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

NCT06637124 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P.T.REC/012/005029
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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. 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 ?
6. 6.16 sessions of supervised intervention 2 times per week for 8 weeks.
7. 7.The assessment will be at 3 time points, baseline and at 4 weeks and at 8 weeks.

Conditions

Knee Osteoarthritis; Blood Flow Restriction Therapy

Keywords

Blood Flow Restriction; Knee osteoarthritis; Moderate Intenstity Exercise

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity

  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.

  Measured 3 times at basline, 4 weeks and 8 weeks

• Measure change in quadriceps muscle strength

  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.

  Measured 3 times at baseline, 4 weeks and 8 weeks

Secondary Outcomes (3)

• Change in functional ability

  Measured 3 times at baseline, 4 weeks and 8 weeks

• Change in physical function levels

  Measured 3 times at baseline, 4 weeks and 8 weeks

• Change in Rate of perceived exertion scale (RPE)

  Measured 3 times at basline , 4 weeks and 8 weeks

Study Arms (3)

50% Blood Flow Restriction Group

EXPERIMENTAL

The Blood Flow Restriction device will be set to restrict blood flow at level of 50% of arterial occlusion pressure at rest. Blood Flow Restriction sessions will be 5 sets of 5 mins of occlusion and 3 mins of free flow , 2 sessions per week for eight weeks exercises to assess its effects on knee osteoarthritis-related outcomes.

Device: Blood Flow Restriction Therapy Device

70% Blood Flow Restriction Group

EXPERIMENTAL

The Blood Flow Restriction device will be set to restrict blood flow at level of 70% of arterial occlusion pressure at rest. Blood Flow Restriction sessions will be 5 sets of 5 mins of occlusion and 3 mins of free flow , 2 sessions per week for eight weeks exercises to assess its effects on knee osteoarthritis-related outcomes.

Device: Blood Flow Restriction Therapy Device

Moderate Intensity Exercise training Group

ACTIVE COMPARATOR

Patients assigned to this group will receive strengthening of the lower limb musculature through moderate intensity resistance training (60% of 1RM) for a total of 16 treatment sessions according to exercise guidelines for seniors with OA. MIRT protocols consists of 3 sets for every exercise, 12 repetitions per set, rest period between sets 2 mins, 2 session per week for 8 weeks. Resistance exercises will be performed using a 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.

Device: 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.

Interventions

Blood Flow Restriction Therapy Device 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).

Also known as: Smart cuffs 4.0

50% Blood Flow Restriction Group; 70% Blood Flow Restriction Group

45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. DEVICE

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.

Moderate Intensity Exercise training Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

CairoU

Cairo, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Degree Student in Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: February 26, 2025
• Study Completion: May 6, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)