NCT06949995

Brief 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). This study aims to investigate whether using both techniques simultaneously can benefit practitioners and improve outcomes compared to complete rest.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 9, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Runningphysiological stressfunctional physical performancepost-exercise recovery techniquesblood flow restriction therapy

Outcome Measures

Primary Outcomes (8)

  • 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.

    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).

    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.

    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.

    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.

    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.

    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.

    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.

    Change from baseline at 96 hours after exercise

Other Outcomes (1)

  • Occlusion pressures (AOP)

    Baseline

Study Arms (3)

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

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.

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.

Interventions

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 Recovery and Blood Flow Restriction

10-minute active recovery protocol.

Active Recovery

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals assigned male at birth will be included, due to physiological characteristics relevant to the study objectives.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who present one or more of the following characteristics will not be included:
  • presence of any health condition that contraindicates or prevents exercise;
  • diabetes and diagnosed high blood pressure;
  • inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;
  • 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);
  • use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications;
  • having one or more risk factors predisposing to thromboembolism

You may not qualify if:

  • Participants will be excluded from the study if they:
  • have a health problem that does not allow them to continue;
  • wish to leave the study;
  • not sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 29, 2025

Study Start

April 22, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations