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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05523674
Other study ID # Warm-up_BRF_FCT/UNESP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2024
Est. completion date December 2024

Study information

Verified date April 2024
Source Paulista University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: warming up has the function of preparing the body structures for a given task to be performed during sports, increasing body and muscle temperature, focusing on improving performance. Therefore, the use of the blood flow restriction technique (BFR) can be seen as a promising alternative for promoting greater mechanical and muscular stress, thus providing a more efficient warm-up and optimizing performance. Objectives: to analyze the effects of RFS used during low-intensity warm-up compared with low-intensity and high-intensity warm-up without RFS on performance (jump test and 30-meter sprint test) and skin surface temperature. In addition to analyzing and comparing, after the warm-up protocols with and without RFS, the acute responses on perceptual outcomes (perception of pain, change in sensitivity, subjective perception of exertion and perception of discomfort in relation to RFS) and muscle outcomes (tonus , muscle stiffness and elasticity). Methods: a randomized controlled clinical trial will be carried out, with 33 amateur soccer players aged between 18 and 35 years who will be randomly divided into three groups: low-intensity warm-up without RFS (30% VO2max), high-intensity warm-up without RFS ( 80% VO2max) and low-intensity warm-up associated with BFR (80% of total occlusion pressure) [30% VO2max-BFR]. All groups will carry out the heating protocol and the outcomes will be evaluated at baseline and immediately after the end of the heating, as well as 10 and 20 minutes after its completion, namely: skin surface temperature through thermography; tone, stiffness and muscle elasticity by myotometry, subjective perception of pain (VAS); pain threshold through the pressure algometer; subjective perception of exertion (BORG scale); perception of discomfort in relation to RFS (LIKERT-CR-10 scale); 30-meter sprints measured through photocells and vertical jump, measured through the force platform. Descriptive statistics will be used and comparisons will be made using the generalized linear mixed model, assuming a significance level of p<0.05.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date December 2024
Est. primary completion date August 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - male - healthy - amateur soccer player - aged between 18 and 35 years Exclusion Criteria: - smokers; - alcoholics; - use drugs that influenced cardiac autonomic activity; - cardiovascular, metabolic or endocrine diseases; - having one or more predisposing risk factors for thromboembolism; - history of lower extremity surgery or musculoskeletal injury within the last six months that may impair your performance during testing or warm-up (e.g., meniscal repair, ligament reconstruction, muscle injury, tendinopathy, lower extremity patellofemoral pain, and/or back pain);

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Warm-up exercise
The warm-up exercise will be performed on a treadmill.
Warm-up exercise with Blood Flow Restriction
The warm-up exercise will be performed on a treadmill and pressure cuffs will be used for the blood flow restriction technique.

Locations

Country Name City State
Brazil Carlos Alberto Toledo Teixeira Filho Presidente Prudente São Paulo
Brazil Franciele Marques Vanderlei Presidente Prudente SP

Sponsors (1)

Lead Sponsor Collaborator
Paulista University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temperature Skin surface temperature will be evaluated using a thermographic camera At the baseline
Primary Temperature Skin surface temperature will be evaluated using a thermographic camera Immediately after warm-up
Primary Performance in Squat Jump Test The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil) At the baseline
Primary Performance in Squat Jump Test The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil) Immediately after warm-up
Primary Performance in 30 meter sprint the sprint test will be performed in a hall and two pairs of photoelectric cells (Multisprint®, Hidrofit, Brazil) will be used with an accuracy of 0.01 seconds. At the baseline
Primary Performance in 30 meter sprint the sprint test will be performed in a hall and two pairs of photoelectric cells (Multisprint®, Hidrofit, Brazil) will be used with an accuracy of 0.01 seconds. Immediately after warm-up
Secondary Pain threshold To assess the pain threshold, the pressure algometer will be applied at 10 specific locations on the lower limb At the baseline
Secondary Pain threshold To assess the pain threshold, the pressure algometer will be applied at 10 specific locations on the lower limb Immediately after warm-up
Secondary Muscle Pain The subjective evaluation of pain will be obtained through the Visual Analogue Scale (VAS), graded from 0 to 10, with zero being the total absence of pain and 10 the maximum level of pain supported by the participan At the baseline
Secondary Muscle Pain The subjective evaluation of pain will be obtained through the Visual Analogue Scale (VAS), graded from 0 to 10, with zero being the total absence of pain and 10 the maximum level of pain supported by the participan Immediately after warm-up
Secondary Perceived Effort Scale (Borg) The degree of subjective exertion reported by the participants in relation to the lower limbs will be analyzed by Borg's scale of perception of effort of 0 to 10 points, 0 being "very easy" and 10 being "exhaustive." At the baseline and Immediately after warm-up
Secondary Perceived discomfort Scale (Likert-RFS) The degree of subjective discomfort reported by the participants in relation to the lower limbs refferd a blood flow restriction will be analyzed by Likert Scale of perception of effort of 0 to 10 points, 0 being "no discomfort" and 10 being "very discomfortable." At the baseline and Immediately after warm-up
Secondary Resistance through Bioimpedance analysis (BIA) Evaluation of tissue resistance, the higher the value, the worse the result At the baseline and Immediately after warm-up
Secondary Reactance through Bioimpedance analysis (BIA) Evaluation of tissue reactance, the higher the value, the better the cell integrity At the baseline and Immediately after warm-up
Secondary Phase angle through Bioimpedance analysis (BIA) Assessment of the phase angle, the higher the value, the better the condition of the participant At the baseline and Immediately after warm-up
Secondary Tone muscular through Myotonometry used the MyotonPRO equipment Natural Oscillation Frequency [Hz], characterizing Tone of the muscles: quadriceps femoris, biceps femoris, semitendinosus, triceps surae and tibialis anterior At the baseline and Immediately after warm-up
Secondary Stiffness through Myotonometry used the MyotonPRO equipment Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the muscles: quadriceps femoris, biceps femoris, semitendinosus, triceps surae and tibialis anterior At the baseline and Immediately after warm-up
Secondary heart rate variability indices in the time domain Mean RR, SDNN e rMSSD At the baseline time (30 minutes rest in the supine position), during the warm-up (15 minutes in the treadmill) and immediately after the warm-up (60 minutes rest in the supine position)
Secondary heart rate variability indices in the frequency domain LF and HF in nu and ms2 At the baseline time (30 minutes rest in the supine position), during the warm-up (15 minutes in the treadmill) and immediately after the warm-up (60 minutes rest in the supine position)
Secondary heart rate variability indices analyzed in the Poincaré plot SD1 and SD2 in ms At the baseline time (30 minutes rest in the supine position), during the warm-up (15 minutes in the treadmill) and immediately after the warm-up (60 minutes rest in the supine position)
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