Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

NCT04420819 | Completed DMC

• 1 other identifier: FCT/UNESP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Ischemic Preconditioning; Exercise; Musculoskeletal Pain; Creatine Kinase; Muscle Fatigue; Stress, Physiological

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Muscle pain

  Change from baseline at 96 hours after exercise

• Pain threshold

  Change from baseline at 96 hours after exercise

• Resistance through Bioimpedance analysis (BIA)

  Change from baseline at 96 hours after exercise

• Reactance through Bioimpedance analysis (BIA)

  Change from baseline at 96 hours after exercise

• Phase angle through Bioimpedance analysis (BIA)

  Change from baseline at 96 hours after exercise

Study Arms (4)

IPC-LOP

EXPERIMENTAL

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

IPC-40%

EXPERIMENTAL

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

IPC-10mmHg:

PLACEBO COMPARATOR

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

CONTR

NO INTERVENTION

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.

Interventions

Ischemic Preconditioning 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:; IPC-40%; IPC-LOP

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paulista University: lead

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33952329 DERIVED

MeSH Terms

Conditions

Motor Activity; Musculoskeletal Pain

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)