Severe Knee OsteoarthritisNCT07300384
Acute Effects of Blood Flow Restriction Training to Failure on Hypoalgesia in Patients With Severe Knee Osteoarthritis Using Dynamic or Fixed Occlusion Pressure
A study testing Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure. and Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure. in people with Severe Knee Osteoarthritis, run by University of Valencia at 2 sites in Spain.
Trial summary
This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Severe Knee Osteoarthritis
- What is being tested?
- Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure. and Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- 25 Feb 2026to Dec 2027
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 85 years
- Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.
- On the waiting list for unilateral total knee replacement (TKR) surgery
Who cannot join
- Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.
- Previous hip or knee replacement surgery and osteotomy within the last year.
- Autoimmune arthritis
- Medical conditions that contraindicate exercise.
- Participation in exercise programs (>2 days/week with training at intensities of 10-15 1RM) in the previous six months.
- History of stroke, brain surgery, major depression, or self-reported cognitive impairment that could affect performance in the study.
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- Cardiovascular, thrombotic, or vascular risk factors (uncontrolled hypertension, peripheral arterial disease, history of deep vein thrombosis or pulmonary embolism, heart failure, severe varicose veins, or uncontrolled anticoagulant therapy).
- Skin or local alterations at the cuff application site (ulcers, open wounds, infections, lymphedema, or severe edema).
- Inability to communicate normally or with impaired communication skills.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, 46010
Adrian Escriche-Escuder, PhD, +34 963 98 38 55, adrian.escriche@uv.es
Ignacio Coscollà-Agramunt, MSc
- Recruiting
University of Valencia
Valencia, Valencia
About this study
This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.
- Conditions
- Severe Knee Osteoarthritis
- Being tested
- Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure., Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.
- Keywords
- bood flow restriction, exercise, gonarthrosis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.Device
A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.
Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.Device
A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Exercise to failure under low load resistance with moderate blood occlusion and dynamic pressure. | Experimental | A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and dynamic pressure. Receives: Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure. |
| Exercise to failure under low load resistance with moderate blood occlusion and fixed pressure. | Experimental | A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and fixed pressure. Receives: Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest (Visual Analogue Scale, 0-10)
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Measured: Periprocedural
Secondary outcomes (7)
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer
Measured: Periprocedural
Perceived exertion scale (The BORG CR10 Scale)
The BORG CR10 Scale is a subjective tool used to measure the intensity of the perceived exertion of a person during an activity through a rate of perceived exertion (RPE). It is scored on a scale of 0 to 10, where 0 is no exertion and 10 is maximum exertion.
Measured: Periprocedural
Occurrence of adverse effects
Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.
Measured: Immediately after the intervention, 72 hours later, and two weeks after the study ended
Kinesiophobia (The Tampa Scale for Kinesiophobia)
The Tampa Scale for Kinesiophobia is a questionnaire designed to assess fear of movement and avoidance of physical activity due to pain. It consists of 17 items answered on a scale of 1 (strongly disagree) to 4 (strongly agree), measuring two main factors: fear of movement and activity avoidance. The total score ranges from 17 to 68 points, with higher scores indicating greater kinesophobia.
Measured: Before the intervention and at the end of the study
Pain catastrophizing
The Pain Catastrophizing Scale includes 13 items in total (0-52 points) that describe different thoughts and feelings associated with pain. The PCS consists of 5 grades: 0 not at all, 1 a little, 2 moderately, 3 a lot, and 4 always. The participant must mark their situation for each case. Higher scores correspond to higher levels of pain catastrophizing
Measured: Before the intervention and at the end of the study
Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a questionnaire designed to assess pain, stiffness, and function in patients with knee and hip osteoarthritis. It consists of 24 items, divided into three subscales that assess pain (5 items), stiffness (2 items), and physical function (17 items). Responses are given on a 0-to-4 Likert-type scale, where higher scores indicate greater impairment.
Measured: Before the intervention and at the end of the study
Number of Repetitions Performed
The number of maximum repetitions performed in each set will be assessed for each patient
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start25 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Escriche Escuder, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300384
- Sponsor's protocol ID
- 2025-FIS-3957418
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Blood Flow Restriction Training to Failure on Hypoalgesia in Patients With Severe Knee Osteoarthritis Using Dynamic or Fixed Occlusion Pressure
- ClinicalTrials.gov ID
- NCT07300384
- Acronym / sponsor ID
- 2025-FIS-3957418
- Conditions
- Severe Knee Osteoarthritis
- Keywords
- bood flow restriction, exercise, gonarthrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2025 (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 study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise to failure under low load resistance with moderate blood occlusion and dynamic pressure. | Experimental | Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and dynamic pressure. |
| Exercise to failure under low load resistance with moderate blood occlusion and fixed pressure. | Experimental | Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and fixed pressure. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 50 and 85 years
- Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.
- On the waiting list for unilateral total knee replacement (TKR) surgery
Key exclusion criteria (9 listed)
- Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.
- Previous hip or knee replacement surgery and osteotomy within the last year.
- Autoimmune arthritis
- Medical conditions that contraindicate exercise.
- Participation in exercise programs (>2 days/week with training at intensities of 10-15 1RM) in the previous six months.
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 |
|---|---|---|
| Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion. | Device | Exercise to failure under low load resistance with moderate blood occlusion and dynamic pressure. |
| Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion. | Device | Exercise to failure under low load resistance with moderate blood occlusion and fixed pressure. |
Primary outcome
Pain intensity at rest (Visual Analogue Scale, 0-10)
Time frame: Periprocedural
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
7 secondary outcomes
Pressure pain threshold
Time frame: Periprocedural
Perceived exertion scale (The BORG CR10 Scale)
Time frame: Periprocedural
Occurrence of adverse effects
Time frame: Immediately after the intervention, 72 hours later, and two weeks after the study ended
Kinesiophobia (The Tampa Scale for Kinesiophobia)
Time frame: Before the intervention and at the end of the study
Pain catastrophizing
Time frame: Before the intervention and at the end of the study
Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: Before the intervention and at the end of the study
Number of Repetitions Performed
Time frame: Periprocedural
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 10 Jun 2026.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available from the corresponding author upon reasonable request.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure. and Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure. in people with Severe Knee Osteoarthritis, run by University of Valencia at 2 sites in Spain.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Adrián Escriche-Escuder, PhD (+34 963 98 38 55, adrian.escriche@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest (Visual Analogue Scale, 0-10) (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.