Knee OsteoarthritisNCT06637124
Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients With Knee Osteoarthritis
A study testing Blood Flow Restriction Therapy Device and 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. in people with Knee Osteoarthritis and Blood Flow Restriction Therapy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Blood Flow Restriction Therapy
- What is being tested?
- Blood Flow Restriction Therapy Device and 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 6 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restriction With Different Loads Versus Moderate Resistive Exercises in Patients With Knee Osteoarthritis: A Double Blinded Randomized Controlled Trial
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:
Read more
- 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 ?
- 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 ?
- 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 ?
- 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 ?
- 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:
- 16 sessions of supervised intervention 2 times per week for 8 weeks.
- The assessment will be at 3 time points, baseline and at 4 weeks and at 8 weeks.
Read the detailed description
Knee osteoarthritis (KOA) is a prevalent degenerative musculoskeletal condition that primarily causing pain, stiffness, and disability. It is a multifactorial disease influenced by a combination of genetic, biomechanical, and environmental factors Osteoarthritis Research Society International (ORSI) recommended strength training as a possible treatment method to slow progression of knee OA. Strength training, as recommended by the American College of Sports Medicine (ACSM), must be performed at a minimum resistance training load of 60% to 70% 1-repetition maximum (1RM) for strength improvement.
Only 13% of older patients with knee OA satisfactorily can perform moderate to vigorous physical activity.
Unfortunately, risk factors of knee OA (as obesity, knee pain, knee injury/surgery) also contribute to a perceived reduced tolerance to the resistive training programs recommended for eliciting strength gains.
An alternative to traditional strength training that may be well tolerated by patients with Knee OA is Blood flow restriction (BFR) training.
This reduced blood flow creates a unique physiological environment, inducing a state of metabolic stress and cellular hypoxia in the muscles.
Although the advantages of BFRT in musculoskeletal rehabilitation that reported in the literature, there are conflicting results compared to traditional exercises, as the different protocols parameters, exercises, high risk of bias across previous studies contribute to different conclusions.
Consequently, it raises the question if BFR without exercises can be effective in comparison with traditional exercises that focus on having an efficient intensity to produce muscle strength gain.
Yet, up to authors knowledge, no study has assessed whether BFR at rest could also promote similar gains in muscle strength for the knee OA treatment, which theoretically would increase patient's adherence to KOA treatment based on conclusions of systemic review of BFR without exercises for immobilized patients after orthopedic surgery (Cerqueira et al., 2019).
Another relevant issue is the proper blood flow restriction level for optimal results. Thus, pushes the need for determining a pressure load with the least adverse effects.
Therefore, the main purpose of this study is to assess different protocols of BFR without additional exercises compared to MI-RT for pain reduction in patients with KOA. The secondary purpose is to compare two load levels (70% vs 50%) of BFRT regarding pain, quadriceps muscle strength, rate of perceived exertion, self reported physical function, and functional ability.
- Being tested
- Blood Flow Restriction Therapy Device, 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.
- Keywords
- Blood Flow Restriction, Knee osteoarthritis, Moderate Intenstity Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Therapy DeviceDevice
Also called Smart cuffs 4.0
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.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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured 3 times at baseline, 4 weeks and 8 weeks
Secondary outcomes (3)
Change in functional ability
Measured by Timed Up and Go Test (TUG) to assess participants' mobility, balance, and functional performance.
- The time taken by the patient to complete the entire sequence from rising from the chair to returning to a seated position will be measured.
- This time will be recorded in seconds, representing the TUG test score.
- 3 times will be conducted to ensure the accuracy of the TUG test score.
- The average time from these trials will be calculated for a more reliable result.
- High Risk of fall (\>13.5 seconds)
- None/low/moderate (\<13.5 seconds) The lower the number the better as it represents better mobility, balance and functional performance.
Measured: Measured 3 times at baseline, 4 weeks and 8 weeks
Change in physical function levels
Measured by Arabic version of Western Ontario McMaster Universities Osteoarthritis Index for Knee Function (ArWOMAC).
The WOMAC questionnaire will be handed out to the participants. They will be informed that it consists of a series of questions related to their knee symptoms and how these symptoms affect their daily activities.
WOMAC is assigned a numerical score of 0-4 corresponding to severity (none, mild, moderate, severe, and extreme). The minimum score is 0, and the maximum score is 96 (20 points for pain, 8 points for joint stiffness, and 68 points for physical function).
The lower the score the better.
Measured: Measured 3 times at baseline, 4 weeks and 8 weeks
Change in Rate of perceived exertion scale (RPE)
Measured by Arabic version of Omnibus Resistance Exercise 0-10 (OMNI-RES) as a scale for measuring an individual's effort and exertion, breathlessness and fatigue during physical work.
- The OMNI Picture System is a collection of category scales used for rating of perceived exertion (RPE) as the subjective intensity of a person's feelings of effort, strain, discomfort, and/or fatigue when engaged in exercise or other physical activities.
- With OMNI exertion scales, users select a number from 0 to 10 that best corresponds to their perceived intensity of physical exertion.
- 0 represents extremely easy and 10 represents extremely hard.
- The lower the number the better.
Measured: Measured 3 times at basline , 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion26 Feb 2025
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Fouad Gomaa El Gamal, Cairo University
- Investigators
- Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637124
- Sponsor's protocol ID
- P.T.REC/012/005029
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: * The risk that sharing prevents the exploitation of the entire potential of the data obtained. * Possible failures in patients' privacy protection. * Technical barriers such as the lack of standard formats and possible data misinterpretation. * Issues regarding data ownership. * Reuse of data for unfair commercial purposes.
Publications
Tahoon AM, El Gamal FFG, Metawee SM, Khaled N, Abdelkader NA. Blood flow restriction with different loads versus moderate intensity resistive exercises in patients with knee osteoarthritis: a single-blind randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Oct 7;18(1):473. doi: 10.1186/s13102-026-02068-y.
PubMed 42859165
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction With Different Loads Versus Moderate Resistive Exercises in Patients With Knee Osteoarthritis: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06637124
- Acronym / sponsor ID
- P.T.REC/012/005029
- Keywords
- Blood Flow Restriction, Knee osteoarthritis, Moderate Intenstity Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 15 Oct 2024 (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 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:
- 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 ?
- 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 ?
- 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 ?
- 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 ?
- 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:
- 16 sessions of supervised intervention 2 times per week for 8 weeks.
- The assessment will be at 3 time points, baseline and at 4 weeks and at 8 weeks.
Detailed description
Knee osteoarthritis (KOA) is a prevalent degenerative musculoskeletal condition that primarily causing pain, stiffness, and disability. It is a multifactorial disease influenced by a combination of genetic, biomechanical, and environmental factors Osteoarthritis Research Society International (ORSI) recommended strength training as a possible treatment method to slow progression of knee OA. Strength training, as recommended by the American College of Sports Medicine (ACSM), must be performed at a minimum resistance training load of 60% to 70% 1-repetition maximum (1RM) for strength improvement.
Only 13% of older patients with knee OA satisfactorily can perform moderate to vigorous physical activity.
Unfortunately, risk factors of knee OA (as obesity, knee pain, knee injury/surgery) also contribute to a perceived reduced tolerance to the resistive training programs recommended for eliciting strength gains.
An alternative to traditional strength training that may be well tolerated by patients with Knee OA is Blood flow restriction (BFR) training.
This reduced blood flow creates a unique physiological environment, inducing a state of metabolic stress and cellular hypoxia in the muscles.
Although the advantages of BFRT in musculoskeletal rehabilitation that reported in the literature, there are conflicting results compared to traditional exercises, as the different protocols parameters, exercises, high risk of bias across previous studies contribute to different conclusions.
Consequently, it raises the question if BFR without exercises can be effective in comparison with traditional exercises that focus on having an efficient intensity to produce muscle strength gain.
Yet, up to authors knowledge, no study has assessed whether BFR at rest could also promote similar gains in muscle strength for the knee OA treatment, which theoretically would increase patient's adherence to KOA treatment based on conclusions of systemic review of BFR without exercises for immobilized patients after orthopedic surgery (Cerqueira et al., 2019).
Another relevant issue is the proper blood flow restriction level for optimal results. Thus, pushes the need for determining a pressure load with the least adverse effects.
Therefore, the main purpose of this study is to assess different protocols of BFR without additional exercises compared to MI-RT for pain reduction in patients with KOA. The secondary purpose is to compare two load levels (70% vs 50%) of BFRT regarding pain, quadriceps muscle strength, rate of perceived exertion, self reported physical function, and functional ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50% Blood Flow Restriction Group | Experimental | Device: Blood Flow Restriction Therapy DeviceThe 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. |
| 70% Blood Flow Restriction Group | Experimental | Device: Blood Flow Restriction Therapy DeviceThe 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. |
| Moderate Intensity Exercise training Group | Active comparator | Device: 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Blood Flow Restriction Therapy DeviceAlso: Smart cuffs 4.0Blood 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). | Device | 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.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 | Moderate Intensity Exercise training Group |
Primary outcome
Change in pain intensity
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in functional ability
Time frame: Measured 3 times at baseline, 4 weeks and 8 weeks
Change in physical function levels
Time frame: Measured 3 times at baseline, 4 weeks and 8 weeks
Change in Rate of perceived exertion scale (RPE)
Time frame: Measured 3 times at basline , 4 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 42859165Tahoon AM, El Gamal FFG, Metawee SM, Khaled N, Abdelkader NA. Blood flow restriction with different loads versus moderate intensity resistive exercises in patients with knee osteoarthritis: a single-blind randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Oct 7;18(1):473. doi: 10.1186/s13102-026-02068-y.
- Individual participant dataSharing planned: No. * The risk that sharing prevents the exploitation of the entire potential of the data obtained. * Possible failures in patients' privacy protection. * Technical barriers such as the lack of standard formats and possible data misinterpretation. * Issues regarding data ownership. * Reuse of data for unfair commercial purposes.
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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.
Lecturer study director
Cairo 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 Blood Flow Restriction Therapy Device and 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. in people with Knee Osteoarthritis and Blood Flow Restriction Therapy, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in pain intensity (time frame: Measured 3 times at basline, 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06637124, which also lists 1 linked publication.
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 6 May 2026.