Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients With Knee Osteoarthritis

NCT06637124 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2024-10-15

Last updated

2026-05-06

Condition(s) studied

Knee OsteoarthritisBlood Flow Restriction Therapy

Investigational drug(s) / intervention(s)

Blood Flow Restriction Therapy Device45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.

Blood Flow Restriction Therapy Device: Blood Flow Restriction (BFR) therapy involves units use standardized cuffs of varying widths and lengths which are physically attached to the devices and provide the capability of precisely controlling the amount of pressure applied to each limb during exercise or at rest. We will be using Smart Cuffs® 4.0 which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it will calculate and set the optimal pressure for each participant's limb. There is no need for an external doppler probe or hand pump. Made in the USA, SmartCuffs® are registered with the FDA as a Class 1 Medical Device. Blood flow restriction therapy is commonly paired with resistive training, so this study will explore the effect of blood flow restriction at rest for patients with osteoarthritis at different restriction levels (50% for first group and 70% for second group).

45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.: Patients assigned to group will receive strengthening of the lower limb musculature through moderate intensity resistance training (60% of 1RM) using a 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.

Study summary

This clinical trail will be conducted to investigate the effect of blood flow restriction (BFR) with different load levels between low blood occlusion percentage (50%) group and high blood occlusion percentage (70%) compared to moderate intensity training (60% of 1 RM) in patients with chronic knee osteoarthritis.

The main questions it aims to answer are:

1. Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on pain intensity in knee osteoarthritis ?
2. Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on quadriceps muscle strength in knee osteoarthritis ?
3. Will there be no difference difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on rate of perceived exertion in knee osteoarthritis ?
4. Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on functional ability in knee osteoarthritis ?
5. Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on physical function in knee osteoarthritis ?

All participants will receive:

1. 16 sessions of supervised intervention 2 times per week for 8 weeks.
2. The assessment will be at 3 time points, baseline and at 4 weeks and at 8 weeks.

Eligibility

Sex

ALL

Min age

40 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Patients diagnosed with chronic knee osteoarthritis referred by orthopedic surgeons participants of both genders age are 40-65. * Patients with grade 2 and 3 OA of the knee, according to radiologic evaluation * If both knees diagnosed as OA, the most affected one will be selected. * Diagnosis of Knee OA who had knee pain and functional disabilities for at least three months, according to American College of Rheumatology classification at screening visit. * Visual Analogue Scale (VAS) at rest score of ≥40 mm. * Arabic version of the western WOMAC (ArWOMAC) scores (average 37). * Moderate Physical activity score on the IPAQ (between 3.0 and 7.9 METS). Exclusion Criteria: * Moderate to significant knee synovitis * Hot or red knee * History and/or physical examination findings compatible with the internal derangement of knee. * Knee pain that is initiated or increased with knee activity/exercise and finished or decreased with knee resting. * Other muscular, articular, or neurological condition affecting lower limb function. * Patients with any previous knee surgeries or fractures of lower limb * Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during the previous 6 months. * Psychological or psychiatric disorders that may affect a subject's participation in the study. * Participants with congenital musculoskeletal lower limb deformity. * Participated in other intervention studies on the past 6 months to screening * Participants with contraindications to blood flow Restriction Training.

Primary outcome measure(s)

Change in pain intensity — Measured 3 times at basline, 4 weeks and 8 weeks
Measured by the Visual Analog Scale (VAS)which is a pain intensity assessment tool. * Represented with a 10 cm line with 0 indicating no pain and on the other end 10 indicating severe pain. * The patient is asked to move a marker on the line to the position which best describes their pain. * That it will serve as a subjective measure of their current level of knee pain intensity. The closer the mark to zero is better.
Measure change in quadriceps muscle strength — Measured 3 times at baseline, 4 weeks and 8 weeks
Hand-held dynamometer (HHD) will be used to measure the strength in quadriceps muscle. * The maximum force or pressure exerted by the quadriceps muscle during the contraction will be recorded. * Typically, this measurement is expressed in kilograms (kg) and then transferred to Newtons (N) * To enhance reliability, 3 trials may be conducted, and average will be taken to obtain a more representative measurement of muscle strength. * The higher the measurement the higher the muscle strength.

Trial sites (1)

Facility	City	Region	Status
CairoU	Cairo	Giza Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06637124 on ClinicalTrials.gov ↗ ← All trials in Egypt