- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06924060
EFFECT OF RESISTANCE TRAINING VOLUME WITH INERTIAL FLYWHEEL ON MUSCLE ADAPTATIONS IN UNTRAINED MEN (RCT)
EFFECT OS RESISTANCE TRAINING VOLUME WITH INERTIAL FLYWHEEL ON MUSCLE ADAPTATIONS IN UNTRAINED MEN: A RANDOMIZED CLINICAL TRIAL
Muscular strength is essential for health and quality of life, impacting body composition, balance, locomotion, functional independence, and mental health. Resistance training (RT) is the primary way to increase strength and muscle hypertrophy. Traditionally, RT programs rely on gravity, which can limit muscle activation, especially during the eccentric phase of movement. To improve outcomes, it is important to include methods that intensify muscle work during this phase.
Flywheel resistance Training (FWRT) was developed to increase overload during the eccentric phase by harnessing the energy generated during the concentric phase and applying it to the eccentric phase. This type of training has shown positive results in several studies, improving strength, hypertrophy, jump performance, aerobic endurance, agility, and running economy.
However, there are still no studies that define how the variables of FWRT should be effectively prescribed. Properly adjusting these variables can optimize muscle adaptations and improve physical fitness and health indices. Therefore, in this study, the number of sets will be evaluated to investigate whether a higher number of sets can lead to greater muscle adaptations.
Study Overview
Status
Conditions
Detailed Description
Thirty young men will be randomly assigned to three groups: 2 sets, 3 sets, and 4 sets of Flywheel Resistance Training (FWRT). The interventions will take place at the Department of Physical Education at the Federal University of Vicosa, with all sessions supervised by certified physical education professionals. Follow-up will be conducted through WhatsApp messages and phone calls. All groups will train twice a week for eight weeks. Participants from all experimental groups will perform FWRT on a multi-leg isoinertial machine targeting both upper and lower body muscles. Each session will include 4 exercises, performed for 8 repetitions, with a 2-minute rest between sets and exercises. Training progression will be adjusted based on the participant's ability to exceed the suggested maximum repetitions with the same mobilized weight. The exercises will target various muscle groups, including leg extensions, leg curls, bicep curls, and triceps french press.
Participants will be evaluated at two points during the training program: pre-intervention and post-intervention. Muscle strength of the upper and lower limbs will be assessed through one-repetition maximum (1RM) tests on a knee extension or elbow flexion machine and through maximum voluntary isometric contraction (MVIC), evaluated with a load cell. The muscle thickness of the knee extensors and elbow flexors will be measured using a B-mode ultrasound. Load control will be monitored through the following scales: Total Quality of Recovery (TQR) and Visual Analog Scale for Delayed Onset Muscle Soreness (VAS-DOM), and after each set, by the Subjective Perception of Effort (OMNI-RES). To ensure adequate protein intake, at the end of each training session, participants will receive a dose of Whey Protein, based on data collected from their initial food recall and determined by a nutritionist. Anthropometric evaluation will include the measurement of: a) body mass using an electronic/digital scale with 100g resolution , and b) height using a millimetric stadiometer. The procedures used for body mass and height measurement will follow the protocols based on the measurement standards of the International Society for the Advancement of Anthropometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minas Gerais
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Viçosa, Minas Gerais, Brazil, 36570-900
- Federal University at Viçosa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-reported levels of speaking, writing and understanding Portuguese;
- Availability to participate in the research (initial meeting, initial and final tests, data collection);
- Have not been performing traditional resistance exercises for at least 6 months (untrained subjects);
- Have no previous experience with inertial flywheel devices;
- Answer no to all questions on the Physical Activity Risk Questionnaire - PAR-Q;
- Have no medical contraindication of any kind.
Exclusion Criteria:
- Have a history of recent osteomyoarticular injury;
- Have uncontrolled chronic diseases;
- Surgical procedures scheduled during interventions;
- Do not have the flexibility to adapt their diet to the guidelines offered during collection;
- Use medications or supplements that may interfere with the result, acting as an intervening variable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 2 sets group
Group that will perform two sets of each exercise developed during the intervention.
The other training variables will be identical (repetitions, moment of inertia, rest intervals between sets and repetitions, rest intervals between workouts, training frequency, number and order of exercises).
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For each training session, 4 generic exercises will be performed, involving small and large muscle groups (leg extension, leg flexion, biceps curl, triceps french press).
They will perform 2 sets of 8 repetitions, with a 2-minute break between exercises and sets.
They will perform these exercises at a high intensity (always 10 on the OMNI-RES Scale).
Other Names:
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Experimental: 4 sets group
Group that will perform four sets of each exercise developed during the intervention.
The other training variables will be identical (repetitions, moment of inertia, rest intervals between sets and repetitions, rest intervals between workouts, training frequency, number and order of exercises).
|
For each training session, 4 generic exercises will be performed, involving small and large muscle groups (leg extension, leg flexion, biceps curl, triceps french press).
They will perform 4 sets of 8 repetitions, with a 2-minute break between exercises and sets.
They will perform these exercises at a high intensity (always 10 on the OMNI-RES Scale).
Other Names:
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|
Experimental: 6 sets arm
Group that will perform six sets of each exercise developed during the intervention.
The other training variables will be identical (repetitions, moment of inertia, rest intervals between sets and repetitions, rest intervals between workouts, training frequency, number and order of exercises).
|
For each training session, 4 generic exercises will be performed, involving small and large muscle groups (leg extension, leg flexion, biceps curl, triceps french press).
They will perform 6 sets of 8 repetitions, with a 2-minute break between exercises and sets.
They will perform these exercises at a high intensity (always 10 on the OMNI-RES Scale).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum isometric voluntary contraction (upper extremities)
Time Frame: Baseline and after eight weeks
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To evaluate the Maximum isometric voluntary contraction (MIVC) of the upper extremities, a load cell or extensometric cell with a sampling frequency of 1000 Hz will be used.
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Baseline and after eight weeks
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Maximum isometric voluntary contraction (lower extremities)
Time Frame: Baseline and after eight weeks
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To evaluate the Maximum isometric voluntary contraction (MIVC) of the lower extremities, a load cell or extensometric cell with a sampling frequency of 1000 Hz will be used.
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Baseline and after eight weeks
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1 RM test (elbow flexors)
Time Frame: Baseline and after eight weeks
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To perform the one repetition maximum (1RM) test, the load cell will be placed on a Cross Over machine (Scorpions Fitness, Brazil), so that one of its ends is fixed by means of a chain to the lower part of a stirrup-type handle and the other end is fixed to the steel cable, which is subjected to traction when the machine's lever arm is moved.
Before performing the test, the device will be adjusted so that the subject's elbow is at a 90° flexion angle.
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Baseline and after eight weeks
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1 RM test (knee extension)
Time Frame: Baseline and after eight weeks
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To perform the one repetition maximum test (1RM), the knee extension exercise or elbown flexion will be used on a BH fitness® Nevada Pro-t extension machine.
To perform the test, the volunteer will be asked to extend the knee to form an angle of approximately 180° (final position) and return to the initial position.
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Baseline and after eight weeks
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Muscle power (upper extremities)
Time Frame: Baseline and after eight weeks
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The evaluation of power elbow flexors will be assessed using the same machine used to assess 1RM.
The load for assessing power should be used, obtained from the percentage value of 1RM (40%, 60% and 80% of 1RM), so that the subject performs the elbow flexion movement (concentric phase of the movement) at the highest possible speed.
The return of the elbow to the initial position will be performed in a controlled manner, with a pause of one to two seconds, to prevent the effect of the accumulated elastic force from interfering with the next execution.
A linear position transducer or Encoder will be used, with a sampling frequency of 1000 Hertz to determine the power values.
Through this instrument it will be possible to obtain information on average muscle power (MMP) and peak muscle power (PP).
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Baseline and after eight weeks
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Muscle power (lower extremities)
Time Frame: Baseline and after eight weeks
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The evaluation of lower limb muscle power will be performed using the same knee extension machine used in the exercise sessions, starting from the same initial position (90º of kneeling flexion) and reaching the same final position (180º of knee extension) as the test of 1RM.
The load for assessing power should be used, obtained from the percentage value of 1RM (40%, 60% and 80% of 1RM), so that the subject performs the knee extension movement (concentric phase of the movement) at the highest possible speed.
The return of the knee to the initial position will be performed in a controlled manner, with a pause of one to two seconds, to prevent the effect of the accumulated elastic force from interfering with the next execution.
A linear position transducer or Encoder will be used, with a sampling frequency of 1000 Hertz.
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Baseline and after eight weeks
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Muscle adaptations
Time Frame: Baseline and after eight weeks
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The muscle thickness of the knee extensors and elbow flexors will be measured using a B-mode ultrasound.
Image acquisition will be performed by an experienced and previously trained researcher.
The image will be considered suitable for analysis when the muscle-bone and subcutaneous adipose tissue-muscle interfaces are identified.
The image will then be saved and analyzed in Image-J by the same experienced evaluator.
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Baseline and after eight weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Delayed Onset Muscle Soreness
Time Frame: Before each training session during the 8 weeks of intervention
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To assess the history of Delayed Onset Muscle Soreness, the Visual Analog Scale for Delayed Onset Muscle Soreness (VAS-DOM) will be used to identify whether there are changes throughout the intervention for this variable, that is, whether the volunteer gets used to the intervention and feels less pain throughout the sessions.
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Before each training session during the 8 weeks of intervention
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Subjective Perception of Effort
Time Frame: Before each training session during the 8 weeks of intervention
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To assess the subjective perception of effort, the Subjective Perception of Effort (OMINI-RES) scale will be used, in order to identify whether there are changes throughout the intervention for this variable, that is, whether the volunteer gets used to the intervention and feels a lower perception of effort throughout the sessions.
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Before each training session during the 8 weeks of intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Osvaldo C Moreira, PhD supervisor, Federal University of Vicosa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 81740024.5.0000.5153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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