Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

NCT ID: NCT04420819

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-04-01

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, 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ischemic Preconditioning

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Ischemic Preconditioning

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Ischemic Preconditioning

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Paulista University

OTHER

Sponsor Role: lead

Responsible Party

Franciele Marques Vanderle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33952329 (View on PubMed)

Other Identifiers

FCT/UNESP

Identifier Type: -

Identifier Source: org_study_id