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HealthyNCT04420819

Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise

A study testing Ischemic Preconditioning in people with Healthy, run by Paulista University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ischemic Preconditioning
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteBrazil
Study dates
1 Apr 2021to 1 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Franciele Marques Vanderlei

    Presidente Prudente, São Paulo, 55

Other trials in Brazil

About this study

Official title: 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.

Conditions
Healthy
Being tested
Ischemic Preconditioning
Keywords
Ischemic Preconditioning, Exercise, Musculoskeletal Pain, Creatine Kinase, Muscle Fatigue, Stress, Physiological
Medical subject headings
Motor Activity, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ischemic PreconditioningDevice

    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

Study groups in NCT04420819
Study groupRoleWhat they receive
IPC-LOPExperimentalthis 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.
Receives: Device: Ischemic Preconditioning
IPC-40%Experimentalthis 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.
Receives: Device: Ischemic Preconditioning
IPC-10mmHg:Placebo comparatorthis 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.
Receives: Device: Ischemic Preconditioning
CONTRNo interventionthis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle damage

    Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.

    Measured: Change from baseline at 96 hours after exercise

  2. Blood lactate concentration

    Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary

    Measured: Change from baseline at 96 hours after exercise

  3. Muscle strength in isokinetic

    Maximal voluntary isometric contraction (MVIC)

    Measured: Change from baseline at 96 hours after exercise

Secondary outcomes (9)

  1. Muscle pain

    Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.

    Measured: Change from baseline at 96 hours after exercise

  2. 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.

    Measured: Change from baseline at 96 hours after exercise

  3. Resistance through Bioimpedance analysis (BIA)

    Evaluation of tissue resistance, the higher the value, the worse the result

    Measured: Change from baseline at 96 hours after exercise

  4. Reactance through Bioimpedance analysis (BIA)

    Evaluation of tissue reactance, the higher the value, the better the cell integrity

    Measured: Change from baseline at 96 hours after exercise

  5. Phase angle through Bioimpedance analysis (BIA)

    Assessment of the phase angle, the higher the value, the better the condition of the participant

    Measured: Change from baseline at 96 hours after exercise

  6. Tone muscular through Myotonometry used the MyotonPRO equipment

    Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle

    Measured: Change from baseline at 96 hours after exercise

  7. Stiffness through Myotonometry used the MyotonPRO equipment

    Dynamic Stiffness [N/m] of the quadriceps femoris muscle

    Measured: Change from baseline at 96 hours after exercise

  8. Elasticity through Myotonometry used the MyotonPRO equipment

    Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle

    Measured: Change from baseline at 96 hours after exercise

  9. 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"

    Measured: Change from baseline at 96 hours after exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start1 Apr 2021
  3. Primary completion1 Dec 2021
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420819
Sponsor's protocol ID
FCT/UNESP
Status last verified
Apr 2022
First submitted
29 May 2020
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33952329

Questions about this trial

What is this clinical trial studying?

A study testing Ischemic Preconditioning in people with Healthy, run by Paulista University at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle damage (time frame: Change from baseline at 96 hours after exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.

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