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Completed

NCT Number: NCT04420819

Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

Introduction: eccentric exercise (EE) has been widely used in rehabilitation and in improving physical fitness due to its mechanical advantage and less metabolic demand, however, EE can induce muscle damage providing structural changes and reduced muscle function, therefore, it is necessary to look for alternatives to reduce this damage caused by stress. Thus, ischemic preconditioning (PCI) can be seen as an aid in reducing the damage caused by EE, as it can attenuate the ischemia-reperfusion injury, and can be used to accelerate the post-exercise recovery process. Objectives: to compare the effects of PCI, using different occlusion pressures, on acute and late responses to perceptual outcomes and muscle injury markers, in addition to checking whether the technique causes deleterious effects on performance in post-exercise recovery. Methods: a randomized placebo controlled clinical trial will be conducted with 80 healthy men aged 18 to 35 years who will be randomly divided into four groups: PCI using total occlusion pressure (POT), PCI with 40% more than POT, placebo (10 mmHg) and control. The PCI protocol will consist of four cycles of ischemia and reperfusion of five minutes each. All groups will perform an EE protocol, initial assessments, immediately after the end of the EE, 24, 48, 72 and 96 hours after exercise, with the maximum isometric voluntary contraction (CVIM) assessed by the isokinetic dynamometer, vectors of cell integrity by by means of electrical bioimpedance (BIA), creatine kinase (CK), blood lactate, pain on the visual analog scale (VAS), pain threshold by the pressure algometer, and tone, muscle rigidity and elasticity by myotonometry. The descriptive statistical method and analysis of variance will be used for the repeated measures model. The level of significance will be p <0.05.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • not having any health condition that contraindicates or prevents EE;
  • not having diagnosed diabetes and high blood pressure;
  • not having inflammatory, psychiatric, cardiovascular and / or respiratory rheumatic disease;
  • not being an alcoholic, using drugs and / or a smoker;
  • without a history of knee surgery (for example, meniscal repair and ligament reconstruction) or recent musculoskeletal injury to the lower limbs that may impair performance during tests or interventions (for example, muscle injury, tendinopathy, patellofemoral pain in the lower limbs and / or back pain in the last six months);
  • without involvement in any type of training program during the study period;
  • not being engaged in the lower limb strength training program during the three months prior to participating in the study;
  • not using ergogenic supplements to improve physical performance and / or muscle mass and / or vasoactive drugs;
  • not having one or more risk factors predisposing to thromboembolism.

Exclusion criteria

  • present a health problem that does not allow continuity,
  • use medication, electrotherapy or other therapeutic means that may interfere with any result;
  • perform unusual or strenuous physical activities during the evaluation period;
  • want to leave the study.

Treatment and study plan

Ischemic Preconditioning

Device

The IPC is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff

Primary outcomes

  1. Muscle damage

    Time frame: Change from baseline at 96 hours after exercise

    Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.

  2. Blood lactate concentration

    Time frame: Change from baseline at 96 hours after exercise

    Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary

  3. Muscle strength in isokinetic

    Time frame: Change from baseline at 96 hours after exercise

    Maximal voluntary isometric contraction (MVIC)

Secondary outcomes

  1. Muscle pain

    Time frame: Change from baseline at 96 hours after exercise

    Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.

  2. Pain threshold

    Time frame: Change from baseline at 96 hours after exercise

    Assessed using pressure algometer equipment, and the pain threshold will be classified according to the cut-off point of 2.55kgf. Participants will be classified as "sensitive to pain" if they have values below 2.55kgf.

  3. Resistance through Bioimpedance analysis (BIA)

    Time frame: Change from baseline at 96 hours after exercise

    Evaluation of tissue resistance, the higher the value, the worse the result

  4. Reactance through Bioimpedance analysis (BIA)

    Time frame: Change from baseline at 96 hours after exercise

    Evaluation of tissue reactance, the higher the value, the better the cell integrity

  5. Phase angle through Bioimpedance analysis (BIA)

    Time frame: Change from baseline at 96 hours after exercise

    Assessment of the phase angle, the higher the value, the better the condition of the participant

  6. Tone muscular through Myotonometry used the MyotonPRO equipment

    Time frame: Change from baseline at 96 hours after exercise

    Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle

  7. Stiffness through Myotonometry used the MyotonPRO equipment

    Time frame: Change from baseline at 96 hours after exercise

    Dynamic Stiffness [N/m] of the quadriceps femoris muscle

  8. Elasticity through Myotonometry used the MyotonPRO equipment

    Time frame: Change from baseline at 96 hours after exercise

    Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle

  9. Perception of recovery

    Time frame: Change from baseline at 96 hours after exercise

    Perception of recovery was obtained using a 10-point Likert Scale, with a rating of 1 indicating the feeling "not recovered" and a rating of 10 the feeling "fully recovered"

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Registry information

Official study title

Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise: Randomized Clinical Trial Placebo Controlled

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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