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

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.

Conditions

• Knee Osteoarthritis
• Blood Flow Restriction Therapy

Interventions

DEVICE

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.

DEVICE

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).

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Lecturer · Cairo University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-15

Primary Completion

2025-02-26

Completion

2026-05-06

FDA Device

Yes

Countries

• Egypt