Blood Flow Restriction and Low-Intensity Resistance TrainingNCT07299461
Blood Flow Restriction Training After Meniscus Surgery
A study testing Traditional physical therapy exercises and physical therapy modalities and Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE) in people with Blood Flow Restriction and Low-Intensity Resistance Training and Meniscal Injuries, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Blood Flow Restriction and Low-Intensity Resistance Training, Meniscal Injuries
- What is being tested?
- Traditional physical therapy exercises and physical therapy modalities and Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of Diabetes Mellitus
- Having skin sensitivity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Traditional physical therapy exercises and physical therapy modalities, Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE)
- Keywords
- meniscus, knee pain, Blood Flow Restriction, exercise, physiotherapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapy exercises and physical therapy modalitiesOther
- 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.
Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm ( traditional treatment ) | Active comparator | 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. Receives: Other: Traditional physical therapy exercises and physical therapy modalities |
| Treatment Group ( traditional treatment + BFR-LIRE exercises treatment ) | Experimental | 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. Receives: Other: Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: Baseline and after 8 weeks of intervention
Tampa Scale for Kinesiophobia (TSK)
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."
Measured: Baseline and after 8 weeks of intervention
Assessment of Range of Motion
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.
Measured: Baseline and after 8 weeks of intervention
Muscle Strength Analysis
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.
Measured: Baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start3 Jun 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction and Low-Intensity Resistance TrainingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Muhammed Fatih Kavak, Uskudar University
- Investigators
- Muhammed Fatih Kavak, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299461
- Sponsor's protocol ID
- MFKAVAK-UUTEZ 01
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07299461
- Acronym / sponsor ID
- MFKAVAK-UUTEZ 01
- Keywords
- meniscus, knee pain, Blood Flow Restriction, exercise, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 23 Dec 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm ( traditional treatment ) | Active comparator | Other: Traditional physical therapy exercises and physical therapy modalitiesThe 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. |
| Treatment Group ( traditional treatment + BFR-LIRE exercises treatment ) | Experimental | Other: Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| 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. | Other | Control Arm ( traditional treatment ) |
| 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. | Other | Treatment Group ( traditional treatment + BFR-LIRE exercises treatment ) |
Primary outcome
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.
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."
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. Study Protocol
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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. This study is not recruiting at the moment.
Muhammed Fatih Kavak study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical therapy exercises and physical therapy modalities and Traditional physical therapy exercises and physical therapy modalities + low-intensity resistance exercise with blood flow restriction (BFR-LIRE) in people with Blood Flow Restriction and Low-Intensity Resistance Training and Meniscal Injuries, run by Uskudar University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 23 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline and after 8 weeks of intervention). The study lists 4 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 23 Dec 2025.