Healthy MenNCT05523674

Effects of Warm-up Intensity and Blood Flow Restriction

A study testing Warm-up exercise and Warm-up exercise with Blood Flow Restriction in people with Healthy Men, run by Paulista University at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Men
What is being tested?: Warm-up exercise and Warm-up exercise with Blood Flow Restriction
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 2 sitesBrazil
Study dates: 15 Mar 2024to 15 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

male
healthy
amateur soccer player
aged between 18 and 35 years

Who cannot join

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);

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Carlos Alberto Toledo Teixeira Filho
Presidente Prudente, São Paulo, 19060-900
Franciele Marques Vanderlei
Presidente Prudente, São Paulo, 55

Other trials in Brazil

About this study

Official title: Effects of Warm-up Intensity and Blood Flow Restriction: A Randomized Controlled Clinical Trial

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.

Conditions: Healthy Men
Being tested: Warm-up exercise, Warm-up exercise with Blood Flow Restriction
Keywords: Vascular occlusion, Performance, Body temperature, warm-up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Warm-up exerciseOther
Also called Warming-up, Aerobic Exercise
The warm-up exercise will be performed on a treadmill.
Warm-up exercise with Blood Flow RestrictionOther
Also called Warming-up, Aerobic Exercise, 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.

Study groups in NCT05523674
Study group	Role	What they receive
warm-up performed at 30% VO2max	Experimental	The warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes duration, with the first 5 minutes of acceleration, until reaching 30% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown. Receives: Other: Warm-up exercise
warm-up performed at 80% VO2max	Experimental	The warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes duration, with the first 5 minutes of acceleration, until reaching 80% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown. Receives: Other: Warm-up exercise
warm-up performed at 30% VO2max with Blood Flow Restriction	Experimental	The warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes of duration, with the first 5 minutes of acceleration, until reaching 30% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown. During the warm-up exercise, a pressure cuff will be used on each leg, with the blood flow restriction technique (80% of arterial occlusion pressure). Receives: Other: Warm-up exercise with Blood Flow Restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

Temperature
Skin surface temperature will be evaluated using a thermographic camera
Measured: At the baseline
Temperature
Skin surface temperature will be evaluated using a thermographic camera
Measured: Immediately after warm-up
Performance in Squat Jump Test
The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)
Measured: At the baseline
Performance in Squat Jump Test
The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)
Measured: Immediately after warm-up
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.
Measured: At the baseline
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.
Measured: Immediately after warm-up

Secondary outcomes (14)

Pain threshold
To assess the pain threshold, the pressure algometer will be applied at 10 specific locations on the lower limb
Measured: At the baseline
Pain threshold
To assess the pain threshold, the pressure algometer will be applied at 10 specific locations on the lower limb
Measured: Immediately after warm-up
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
Measured: At the baseline
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
Measured: Immediately after warm-up
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."
Measured: At the baseline and Immediately after warm-up
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."
Measured: At the baseline and Immediately after warm-up
Resistance through Bioimpedance analysis (BIA)
Evaluation of tissue resistance, the higher the value, the worse the result
Measured: At the baseline and Immediately after warm-up
Reactance through Bioimpedance analysis (BIA)
Evaluation of tissue reactance, the higher the value, the better the cell integrity
Measured: At the baseline and Immediately after warm-up
Phase angle through Bioimpedance analysis (BIA)
Assessment of the phase angle, the higher the value, the better the condition of the participant
Measured: At the baseline and Immediately after warm-up
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
Measured: At the baseline and Immediately after warm-up
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
Measured: At the baseline and Immediately after warm-up
heart rate variability indices in the time domain
Mean RR, SDNN e rMSSD
Measured: 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)
heart rate variability indices in the frequency domain
LF and HF in nu and ms2
Measured: 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)
heart rate variability indices analyzed in the Poincaré plot
SD1 and SD2 in ms
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202415 Dec 2024

First posted31 Aug 2022
Study start15 Mar 2024
Primary completion20 Aug 2024
Study completion15 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy MenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05523674
Sponsor's protocol ID: Warm-up_BRF_FCT/UNESP
Status last verified: May 2025
First submitted: 11 Aug 2022
Last updated: 31 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Warm-up Intensity and Blood Flow Restriction: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05523674
Acronym / sponsor ID: Warm-up_BRF_FCT/UNESP
Conditions: Healthy Men
Keywords: Vascular occlusion, Performance, Body temperature, warm-up
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Paulista UniversityUniversity, hospital or other
Study start: 15 Mar 2024 (actual)
Primary completion: 20 Aug 2024 (actual)
Study completion: 15 Dec 2024 (actual)
First posted: 31 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
warm-up performed at 30% VO2max	Experimental	Other: Warm-up exerciseThe warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes duration, with the first 5 minutes of acceleration, until reaching 30% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown.
warm-up performed at 80% VO2max	Experimental	Other: Warm-up exerciseThe warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes duration, with the first 5 minutes of acceleration, until reaching 80% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown.
warm-up performed at 30% VO2max with Blood Flow Restriction	Experimental	Other: Warm-up exercise with Blood Flow RestrictionThe warm-up exercise will be performed on an ergometric treadmill, through a protocol of 15 minutes of duration, with the first 5 minutes of acceleration, until reaching 30% of VO2max, the following 5 minutes of maintenance and the remaining 5 minutes being of slowdown. During the warm-up exercise, a pressure cuff will be used on each leg, with the blood flow restriction technique (80% of arterial occlusion pressure).

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

male
healthy
amateur soccer player
aged between 18 and 35 years

Key exclusion criteria (6 listed)

smokers;
alcoholics;
use drugs that influenced cardiac autonomic activity;
cardiovascular, metabolic or endocrine diseases;
having one or more predisposing risk factors for thromboembolism;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Warm-up exerciseAlso: Warming-up, Aerobic ExerciseThe warm-up exercise will be performed on a treadmill.	Other	warm-up performed at 30% VO2max, warm-up performed at 80% VO2max
Warm-up exercise with Blood Flow RestrictionAlso: Warming-up, Aerobic Exercise, Blood Flow RestrictionThe warm-up exercise will be performed on a treadmill and pressure cuffs will be used for the blood flow restriction technique.	Other	warm-up performed at 30% VO2max with Blood Flow Restriction

Primary outcome

Temperature
Time frame: At the baseline
Skin surface temperature will be evaluated using a thermographic camera
Temperature
Time frame: Immediately after warm-up
Skin surface temperature will be evaluated using a thermographic camera
Performance in Squat Jump Test
Time frame: At the baseline
The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)
Performance in Squat Jump Test
Time frame: Immediately after warm-up
The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)
Performance in 30 meter sprint
Time frame: At the baseline
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.
Performance in 30 meter sprint
Time frame: Immediately after warm-up
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.

14 secondary outcomes

Pain threshold
Time frame: At the baseline
Pain threshold
Time frame: Immediately after warm-up
Muscle Pain
Time frame: At the baseline
Muscle Pain
Time frame: Immediately after warm-up
Perceived Effort Scale (Borg)
Time frame: At the baseline and Immediately after warm-up
Perceived discomfort Scale (Likert-RFS)
Time frame: At the baseline and Immediately after warm-up
Resistance through Bioimpedance analysis (BIA)
Time frame: At the baseline and Immediately after warm-up
Reactance through Bioimpedance analysis (BIA)
Time frame: At the baseline and Immediately after warm-up
Phase angle through Bioimpedance analysis (BIA)
Time frame: At the baseline and Immediately after warm-up
Tone muscular through Myotonometry used the MyotonPRO equipment
Time frame: At the baseline and Immediately after warm-up
Stiffness through Myotonometry used the MyotonPRO equipment
Time frame: At the baseline and Immediately after warm-up
heart rate variability indices in the time domain
Time frame: 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)
heart rate variability indices in the frequency domain
Time frame: 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)
heart rate variability indices analyzed in the Poincaré plot
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Warm-up exercise and Warm-up exercise with Blood Flow Restriction in people with Healthy Men, run by Paulista University at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature (time frame: At the baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.