- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342634
Effect of Blood Flow Restriction on Recovery After Maximal Resistance Exercise
Effect of Blood Flow Restriction on Recovery After Maximal Resistance Exercise: a Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized clinical trial will be conducted with 40 men and 40 women allocated to one of four groups: i) BFR using 80% of total occlusion pressure (TOP) [BFR-80%]; ii) BFR using 60% of total occlusion pressure (TOP) [BFR-60%]; iii) BFR using 10 mmHg (BFR-10 mmHg); and iv) control (CON). All groups will undergo initial assessments, followed by the muscle stress protocol, and all outcomes will be collected again. Subsequently, the intervention to which they were previously randomized will be performed, and finally, subsequent assessments will be conducted immediately, 24, 48, and 72 hours after exercise. The outcomes assessed will be, in order: pain using the Numerical Rating Scale (NRS), perception of recovery and discomfort using the Likert scale, and perception of effort using the Borg scale (CR-10), cellular integrity vectors using bioelectrical impedance analysis (BIA), pain threshold using a pressure algometer, muscle tone, stiffness, and elasticity using myotonometry, quadriceps muscle strength test using a digital dynamometer, muscle power test using the Squat Jump test, and a single-leg jump functional test.
Participants will be duly informed about the procedures and objectives of this study, and after agreeing, will sign a free and informed consent form, thus becoming effectively part of it. In the consent form, participants will be asked if they agree to the use of their data should they choose to withdraw from the study. Participants will also be asked for permission for the research team to share relevant data with people from the universities participating in the research or regulatory authorities, when relevant, while preserving the participant's identity. The study will be submitted for review and approval to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil and will be registered on ClinicalTrials.gov.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Franciele Marques Vanderlei PhD
- Phone Number: +55 (18) 3229-5824
- Email: franmvanderlei@gmail.com
Study Locations
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil, 19060-900
- Recruiting
- Franciele Marques Vanderlei
-
Contact:
- Franciele M Vanderlei
- Phone Number: +55 (18) 3229-5824
- Email: franmvanderlei@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals exhibiting one or more of the following characteristics will not be included:
- (1) diabetes and hypertension;
- (2) inflammatory rheumatological, psychiatric, cardiovascular and/or respiratory disease;
- (3) pre-existing injury restricting their ability to perform vigorous physical activities;
- (4) having one or more predisposing risk factors for thromboembolism.
Exclusion Criteria:
- Participants will be excluded from the study if they:
- (1) have a health problem that does not allow them to continue;
- (2) wish to leave the study;
- (3) use medications, electrotherapy, or other therapeutic methods during the study period that could interfere with any results;
- (4) not sign the consent form.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood flow restriction with 80% occlusion
Will perform an BFR intervention using 80% of the total occlusion pressure (TOP) continuously for 20 minutes.
|
Will perform the intervention with BFR using 80% of the total occlusion pressure (TOP) continuously for 20 minutes.
|
|
Experimental: Blood flow restriction with 60% occlusion
Will perform an BFR intervention using 60% of the total occlusion pressure (TOP) continuously for 20 minutes.
|
Will perform the intervention with BFR using 60% of the total occlusion pressure (TOP) continuously for 20 minutes.
|
|
Placebo Comparator: Blood flow restriction with 10 mmHg of occlusion pressure
The intervention will be performed with BFR using 10 mmHg of occlusion pressure continuously for 20 minutes.
|
Will perform the intervention with BFR using 10 mmHg of occlusion pressure continuously for 20 minutes.
|
|
No Intervention: Control
It will remain at rest for 20 minutes without using BFR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower limb muscle power
Time Frame: Change from baseline at 72 hours after exercise
|
Muscle power will be assessed through the Squat Jump test using a contact platform (Multisprint).
Participants will begin in a 90° knee flexion position (verified with a goniometer), with hands on hips, and will perform a vertical jump without countermovement.
Variables to be analyzed will include jump height, modified reactive strength index, jump power, and take-off moment.
|
Change from baseline at 72 hours after exercise
|
|
Lower limb muscle function
Time Frame: Change from baseline at 72 hours after exercise
|
Muscle function will be assessed through the single leg hop functional test sing a measuring tape in centimeters.
The participant will be positioned standing on a flat surface, barefoot, and with their hands on their waist.
They will be asked to perform a horizontal jump with the greatest possible reach using only one lower limb (test performed unilaterally).
The contralateral limb will remain flexed without touching the ground during the execution.
After the jump, the participant must maintain balance for at least two seconds without losing stability or moving the landing foot.
The jump distance will be measured in centimeters from the toe of the supporting foot (before the jump) to the heel at the moment of landing, using a measuring tape.
|
Change from baseline at 72 hours after exercise
|
|
Isometric strenght of quadriceps and hamstring muscle
Time Frame: Change from baseline at 72 hours after exercise
|
The isometric peak torque of the quadriceps and hamstring will be measured using a digital handheld dynamometer (DD-300, Instrutherm).
For the quadriceps strength assessment, the participant will be seated in a chair with their knee bent at 90° and instructed to push maximally against the dynamometer.
To measure hamstring strength, the participant will be positioned in a prone position with their knee flexed at 90º and will be instructed to push maximally against the dynamometer.
Three attempts will be performed with a 1-minute rest interval.
The highest value will be used for analysis.
|
Change from baseline at 72 hours after exercise
|
|
Muscle soreness and pain threshold
Time Frame: Change from baseline at 72 hours after exercise
|
Muscle soreness will be assessed using a Numeric Pain Rating Scale (0-10).
Pain threshold will be measured with a pressure algometer (FPX 50/220; Wagner) at four sites: biceps femoris and rectus femoris.
Measurements will be recorded in kgf and will not exceed 2.55 kgf.
|
Change from baseline at 72 hours after exercise
|
|
Perceived exertion, recovery, and discomfort
Time Frame: Change from baseline at 72 hours after exercise
|
Perceived exertion, recovery, and discomfort will be measured using the Borg CR-10 scale (0-10).
Participants will rate: (1) exertion as whole-body effort, (2) discomfort as muscular sensations in the lower limbs, and (3) recovery as general physical and psychological recovery.
Values will be individually recorded at each time point.
|
Change from baseline at 72 hours after exercise
|
|
Myotonometry
Time Frame: Change from baseline at 72 hours after exercise
|
Muscle tone, stiffness, and elasticity will be measured using the MyotonPRO device.
The probe will be positioned perpendicularly over the following sites: biceps femoris and rectus femoris.
The device will apply a 0.18 N pre-load and a 0.40 N impulse to induce tissue oscillation for measurement.
|
Change from baseline at 72 hours after exercise
|
|
Bioelectrical impedance analysis
Time Frame: Change from baseline at 72 hours after exercise
|
Bioimpedance will be measured using a tetrapolar device (BIA Analyzer, 50 kHz, 800 µA).
Electrodes will be positioned on the biceps femoris and rectus femoris.
Analyzed variables will include resistance (R), reactance (Xc), phase angle (PhA), and tolerance ellipse, via Bioscan software.
|
Change from baseline at 72 hours after exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occlusion pressures (AOP)
Time Frame: Baseline
|
To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the posterior tibial artery to capture the auscultatory pulse.
A blood pressure cuff will be fixed to the participant's thigh close to the region of the inguinal fold of the dominant limb, and then with the inflatable region of the cuff on the medial portion of the thigh covering the femoral artery, it will be progressively inflated, waiting 15 seconds every 30 mmHg until the point at which the auscultatory pulse of the tibial artery is interrupted.
|
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 91529125.6.0000.5402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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