- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679971
Effects of Inter-Set Rest Intervals on Muscle Damage After Flywheel Exercise in Untrained Men (RCT)
Effects of Different Inter-Set Rest Intervals on Indirect Markers of Muscle Damage and Mechanical Parameters After Flywheel Resistance Training in Untrained Men: A Randomized Parallel-Group Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Participants will complete seven laboratory visits. The first two visits will be used for baseline assessments and test-retest reliability. The third and fourth visits will be used for technical familiarization with the flywheel exercises. The fifth visit will include the experimental flywheel resistance exercise session and immediate post-exercise assessments. The sixth and seventh visits will include follow-up assessments 48 and 96 hours after the experimental session, respectively. Blood samples for creatine kinase and lactate dehydrogenase will be collected before the experimental session and 72 hours after exercise in a partner laboratory.
The experimental session will include squat, Romanian deadlift, knee extension, and knee flexion exercises performed using flywheel devices. All groups will perform the same exercises, volume, inertia, and execution instructions. The only difference between groups will be the inter-set rest interval: 1 minute, 2 minutes, or 3 minutes.
Study Type
Enrollment (Estimated)
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 of Viçosa
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Contact:
- Study Coordinator
- Phone Number: (31) 98359-5541
- Email: wanderson.machado@ufv.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 40 years;
- Apparently healthy and clinically able to perform physical exercise;
- No participation in structured resistance training during the previous 6 months;
- Agreement to comply with all study visits and procedures;
- Signed informed consent form.
Exclusion Criteria:
- History of lower-limb musculoskeletal injury or surgery that may impair performance or safety during the proposed exercise protocol;
- Current pain, injury, or functional limitation in the lower limbs;
- Use of ergogenic aids that may affect physical performance or muscle recovery;
- Use of analgesic or anti-inflammatory medication during the study period;
- Failure to attend the scheduled visits required for the primary outcome assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1-Minute Inter-set Rest Interval
Participants allocated to this group will perform a single lower-limb flywheel resistance exercise session using a 1-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
|
Participants will perform a single lower-limb flywheel resistance exercise session using a 1-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
Each exercise will be performed for 4 sets of 2 preparatory repetitions followed by 8 valid repetitions, using the same flywheel inertia, exercise order, and execution instructions across all groups.
Participants will be instructed to perform the concentric phase as fast as possible and to brake the eccentric phase during the final portion of the movement.
The interval between exercises will be standardized at 3 minutes.
|
|
Experimental: 2-Minute Inter-set Rest Interval
Participants allocated to this group will perform a single lower-limb flywheel resistance exercise session using a 1-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
|
Participants will perform a single lower-limb flywheel resistance exercise session using a 2-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
Each exercise will be performed for 4 sets of 2 preparatory repetitions followed by 8 valid repetitions, using the same flywheel inertia, exercise order, and execution instructions across all groups.
Participants will be instructed to perform the concentric phase as fast as possible and to brake the eccentric phase during the final portion of the movement.
The interval between exercises will be standardized at 3 minutes.
|
|
Experimental: 3-Minute Inter-set Rest Interval
Participants allocated to this group will perform a single lower-limb flywheel resistance exercise session using a 1-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
|
Participants will perform a single lower-limb flywheel resistance exercise session using a 3-minute inter-set rest interval.
The session will include squat, Romanian deadlift, knee extension, and knee flexion exercises.
Each exercise will be performed for 4 sets of 2 preparatory repetitions followed by 8 valid repetitions, using the same flywheel inertia, exercise order, and execution instructions across all groups.
Participants will be instructed to perform the concentric phase as fast as possible and to brake the eccentric phase during the final portion of the movement.
The interval between exercises will be standardized at 3 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in maximal voluntary isometric contraction of the knee extensors
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
Maximal voluntary isometric contraction of the knee extensors will be assessed using a load cell with the knee positioned at 90 degrees of flexion.
The primary outcome will be the change in force between baseline and immediately, 48 hours, and 96 hours after the experimental exercise session using a flywheel.
|
Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
|
Change in maximal voluntary isometric contraction of the knee flexors
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
The maximum voluntary isometric contraction of the knee flexors will be assessed using a load cell with the knee positioned at 45 degrees of flexion.
The primary outcome will be the change in force between baseline and immediately, 48 hours, and 96 hours after the experimental exercise session using a flywheel.
|
Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in vastus lateralis and biceps femoris long head muscle thickness
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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|
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Change in vastus lateralis and biceps femoris long head echo intensity
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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|
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Change in countermovement jump performance
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
|
|
Change in active and passive knee flexion and extension range of motion
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
|
|
Change in lower-limb muscle soreness score assessed by the Visual Analogue Scale
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
Lower-limb muscle soreness will be assessed using a 100-mm Visual Analogue Scale.
The scale ranges from 0 to 100, where 0 indicates no pain and 100 indicates the worst possible pain.
Higher scores indicate greater muscle soreness.
The outcome will be reported as the change in muscle soreness score from baseline to the post-exercise time points.
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Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
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Change in pressure pain threshold of the thigh muscles
Time Frame: Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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Baseline, 10 minutes after the experimental exercise session, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
|
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Change in serum creatine kinase and lactate dehydrogenase concentrations
Time Frame: Pre-exercise and 72 hours after the experimental exercise session
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Pre-exercise and 72 hours after the experimental exercise session
|
|
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Peak concentric and eccentric power output during flywheel exercise
Time Frame: During all 16 sets performed in the experimental exercise session
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Peak concentric and eccentric power output will be recorded during each valid repetition of the flywheel exercise session using a load cell connected to the flywheel device.
Data will be collected for all sets and exercises, excluding the initial preparatory repetitions.
The outcome will be reported as peak concentric power, peak eccentric power, and eccentric/concentric power ratio across the experimental exercise session.
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During all 16 sets performed in the experimental exercise session
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Rating of perceived exertion assessed by the OMNI-Resistance Exercise Scale
Time Frame: After each of the 16 sets performed during the experimental exercise session and 10 minutes after the experimental exercise session
|
Rating of perceived exertion will be assessed using the OMNI-Resistance Exercise Scale.
The scale ranges from 0 to 10, where 0 indicates extremely easy and 10 indicates extremely hard.
Higher scores indicate greater perceived exertion.
The outcome will be reported after each set of the experimental flywheel exercise session and 10 minutes after the end of the session.
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After each of the 16 sets performed during the experimental exercise session and 10 minutes after the experimental exercise session
|
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Perceived discomfort assessed by the Discomfort Scale
Time Frame: After each of the 16 sets performed during the experimental exercise session and 10 minutes after the experimental exercise session
|
Perceived discomfort will be assessed using a 0-to-100 Discomfort Scale.
The scale ranges from 0 to 100, where 0 indicates no discomfort and 100 indicates maximal discomfort.
Higher scores indicate greater perceived discomfort.
The outcome will be reported after each set of the experimental flywheel exercise session and 10 minutes after the end of the session.
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After each of the 16 sets performed during the experimental exercise session and 10 minutes after the experimental exercise session
|
|
Perceived recovery status assessed by the Perceived Recovery Status Scale
Time Frame: Baseline, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
|
Perceived recovery status will be assessed using the Perceived Recovery Status Scale.
The scale ranges from 0 to 10, where 0 indicates very poor recovery and 10 indicates full recovery.
Higher scores indicate better perceived recovery.
The outcome will be reported as the perceived recovery status score at baseline and at the post-exercise follow-up time points.
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Baseline, 48 hours after the experimental exercise session, and 96 hours after the experimental exercise session
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 7.151.525 (Other Identifier: Ethics Committee Approval Number)
- 81740024.5.0000.5153 (Other Identifier: CAAE)
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
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