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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
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Scientific title
Functional and Structural effects of different iso-inertial resistance training modalities with eccentric overload in young, healthy, active males
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Secondary ID [1]
295717
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Muscle performance
309112
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Muscle architecture
309113
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Condition category
Condition code
Musculoskeletal
307988
307988
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
302040
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
306964
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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.
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Assessment method [1]
306964
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Timepoint [1]
306964
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7 weeks before randomisation, 7 weeks after intervention ends
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Primary outcome [2]
306965
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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).
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Assessment method [2]
306965
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Timepoint [2]
306965
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7 weeks before randomisation, 7 weeks after intervention ends
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Primary outcome [3]
306966
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Changes in maximal dynamic force (1RM). The unilateral 1RM test was conducted on a
4 45o-inclined leg press device (Gerva-Sport, Madrid, Spain).
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Assessment method [3]
306966
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Timepoint [3]
306966
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7 weeks before randomisation, 7 weeks after intervention ends
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Secondary outcome [1]
350269
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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).
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Assessment method [1]
350269
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Timepoint [1]
350269
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7 weeks before randomisation, 7 weeks after intervention ends
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Secondary outcome [2]
350270
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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).
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Assessment method [2]
350270
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Timepoint [2]
350270
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7 weeks before randomisation, 7 weeks after intervention ends
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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.
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Minimum age
18
Years
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Maximum age
28
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
22/04/2018
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Date of last participant enrolment
Anticipated
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Actual
9/05/2018
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Date of last data collection
Anticipated
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Actual
25/06/2018
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
10723
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Spain
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State/province [1]
10723
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León
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Funding & Sponsors
Funding source category [1]
300309
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University
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Name [1]
300309
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University of León
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Address [1]
300309
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Campus de Vegazana
S/N 24007
León, Spain
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Country [1]
300309
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Spain
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Primary sponsor type
University
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Name
University of León
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Address
Campus de Vegazana
S/N 24007
León, Spain
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Country
Spain
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Secondary sponsor category [1]
299755
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None
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Name [1]
299755
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Address [1]
299755
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Country [1]
299755
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301121
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Comité de Ética de la Universidad de León
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Ethics committee address [1]
301121
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Rectorado Avda. de la Facultad, 25 24071 León, Spain
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Ethics committee country [1]
301121
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Spain
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Date submitted for ethics approval [1]
301121
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03/03/2018
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Approval date [1]
301121
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20/04/2018
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Ethics approval number [1]
301121
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ETICA-ULE-009-2018
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Summary
Brief summary
The aim was to analyze whether increasing the eccentric overload during resistance training in terms of range of motion and/or velocity using an electric-motor device, would induce different muscle adaptations than conventional flywheel eccentric overload resistance training. Despite the different eccentric overloads offered by each device, 6 weeks of resistance training using flywheel or electric-motor devices could induce different significant gains in strength, muscle power, vertical jump, and muscle mass.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
2936
2936
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/AnzctrAttachments/375716-Informe DEFINITIVO ETICA-ULE-009-2018-Dr Jose Antonio de Paz Fernandez.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
85922
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Mr Sergio Maroto-Izquierdo
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Address
85922
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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
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Country
85922
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Spain
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Phone
85922
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+34 646 59 30 87
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Fax
85922
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Email
85922
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[email protected]
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Contact person for public queries
Name
85923
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José Antonio de Paz Fernández
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Address
85923
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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
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Country
85923
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Spain
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Phone
85923
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+34 670 578 755
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Fax
85923
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Email
85923
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[email protected]
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Contact person for scientific queries
Name
85924
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Sergio Maroto-Izquierdo
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Address
85924
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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
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Country
85924
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Spain
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Phone
85924
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+34 646 59 30 87
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Fax
85924
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Email
85924
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[email protected]
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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.
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