Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome
NCT ID: NCT06565754
Last Updated: 2024-08-22
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-09-01
2026-04-01
Brief Summary
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Detailed Description
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Purpose: This study aims to compare the efficacy of combining BFRT with traditional strengthening exercises versus using strengthening exercises alone in improving muscular strength, pain, function, joint position sense, and dynamic balance in patients with PFPS.
Methods: A triple-blinded, randomized controlled trial was conducted at the Almenshawy General Hospital, Tanta, Egypt. Fifty patients with unilateral non-traumatic PFPS, aged 18-35, were randomly assigned to either a strengthening exercises group (SE Group) or a BFRT plus strengthening exercises group (BFRT Group). Both groups underwent a 6-week intervention with three sessions per week. Outcomes assessed included quadriceps and hip abductors strength, pain severity (Visual Analog Scale), functional status (Kujala Patellofemoral Score), joint position sense (measured by digital inclinometer), and dynamic balance (Star Excursion Balance Test).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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strengthening exercises group (SE Group)
all patients will receive :
1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s).
2. Straight leg raise (SLR) with 3 sets - 20 repetitions.
3. Short arc knee extension exercise - 3 sets of 20 repetitions.
4. Hip abduction from side lying - 3 sets of 20 repetitions.
strengthening exercise
Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).
BFRT plus strengthening exercises group (BFRT Group)
all patients will receive the below exercises using BFR cuff :
1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s).
2. Straight leg raise (SLR) with 3 sets - 20 repetitions.
3. Short arc knee extension exercise - 3 sets of 20 repetitions.
4. Hip abduction from side lying - 3 sets of 20 repetitions.
BFR
Blood flow restriction training is an accessory to a variety of different exercise modes (e.g., resistance exercise, walking, cycling) has recently become a popular research topic. It involves the application of pressurized cuffs to the proximal portion of each lower extremity or upper extremity. It enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet or cuff.
The 3rd Generation SmartCuffs® pump (SmartCuffs® 3.0 PRO) is Personalized Pressure feature which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it is calculate arterial occlusion pressure and set the optimal pressure for patient's body. There is no need for an external doppler probe or hand pump. This unit will do everything for patient. Smart Cuffs 3rd generation is FDA Approved Listed Class 1 device.
The automatized tourniquet (Smart Tools) contains a ring-shaped single- chamber
strengthening exercise
Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).
Interventions
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BFR
Blood flow restriction training is an accessory to a variety of different exercise modes (e.g., resistance exercise, walking, cycling) has recently become a popular research topic. It involves the application of pressurized cuffs to the proximal portion of each lower extremity or upper extremity. It enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet or cuff.
The 3rd Generation SmartCuffs® pump (SmartCuffs® 3.0 PRO) is Personalized Pressure feature which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it is calculate arterial occlusion pressure and set the optimal pressure for patient's body. There is no need for an external doppler probe or hand pump. This unit will do everything for patient. Smart Cuffs 3rd generation is FDA Approved Listed Class 1 device.
The automatized tourniquet (Smart Tools) contains a ring-shaped single- chamber
strengthening exercise
Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).
Eligibility Criteria
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Inclusion Criteria
* Both genders.
* BMI ranges from 18.5 to 29.9.
* Age ranges between 18 and 40 years experienced non-traumatic PFPS onset of anterior knee pain for greater than 2 weeks.
* Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.
Exclusion Criteria
* Other sources of anterior knee pain (bursa, fat pad).
* Previous knee surgery.
* Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
* Any cardiovascular disease.
* Uncontrolled hypertension.
* Any lower limb trauma.
* Hip and ankle pathology.
* BMI more than 30%.
* Pregnancy.
18 Years
35 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Mohamed Mahmoud Abdelaziz Khalil
doctor
Principal Investigators
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enas F youssef, Professor
Role: STUDY_CHAIR
Cairo University
abdelgalil A shaaban, PhD
Role: STUDY_DIRECTOR
Cairo University
ahmed S helal, PhD
Role: STUDY_DIRECTOR
Tanta University
ahmed M khalil, PhD
Role: STUDY_DIRECTOR
Pharos University in Alexandria
Locations
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Cairo University
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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This review found that BFR significantly improves muscle strength but is less effective than heavy-load training . BFR is a viable and tolerable rehab tool, needing personalized
The study examines how low-intensity cycling with and without blood flow restriction (BFR) impacts muscle strength, hypertrophy, and aerobic capacity, addressing whether BFR can simultaneously enhance both muscular and cardiovascular fitness.
Other Identifiers
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P.T.REC/012/005148
Identifier Type: OTHER
Identifier Source: secondary_id
P.T.REC/012/005148
Identifier Type: -
Identifier Source: org_study_id
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