (Kbox 3, Exxentrix, Sweeden), with a load range ranging from 0.005 to 0.300 kg·m2 and an axis radius width of 0.025 m, monitored with a rotary encoder (SmartCoach Lite, SmartCoach Tech, USA). The main intervention will be supervised by a sport scientist with expertise in the execution of resistance training with flywheel devices.
Intervention code [1] 327076 0
Rehabilitation
Comparator / control treatment
Because it is a cross-over design, each participant will serve as own reference comparator. The Combination 1: Velocity Loss 5%, 0.05 kg·m2 moment of inertia is considered as reference comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 336155 0
Peak isometric force (PIF)
Timepoint [1] 336155 0
baseline and immediate post-exercise in every combination execution throughout the intervention period (two times a week for 3 weeks)
Primary outcome [2] 336156 0
Maximum rate of force development (MRFD)
Timepoint [2] 336156 0
baseline and immediate post-exercise in every combination execution throughout the intervention period (two times a week for 3 weeks)
Primary outcome [3] 336157 0
Jump height (CMJ)
Timepoint [3] 336157 0
baseline and immediate post-exercise in every combination execution throughout the intervention period (two times a week for 3 weeks)
Secondary outcome [1] 427162 0
mean velocity
Timepoint [1] 427162 0
assessed continuously throughout every exercise combination during the exercise execution component completed throughout the intervention period (two times a week for 3 weeks)

Eligibility
Key inclusion criteria
Participants will be required to be at least 18 years old and to have been participating regularly in physical activities that engage the muscles of the lower limbs for a minimum of the last six months. The participants will have previous experience in performing the main exercise (a minimum of three months, twice a week).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who have medical conditions that prevent them from participating in vigorous and intense physical exercises or who have any form of injury, disease, or pathology will not be included in the study.

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)
This study follows a crossover design with a repeating measures component, allowing participants to run the study under their own control. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/01/2023
Date of last participant enrolment
Anticipated
Actual
1/03/2023
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
30
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 25782 0
Spain
State/province [1] 25782 0
Sevilla

Funding & Sponsors
Funding source category [1] 314889 0
University
Name [1] 314889 0
University of Seville
Country [1] 314889 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla
Address
Facultad de Ciencias de la Educación, C/pirotecnica n.13 ZIP 41013 Seville, Spain
Country
Spain
Secondary sponsor category [1] 316890 0
None
Name [1] 316890 0
Address [1] 316890 0
Country [1] 316890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313884 0
Universidad de Sevilla
Ethics committee address [1] 313884 0
Calle San Fernando n.4 41004 Seville, Spain
Ethics committee country [1] 313884 0
Spain
Date submitted for ethics approval [1] 313884 0
12/12/2022
Approval date [1] 313884 0
13/04/2023
Ethics approval number [1] 313884 0
0390-N23

Summary
Brief summary
The objective of this study was to analyse the effect of different training volumes and training intensities in the flywheel half squat exercise. It will be executed by healthy active subjects, both men and women, over 18 years old. Subjects will execute the flywheel half squat exercise twice a week, with different combinations of velocity losses (volume) and moments of inertia (intensity). We will test peak isometric force, maximum rate of force development, and jump height.
Trial website
Trial related presentations / publications
Public notes
The recruitment process started before the final ethics committee approval, but using the same recruiting policies approved by the ethics committee. We started the recruitment process before because the local ethics committee allow for that in our case.

Contacts
Principal investigator
Name 129666 0
Dr Alejandro Muñoz López
Address 129666 0
Facultad de Ciencias de la Educación, C/ Pirotecnia n.13 Office 4.116, ZIP 41013 Seville
Country 129666 0
Spain
Phone 129666 0
+34699661447
Fax 129666 0
Email 129666 0
amunoz26@us.es
Contact person for public queries
Name 129667 0
Dr Alejandro Muñoz López
Address 129667 0
Facultad de Ciencias de la Educación, C/ Pirotecnia n.13 Office 4.116, ZIP 41013 Seville
Country 129667 0
Spain
Phone 129667 0
+34699661447
Fax 129667 0
Email 129667 0
amunoz26@us.es
Contact person for scientific queries
Name 129668 0
Dr Alejandro Muñoz López
Address 129668 0
Facultad de Ciencias de la Educación, C/ Pirotecnia n.13 Office 4.116, ZIP 41013 Seville
Country 129668 0
Spain
Phone 129668 0
+34699661447
Fax 129668 0
Email 129668 0
amunoz26@us.es

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


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
No additional documents have been identified.