Recovery MethodsNCT06949995
Effects of Blood Flow Restriction on Post-Exercise Recovery in Amateur Runners
A study testing Active Recovery with Blood Flow Restriction and Active Recovery in people with Recovery Methods and Recovery Time, run by Paulista University at 1 site in Brazil.
Trial summary
Street running has become an increasingly popular sport. As a result, effective recovery strategies after exercise are essential. In this context, two techniques stand out: one already validated, active recovery (AR), and another with potential, blood flow restriction (BFR). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Recovery Methods, Recovery Time
- What is being tested?
- Active Recovery with Blood Flow Restriction and Active Recovery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Franciele Marques Vanderlei
Presidente Prudente, São Paulo, 19060-900
Franciele M M Vanderlei, PhD, +55 (18) 3229-5824, franmvanderlei@gmail.com
About this study
Official title: Effects of Blood Flow Restriction on Post-Exercise Recovery in Amateur Runners: A Stratified Randomized Controlled Trial
Street running has become an increasingly popular sport. As a result, effective recovery strategies after exercise are essential. In this context, two techniques stand out: one already validated, active recovery (AR), and another with potential, blood flow restriction (BFR). This study aims to investigate whether using both techniques simultaneously can benefit practitioners and improve outcomes compared to complete rest.
Read the 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.
- Conditions
- Recovery Methods, Recovery Time
- Being tested
- Active Recovery with Blood Flow Restriction, Active Recovery
- Keywords
- Running, physiological stress, functional physical performance, post-exercise recovery techniques, blood flow restriction therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Recovery with Blood Flow RestrictionDevice
10-minute active recovery protocol performed with blood flow restriction using a pneumatic cuff set at 60% of the participant's total occlusion pressure.
Active RecoveryOther
10-minute active recovery protocol.
| Study group | Role | What they receive |
|---|---|---|
| Active Recovery and Blood Flow Restriction | Experimental | 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 Receives: Device: Active Recovery with Blood Flow Restriction |
| Active Recovery | Active comparator | 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. Receives: Other: Active Recovery |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Isometric strength of the triceps surae
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.
Measured: Change from baseline at 96 hours after exercise
Aerobic capacity
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).
Measured: Change from baseline at 96 hours after exercise
Lower limb muscle power
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.
Measured: Change from baseline at 96 hours after exercise
Muscle soreness and pain threshold
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.
Measured: Change from baseline at 96 hours after exercise
Perceived exertion, recovery, and discomfort
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.
Measured: Change from baseline at 96 hours after exercise
Myotonometry
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.
Measured: Change from baseline at 96 hours after exercise
Bioelectrical impedance analysis
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.
Measured: Change from baseline at 96 hours after exercise
Heart rate variability (HRV)
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.
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.
- First posted29 Apr 2025
- Study start27 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949995
- Sponsor's protocol ID
- 84324824.9.0000.5402
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction on Post-Exercise Recovery in Amateur Runners: A Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06949995
- Acronym / sponsor ID
- 84324824.9.0000.5402
- Conditions
- Recovery Methods, Recovery Time
- Keywords
- Running, physiological stress, functional physical performance, post-exercise recovery techniques, blood flow restriction therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Street running has become an increasingly popular sport. As a result, effective recovery strategies after exercise are essential. In this context, two techniques stand out: one already validated, active recovery (AR), and another with potential, blood flow restriction (BFR). This study aims to investigate whether using both techniques simultaneously can benefit practitioners and improve outcomes compared to complete rest.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Recovery and Blood Flow Restriction | Experimental | Device: Active Recovery with Blood Flow RestrictionParticipants 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 |
| Active Recovery | Active comparator | Other: Active RecoveryParticipants will undergo baseline assessments, followed by a muscle stress protocol. After that, they will perform 10 minutes of active recovery (AR) without any restriction. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Recovery with Blood Flow Restriction10-minute active recovery protocol performed with blood flow restriction using a pneumatic cuff set at 60% of the participant's total occlusion pressure. | Device | Active Recovery and Blood Flow Restriction |
| Active Recovery10-minute active recovery protocol. | Other | Active Recovery |
Primary outcome
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.
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).
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.
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.
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.
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.
Bioelectrical impedance analysis
Time frame: Change from baseline at 96 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, rectus femoris, tibialis anterior, and gastrocnemius. Analyzed variables will include resistance (R), reactance (Xc), phase angle (PhA), and tolerance ellipse, via Bioscan software.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Recovery with Blood Flow Restriction and Active Recovery in people with Recovery Methods and Recovery Time, 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 7 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franciele Marques Vanderlei, PhD (+55 (18) 3229-5824, franmvanderlei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric strength of the triceps surae (time frame: Change from baseline at 96 hours after exercise). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.