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Trial registered on ANZCTR


Registration number
ACTRN12618001323213
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
6/08/2018
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the musculoskeletal effects of different iso-inertial resistance training modalities: Flywheel vs. Electric-Motor
Scientific title
Functional and Structural effects of different iso-inertial resistance training modalities with eccentric overload in young, healthy, active males
Secondary ID [1] 295717 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle performance 309112 0
Muscle architecture 309113 0
Condition category
Condition code
Musculoskeletal 307988 307988 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty healthy males participated in the study. They were randomly divided into 3 experimental training groups and 1 control group, which did not train. Participants in the training groups completed 6 weeks (12 sessions) of unilateral, flywheel, single-leg squat resistance exercise. In two of the groups, the resistance was generated by an electric-motor device, configured in iso-inertial mode, and employing two different velocities in the eccentric actions; 100% with respect to concentric speed (experimental group 1; EX1), or 150% with respect to concentric speed (experimental group 2; EX2) (participantes were required to perform each concentric action at their own maximal speed; eccentric resistance is provided by the electric-motor device in base of the concentric speed, imitating a iso-inercial device). The third training group used a conventional flywheel device (experimental group 3; FW). Each training session consisted of 4 sets of 7 maximal concentric repetitions performed 2 times per week. Thigh muscle mass, unilateral maximal dynamic strength (1 repetition maximum; 1RM), bilateral and unilateral vertical jump performance, and unilateral muscle power at different percentages of 1RM were assessed approximately 1 week before and after the training period. Training protocols and tests were carried out by Sports Scientist and a Doctor.
Intervention code [1] 302040 0
Treatment: Devices
Comparator / control treatment
The subjects were randomly located in the control group. All of them were subjects of the same characteristics. Participants of the control group were asked to maintain their weekly physical activity habits during the study period. The subjects were asked not to modify their eating habits, rest, training. The control group participants only carried out the pre and post tests, with the objective of comparing the training effects between participants who have undergone intervention and those who have not suffered it.
Control group
Active

Outcomes
Primary outcome [1] 306964 0
Changes in muscle power
Unilateral muscle power was assessed at different loads of the Maximum Strength (1RM) in a Leg press device. Peak velocity, and average and peak power for each repetition were sampled at 1000 Hz using an encoder (T-FORCE Dynamic Measurement System, Ergotech Consulting S.L., Murcia, Spain) and the associated software (T-Force 21 v. 2.28) for each leg.
Timepoint [1] 306964 0
7 weeks before randomisation, 7 weeks after intervention ends
Primary outcome [2] 306965 0
Muscle mass volume.
Changes in muscle mass were assessed by dual energy X-ray absorptiometry analysis using a Lunar Prodigy® whole-body scan (GE Medical Systems, Madison, WI). Then, a manual analysis was performed to estimate thigh muscle mass (Encore® 2009 software, Lunar Corp., Madison, WI).
Timepoint [2] 306965 0
7 weeks before randomisation, 7 weeks after intervention ends
Primary outcome [3] 306966 0
Changes in maximal dynamic force (1RM). The unilateral 1RM test was conducted on a
4 45o-inclined leg press device (Gerva-Sport, Madrid, Spain).
Timepoint [3] 306966 0
7 weeks before randomisation, 7 weeks after intervention ends
Secondary outcome [1] 350269 0
Unilateral vertical jump performance. Jump height was measured for three types of jumps performed bilaterally and unilaterally on a contact platform (Globus Ergotester®, Globus, Codogne, Italy).
Timepoint [1] 350269 0
7 weeks before randomisation, 7 weeks after intervention ends
Secondary outcome [2] 350270 0
Bilateral vertical jump performance. Jump height was measured for three types of jumps performed bilaterally and unilaterally on a contact platform (Globus Ergotester®, Globus, Codogne, Italy).
Timepoint [2] 350270 0
7 weeks before randomisation, 7 weeks after intervention ends

Eligibility
Key inclusion criteria
Men between 18 and 28 years
Moderately active healthy individuals.
Engaged in 6–8 h of recreational physical activity per week.
Without history of regular lower limb strength training and no previous muscle joint or bone injury for the last 6 months.
Minimum age
18 Years
Maximum age
28 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Muscle joint or bone injury for the last 6 months.
Chronic pathologie.
Less than 6 hours of physical active per week.
Athletes.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At least 10 participants per group (n total 40).
We will run a 3-was anova to know and compare the effects of the tree treatments and the effects between the training leg and the non-training leg.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/04/2018
Date of last participant enrolment
Anticipated
Actual
9/05/2018
Date of last data collection
Anticipated
Actual
25/06/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 10723 0
Spain
State/province [1] 10723 0
León

Funding & Sponsors
Funding source category [1] 300309 0
University
Name [1] 300309 0
University of León
Country [1] 300309 0
Spain
Primary sponsor type
University
Name
University of León
Address
Campus de Vegazana
S/N 24007
León, Spain
Country
Spain
Secondary sponsor category [1] 299755 0
None
Name [1] 299755 0
Address [1] 299755 0
Country [1] 299755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301121 0
Comité de Ética de la Universidad de León
Ethics committee address [1] 301121 0
Ethics committee country [1] 301121 0
Spain
Date submitted for ethics approval [1] 301121 0
03/03/2018
Approval date [1] 301121 0
20/04/2018
Ethics approval number [1] 301121 0
ETICA-ULE-009-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2936 2936 0 0
/AnzctrAttachments/375716-Informe DEFINITIVO ETICA-ULE-009-2018-Dr Jose Antonio de Paz Fernandez.pdf (Ethics approval)

Contacts
Principal investigator
Name 85922 0
Mr Sergio Maroto-Izquierdo
Address 85922 0
Sergio Maroto Izquierdo
Universidad de León
Campus de Vegazana, s/n
Facultad de Ciencias de la Actividad Física y del Deporte
Despacho 85
24071, León
Country 85922 0
Spain
Phone 85922 0
+34 646 59 30 87
Fax 85922 0
Email 85922 0
smaroi@unileon.es
Contact person for public queries
Name 85923 0
José Antonio de Paz Fernández
Address 85923 0
José Antonio de Paz Fernández
Universidad de León
Campus de Vegazana, s/n
Facultad de Ciencias de la Actividad Física y del Deporte
Despacho 81
24071, León
Country 85923 0
Spain
Phone 85923 0
+34 670 578 755
Fax 85923 0
Email 85923 0
japazf@unileon.es
Contact person for scientific queries
Name 85924 0
Sergio Maroto-Izquierdo
Address 85924 0
Sergio Maroto Izquierdo
Universidad de León
Campus de Vegazana, s/n
Facultad de Ciencias de la Actividad Física y del Deporte
Despacho 85
24071, León
Country 85924 0
Spain
Phone 85924 0
+34 646 59 30 87
Fax 85924 0
Email 85924 0
smaroi@unileon.es

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
No additional documents have been identified.