Blood Flow Restriction Training After Meniscus Surgery

December 9, 2025 updated by: Dr. Öğr. Üyesi Muhammed Fatih Kavak, Uskudar University

Investigation of the Effects of Combined Low-intensity Resistance Exercise With Blood Flow Restriction on Muscle Strength, Pain, and Fear of Movement in Post-operative Meniscus Rehabilitation

This study was conducted to investigate the effects of combined low-intensity resistance exercise with blood flow restriction (BFR-LIRE) on muscle strength, pain, and fear of movement in individuals who had undergone post-operative meniscus surgery.

A total of 36 individuals who reported knee pain of 4 or higher on the Visual Analog Scale (VAS) following surgery voluntarily participated in the study. The participants were randomly divided into two groups. The first group underwent traditional physical therapy exercises and physical therapy modalities for the operated lower extremity for 60 minutes a day, three days a week, for eight weeks. The second group received the same traditional physical therapy modalities and exercises for 60 minutes a day, three days a week, for eight weeks, with an additional 15-minute BFR-LIRE session aimed at increasing the strength of the operated lower extremity and managing pain.

Keywords: Pain, Knee Pain, Meniscus, Physiotherapy, Blood Flow Restriction, Exercise

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ümraniye
      • Istanbul, Ümraniye, Turkey (Türkiye), 34768
        • Uskudar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having undergone meniscus repair surgery within the last 6 months
  • Being between 20 and 50 years of age
  • Being unable to perform high-intensity training
  • Having a Visual Analog Scale (VAS) score of 4 or higher

Exclusion Criteria:

  • Having a history of hypertension
  • Having a history of heart failure or myocardial infarction
  • Having a history of Deep Vein Thrombosis (DVT)
  • Having Peripheral Artery Disease, varicose veins, or bleeding disorders
  • Use of anticoagulants
  • Presence or history of peripheral nerve disorders or neuropathy
  • History of Diabetes Mellitus
  • Having skin sensitivity
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Arm ( traditional treatment )
The first group underwent traditional physical therapy exercises and physical therapy modalities for the operated lower extremity for 60 minutes a day, three days a week, for eight weeks.
Other: Traditional physical therapy exercises and physical therapy modalities
  • NMES for 20 minutes
  • Therapeutic (Continuous) Ultrasound for 6 minutes
  • Cold Pack (CP) for 7 minutes
  • Conventional Physical Therapy Exercises:

Stretching exercises targeting the quadriceps femoris, hamstrings, and gastrocnemius muscles were performed by the patient for 30 seconds of stretching followed by 30 seconds of rest, for a total of 3 sets. All stretching movements were supervised by a physiotherapist, and each stretch was performed up to the patient's pain threshold.
Experimental: Treatment Group ( traditional treatment + BFR-LIRE exercises treatment )
The second group received the same traditional physical therapy modalities and exercises for 60 minutes a day, three days a week, for eight weeks, with an additional 15-minute BFR-LIRE session aimed at increasing the strength of the operated lower extremity and managing pain.
Other: Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE)
In addition to the other intervention group procedures, a 15-minute low-intensity resistance exercise program with BFR-which is known to be effective in increasing muscle strength despite being performed at low intensity-was included in the patients' treatment protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Baseline and after 8 weeks of intervention
The Visual Analog Scale (VAS) was used to measure the severity of pain felt by the patients in the knee region before and after treatment. VAS is an assessment tool that was first developed in the field of psychology and later began to be used in pharmacology to evaluate pain in rheumatology patients undergoing treatment. Patients are asked to mark the point that indicates their pain intensity on a 100 mm (10-centimeter) scale. An increase in the value indicates that the perceived pain intensity has increased. VAS is a scale that can be administered in a very short time and has high reliability.
Baseline and after 8 weeks of intervention
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline and after 8 weeks of intervention
The Tampa Scale for Kinesiophobia (TSK), which is frequently used to assess fear of movement related to pain in individuals with chronic musculoskeletal pain, was preferred in this study to evaluate participants' levels of fear and avoidance associated with movement. The Turkish validity and reliability study of the scale has been conducted. The scale consists of 17 items scored on a Likert scale. Individuals can obtain a score between 17 and 68, and higher scores indicate a greater level of kinesiophobia. Participants were asked to complete the scale themselves by selecting one of the following options for each item: "strongly disagree," "disagree," "agree," or "strongly agree."
Baseline and after 8 weeks of intervention
Assessment of Range of Motion
Time Frame: Baseline and after 8 weeks of intervention
While measuring knee flexion and extension angles, patients were positioned supine as recommended by Clarkson et al. In measurements performed using a universal goniometer, the pivot point was placed on the lateral condyle of the femur, the stationary arm was aligned with the lateral midline of the femur, and the movable arm was aligned parallel to the fibula.
Baseline and after 8 weeks of intervention
Muscle Strength Analysis
Time Frame: Baseline and after 8 weeks of intervention
Muscle strength measurements were performed using a digital hand-held dynamometer, the "MicroFET2" (Hoggan Health Industries, Draper, UT), which has been shown to be valid and reliable in many studies. Knee extension (quadriceps) muscle strength, knee flexion (hamstring) muscle strength, and ankle plantar flexion (gastrocnemius) muscle strength were measured in accordance with the procedures described in the validity and reliability studies of the MicroFET2 device.
Baseline and after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Muhammed Fatih Kavak, Uskudar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MFKAVAK-UUTEZ 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

09.12.2025-09.12.2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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