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

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

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
Contact: Franciele M Vanderlei, PhD | +55 (18) 3229-5824 | franmvanderlei@gmail.com | |
Contact: Eduardo Pizzo Junior, Ft | eduardopizzojr@hotmail.com |
Brazil | |
Franciele Marques Vanderlei | |
Presidente Prudente, SP, Brazil, 55 | |
Contact: Franciele M Vanderlei, PhD +55 (18) 3229-5824 franmvanderlei@gmail.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ischemic Preconditioning Exercise Musculoskeletal Pain |
Creatine Kinase Muscle Fatigue Stress, Physiological |
Ischemia Pathologic Processes |