Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Ischemic Preconditioning

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Presidente Prudente, SP, Brazil, 55
      • Franciele Marques Vanderlei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle damage	Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.	Change from baseline at 96 hours after exercise
Blood lactate concentration	Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary	Change from baseline at 96 hours after exercise
Muscle strength in isokinetic	Maximal voluntary isometric contraction (MVIC)	Change from baseline at 96 hours after exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle pain	Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.	Change from baseline at 96 hours after exercise
Pain threshold	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.	Change from baseline at 96 hours after exercise
Resistance through Bioimpedance analysis (BIA)	Evaluation of tissue resistance, the higher the value, the worse the result	Change from baseline at 96 hours after exercise
Reactance through Bioimpedance analysis (BIA)	Evaluation of tissue reactance, the higher the value, the better the cell integrity	Change from baseline at 96 hours after exercise
Phase angle through Bioimpedance analysis (BIA)	Assessment of the phase angle, the higher the value, the better the condition of the participant	Change from baseline at 96 hours after exercise
Tone muscular through Myotonometry used the MyotonPRO equipment	Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle	Change from baseline at 96 hours after exercise
Stiffness through Myotonometry used the MyotonPRO equipment	Dynamic Stiffness [N/m] of the quadriceps femoris muscle	Change from baseline at 96 hours after exercise
Elasticity through Myotonometry used the MyotonPRO equipment	Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle	Change from baseline at 96 hours after exercise
Perception of recovery	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"	Change from baseline at 96 hours after exercise

Collaborators and Investigators

• Sponsor: Paulista University

Publications and helpful links

General Publications

• Pizzo Junior E, de Souza Cavina AP, Lemos LK, Biral TM, Pastre CM, Vanderlei FM. Effects of different ischemic preconditioning occlusion pressures on muscle damage induced by eccentric exercise: a study protocol for a randomized controlled placebo clinical trial. Trials. 2021 May 5;22(1):326. doi: 10.1186/s13063-021-05285-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Musculoskeletal Pain; Creatine Kinase; Ischemic Preconditioning; Muscle Fatigue; Stress, Physiological
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: FCT/UNESP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No