NCT05523674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

August 11, 2022

Last Update Submit

May 27, 2025

Conditions

Keywords

Vascular occlusionPerformanceBody temperaturewarm-up

Outcome Measures

Primary Outcomes (6)

  • Temperature

    Skin surface temperature will be evaluated using a thermographic camera

    At the baseline

  • Temperature

    Skin surface temperature will be evaluated using a thermographic camera

    Immediately after warm-up

  • Performance in Squat Jump Test

    The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)

    At the baseline

  • Performance in Squat Jump Test

    The squat jump test will be performed at jumping platform (Multisprint, Hidrofit, Brazil)

    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.

    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.

    Immediately after warm-up

Secondary Outcomes (14)

  • Pain threshold

    At the baseline

  • Pain threshold

    Immediately after warm-up

  • Muscle Pain

    At the baseline

  • Muscle Pain

    Immediately after warm-up

  • Perceived Effort Scale (Borg)

    At the baseline and Immediately after warm-up

  • +9 more secondary outcomes

Study Arms (3)

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.

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.

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).

Other: Warm-up exercise with Blood Flow Restriction

Interventions

The warm-up exercise will be performed on a treadmill.

Also known as: Warming-up, Aerobic Exercise
warm-up performed at 30% VO2maxwarm-up performed at 80% VO2max

The warm-up exercise will be performed on a treadmill and pressure cuffs will be used for the blood flow restriction technique.

Also known as: Warming-up, Aerobic Exercise, Blood Flow Restriction
warm-up performed at 30% VO2max with Blood Flow Restriction

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy
  • amateur soccer player
  • aged between 18 and 35 years

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carlos Alberto Toledo Teixeira Filho

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

MeSH Terms

Interventions

Warm-Up ExerciseExerciseBlood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Assistant Professor

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 31, 2022

Study Start

March 15, 2024

Primary Completion

August 20, 2024

Study Completion

December 15, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations