- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949995
Effects of Blood Flow Restriction on Post-Exercise Recovery in Amateur Runners
Effects of Blood Flow Restriction on Post-Exercise Recovery in Amateur Runners: A Stratified Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial aims to evaluate the effects of combining active recovery (AR) and blood flow restriction (BFR) on post-exercise recovery in amateur runners. Thirty-four healthy male participants aged 18-40 years, who run at a pace faster than 5:30 min/km, will be stratified based on their performance in the 3-minute all-out running test and randomly assigned to one of three groups: AR with BFR, AR alone, or passive rest (control). All participants will undergo baseline assessments, followed by a muscle stress protocol, the assigned recovery strategy, and follow-up evaluations immediately, and at 24, 48, 72, and 96 hours post-exercise.
Outcomes include heart rate variability (via RR intervals), muscle soreness (Numeric Rating Scale), recovery perception and discomfort (Likert scale), effort (Borg CR-10), cellular integrity (bioelectrical impedance), pain threshold (pressure algometer), muscle tone, stiffness, and elasticity (myotonometry), muscle power (Squat Jump test), plantar flexor strength (digital dynamometer), and maximal aerobic capacity (3-minute test). Data will be analyzed using descriptive statistics and repeated measures ANOVA, with significance set at p<0.05.
Participants will be duly informed about the procedures and objectives of this study, and after agreeing, they will sign an informed consent form, effectively becoming part of it. In the consent form, participants will be asked if they agree to the use of their data if they choose to withdraw from the study. Participants will also be asked for permission for the research team to share relevant data with people at universities participating in the research or regulatory authorities, where relevant. The study will be sent for consideration and approval to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.
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
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Presidente Prudente, São Paulo, Brazil, 19060-900
- Recruiting
- Franciele Marques Vanderlei
-
Contact:
- Franciele M M Vanderlei, PhD
- 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 who present one or more of the following characteristics will not be included:
- 1 presence of any health condition that contraindicates or prevents exercise;
- 2 diabetes and diagnosed high blood pressure;
- 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;
- 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent lower limb musculoskeletal injury that may impair performance during tests or interventions (e.g., muscle injury, tendinopathy, patellofemoral pain and/or back pain column in the last six months);
- 6 use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications;
- 7 having one or more risk factors predisposing to 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 not sign the consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Recovery and Blood Flow Restriction
Participants will undergo baseline assessments, followed by a muscle stress protocol.
After that, they will perform 10 minutes of active recovery (AR) using a blood flow restriction cuff at 60% of total occlusion pressure
|
10-minute active recovery protocol performed with blood flow restriction using a pneumatic cuff set at 60% of the participant's total occlusion pressure.
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|
Active Comparator: Active Recovery
Participants will undergo baseline assessments, followed by a muscle stress protocol.
After that, they will perform 10 minutes of active recovery (AR) without any restriction.
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10-minute active recovery protocol.
|
|
No Intervention: Control
Participants will undergo baseline assessments, followed by a muscle stress protocol.
After that, they will undergo 10 minutes of absolute rest, without any movement or intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric strength of the triceps surae
Time Frame: Change from baseline at 96 hours after exercise
|
The isometric peak torque of the triceps surae will be measured using a digital handheld dynamometer (DD-300, Instrutherm).
Participants will lie in a prone position with the knee flexed at 90°, foot dorsiflexed, 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 96 hours after exercise
|
|
Aerobic capacity
Time Frame: Change from baseline at 96 hours after exercise
|
Aerobic capacity will be evaluated using a 3-minute all-out running test (TM3) on a non-motorized treadmill.
After a 5-minute warm-up at 7 km/h, participants will run at maximal effort for 3 minutes.
Power and velocity outputs will be recorded by the treadmill's sensors and used to calculate critical power (CP) and critical velocity (CV).
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Change from baseline at 96 hours after exercise
|
|
Lower limb muscle power
Time Frame: Change from baseline at 96 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.
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Change from baseline at 96 hours after exercise
|
|
Muscle soreness and pain threshold
Time Frame: Change from baseline at 96 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, rectus femoris, tibialis anterior, and gastrocnemius.
Measurements will be recorded in kgf and will not exceed 2.55 kgf.
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Change from baseline at 96 hours after exercise
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Perceived exertion, recovery, and discomfort
Time Frame: Change from baseline at 96 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.
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Change from baseline at 96 hours after exercise
|
|
Myotonometry
Time Frame: Change from baseline at 96 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, rectus femoris, tibialis anterior, and gastrocnemius.
The device will apply a 0.18 N pre-load and a 0.40 N impulse to induce tissue oscillation for measurement.
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Change from baseline at 96 hours after exercise
|
|
Bioelectrical impedance analysis
Time Frame: Change from baseline at 96 hours after exercise
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Bioimpedance will be measured using a tetrapolar device (BIA Analyzer, 50 kHz, 800 µA).
Electrodes will be positioned on the biceps femoris, rectus femoris, tibialis anterior, and gastrocnemius.
Analyzed variables will include resistance (R), reactance (Xc), phase angle (PhA), and tolerance ellipse, via Bioscan software.
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Change from baseline at 96 hours after exercise
|
|
Heart rate variability (HRV)
Time Frame: Change from baseline at 96 hours after exercise
|
HRV will be assessed using a validated monitor (Polar V800).
RR intervals will be collected at rest (10 minutes), during a 10-km run, and post-intervention (60 minutes).
On other days, collections will last 20 minutes.
Participants will be instructed to avoid stimulants during data collection.
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Change from baseline at 96 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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- 84324824.9.0000.5402
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
product manufactured in and exported from the U.S.
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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