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Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

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ClinicalTrials.gov Identifier: NCT04420819
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Franciele Marques Vanderle, Paulista University

Brief Summary:
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, muscle thickness by ultrasound 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.

Condition or disease Intervention/treatment Phase
Healthy Device: Ischemic Preconditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise: Randomized Clinical Trial Placebo Controlled
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPC-LOP
this group will carry out the baseline assessments, perform the ischemic preconditioning using exactly the limb occlusion pressure , then perform post-IPC assessments and start the excentric exercise, and the post-exercise assessments will take place immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.
Device: Ischemic Preconditioning
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

Experimental: IPC-40%
this group will carry out baseline assessments, perform IPC using 40% more occlusion than LOP, then perform assessments after IPC protocol and start EE, and post exercise assessments will take place immediately after the end of EE and will be repeated in 24h, 48h, 72h and 96h.
Device: Ischemic Preconditioning
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

Placebo Comparator: IPC-10mmHg:
this group will perform baseline assessments, perform occlusion-perfusion intervention with 10 mmHg restriction characterizing the placebo, then perform post-IPC assessments and initiate EE, and post-exercise assessments will take place immediately after completion of EE and if will repeat in 24h, 48h, 72h and 96h.
Device: Ischemic Preconditioning
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

No Intervention: CONTR
this group will carry out the baseline assessments, immediately after starting the EE, and the post-exercise assessments will happen immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.



Primary Outcome Measures :
  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. Evaluation of muscle structure using ultrasound using Siemens equipment [ Time Frame: Change from baseline at 96 hours after exercise ]
    Thickness in centimeters of the rectus femoris (RF) and vastus lateralis (VL) muscles.

  4. Muscle strength in isokinetic [ Time Frame: Change from baseline at 96 hours after exercise ]
    Maximal voluntary isometric contraction (MVIC)


Secondary Outcome Measures :
  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"



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420819


Contacts
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Contact: Franciele M Vanderlei, PhD +55 (18) 3229-5824 franmvanderlei@gmail.com
Contact: Eduardo Pizzo Junior, Ft eduardopizzojr@hotmail.com

Locations
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Brazil
Franciele Marques Vanderlei
Presidente Prudente, SP, Brazil, 55
Contact: Franciele M Vanderlei, PhD    +55 (18) 3229-5824    franmvanderlei@gmail.com   
Sponsors and Collaborators
Paulista University
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Responsible Party: Franciele Marques Vanderle, Principal Investigator, Paulista University
ClinicalTrials.gov Identifier: NCT04420819    
Other Study ID Numbers: FCT/UNESP
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franciele Marques Vanderle, Paulista University:
Ischemic Preconditioning
Exercise
Musculoskeletal Pain
Creatine Kinase
Muscle Fatigue
Stress, Physiological
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes