Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420819
• Other study ID #: FCT/UNESP
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Paulista University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Ischemia

Intervention

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

Locations

Country	Name	City	State
Brazil	Franciele Marques Vanderlei	Presidente Prudente	SP

Sponsors (1)

Lead Sponsor	Collaborator
Paulista University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Muscle strength in isokinetic	Maximal voluntary isometric contraction (MVIC)	Change from baseline at 96 hours after exercise
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stiffness through Myotonometry used the MyotonPRO equipment	Dynamic Stiffness [N/m] of the quadriceps femoris muscle	Change from baseline at 96 hours after exercise
Secondary	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
Secondary	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