Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients With K… (NCT06637124) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients With Knee Osteoarthritis
Egypt75 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain intensity
Timeframe: Measured 3 times at basline, 4 weeks and 8 weeks
2
Measure change in quadriceps muscle strength
Timeframe: Measured 3 times at baseline, 4 weeks and 8 weeks