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Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Ischemic Preconditioning, Exercise, Musculoskeletal Pain, Creatine Kinase, Muscle Fatigue, Stress, Physiological

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Franciele Marques Vanderlei

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

No Intervention

Arm Label

IPC-LOP

IPC-40%

IPC-10mmHg:

CONTR

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Muscle damage
Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.
Blood lactate concentration
Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary
Muscle strength in isokinetic
Maximal voluntary isometric contraction (MVIC)

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2020
Last Updated
April 19, 2022
Sponsor
Paulista University
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1. Study Identification

Unique Protocol Identification Number
NCT04420819
Brief Title
Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise
Official Title
Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise: Randomized Clinical Trial Placebo Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Ischemic Preconditioning, Exercise, Musculoskeletal Pain, Creatine Kinase, Muscle Fatigue, Stress, Physiological

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPC-LOP
Arm Type
Experimental
Arm Description
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.
Arm Title
IPC-40%
Arm Type
Experimental
Arm Description
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.
Arm Title
IPC-10mmHg:
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
CONTR
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ischemic Preconditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Muscle damage
Description
Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.
Time Frame
Change from baseline at 96 hours after exercise
Title
Blood lactate concentration
Description
Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary
Time Frame
Change from baseline at 96 hours after exercise
Title
Muscle strength in isokinetic
Description
Maximal voluntary isometric contraction (MVIC)
Time Frame
Change from baseline at 96 hours after exercise
Secondary Outcome Measure Information:
Title
Muscle pain
Description
Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.
Time Frame
Change from baseline at 96 hours after exercise
Title
Pain threshold
Description
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.
Time Frame
Change from baseline at 96 hours after exercise
Title
Resistance through Bioimpedance analysis (BIA)
Description
Evaluation of tissue resistance, the higher the value, the worse the result
Time Frame
Change from baseline at 96 hours after exercise
Title
Reactance through Bioimpedance analysis (BIA)
Description
Evaluation of tissue reactance, the higher the value, the better the cell integrity
Time Frame
Change from baseline at 96 hours after exercise
Title
Phase angle through Bioimpedance analysis (BIA)
Description
Assessment of the phase angle, the higher the value, the better the condition of the participant
Time Frame
Change from baseline at 96 hours after exercise
Title
Tone muscular through Myotonometry used the MyotonPRO equipment
Description
Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle
Time Frame
Change from baseline at 96 hours after exercise
Title
Stiffness through Myotonometry used the MyotonPRO equipment
Description
Dynamic Stiffness [N/m] of the quadriceps femoris muscle
Time Frame
Change from baseline at 96 hours after exercise
Title
Elasticity through Myotonometry used the MyotonPRO equipment
Description
Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle
Time Frame
Change from baseline at 96 hours after exercise
Title
Perception of recovery
Description
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"
Time Frame
Change from baseline at 96 hours after exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Franciele Marques Vanderlei
City
Presidente Prudente
State/Province
SP
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33952329
Citation
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.
Results Reference
derived

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Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

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