Blood Flow RestrictionVOFIKONCT04996680
Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis
A study testing Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training and Standardised low load strength training in people with Blood Flow Restriction, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Recent research in strength training physiology revealed that implementation of occlusion garments around the proximal aspect of the lower limbs in combination with low load strength training causes a reduced blood flow and thus providing a high metabolic stimulus, causing a training effect similar to high load… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Blood Flow Restriction
- What is being tested?
- Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training and Standardised low load strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2021to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee osteoarthritis
- Speak Dutch, French or English
- No other pathology restricting patients to participate safe
- Time and motivation to visit 2x/w for 12 weeks
Who cannot join
- Neurological disorders
- previous surgery or disorder with blood vessels.
- (Symptomatic) heart or vascular disease
- Increased risk for DVT
- Avoiding physical exercise due to medical conditions.
- Rheumatoid arthritis
- BMI >30
- Recent severe trauma or surgery in the lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Recent research in strength training physiology revealed that implementation of occlusion garments around the proximal aspect of the lower limbs in combination with low load strength training causes a reduced blood flow and thus providing a high metabolic stimulus, causing a training effect similar to high load training. This study will investigate the added effect of BFR focussing on functional outcome, pain-management and lower limb strength in patients with knee osteoarthritis. Therefore, 234 patiens will be divided into three equal groups (n=78), (control group, sham group and BFR-group) which will be subjected to a 12-week during standard strength training program, 2 times a week for 60 minutes. The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.
Read the detailed description
Recent research in strength training physiology, revealed that implementation of occlusion garments around the proximal aspect of the segment submitted to strength training (i.e. the upper thigh, in case of lower limb and knee joint training) results in significant increments in metabolic and mechanical muscle loading, facilitating neuromuscular responses in terms of muscle fiber recruitment and muscle fiber hypertrophy/gains in muscle mass, even at fairly low training dosages (<50% of 1RM). As a consequence, BFR guided resistance training at low training intensities renders a training response similar to what can be expected from high intensity strength training. Occlusion at the proximal site of the segment submitted to strength training, reduces both vascular in- and outflow. This reduced blood flow is thought to induce an ischemic/hypoxic environment that enhances the training effect in the exercising muscle, leading to increased muscle mass and strength. In accordance with this theoretic framework, results of a recent study which compared the training effects between High Intensity Resistance Training (HIRT), Low Intensity Resistance Training (LIRT) and Low Intensity Resistance Training with BFR (BFRT), demonstrated that both the HIRT and the BFRT resulted in similar significant improvements in 1RM knee extension strength, functional performance and Quadriceps Cross Sectional Area (CSA), whereas no differences were found after a 12 week period of LIRT. On the contrary, pain scores objectified by means of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) significantly reduced in the BFRT, whereas this was not the case for the HIRT group in which 4 patients were also excluded due to the onset of exercise-induced knee pain. Although previous scientific research has already provided a quite solid proof of concept by assessing the short term results of BFR training in small sample sizes of patients at risk of or suffering from knee OA, ready-to-use guidelines and specific implementation instructions of BFR-based physical therapy and strength training are non-existent at present. With this TBM project, it is our intention to reinforce the scientific evidence regarding the substantial benefits and significant added value of BFR-guided low intensity resistance training in both the stabilization and rehabilitation of knee osteoarthritis, as well as to provide the clinicians ((para)medics and trainers) in hospital, clinical practice and fitness/training settings with specific guidelines with regard to practical implementation of respective exercise protocols.
This will be done using a large scale Randomized Clinical Trial Design in which a standardized strength training protocol will be implemented for functional rehabilitation purposes in a population of 234 participants diagnosed with knee OA, using three different loading categories:
- (n=78) Low Load Resistance Training (Control)
- (n=78) Blood Flow Restricted Low Load Resistance Training (BFRT)
- (n=78) Low Load Resistance Training with sham BFR component (Sham). The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.
The intervention consists of a 12 week during standardised strength program, 2 times a week for 60 minutes. To evaluate and objectify any training effect, patient overall Quality of Life (QoL) and knee function, 4 screening moments are planned; at baseline (week 0), after 6 weeks, post intervention (13 weeks) and a follow-up screening after 6 months to assess the retention effect and thus, the sustainability of this training modality.
- Conditions
- Blood Flow Restriction
- Being tested
- Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training, Standardised low load strength training, Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training
- Keywords
- Blood Flow Restriction, Strength training, Knee Osteoarthritis
- 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 (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh trainingDevice
Also called Kaatsu, partial vascular occlusion
This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with optimal pressurized blood flow restriction
Standardised low load strength trainingOther
This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises
Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingDevice
This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with blood flow restriction, but pressurized so the occlusion cuff has no significant effect on the lower limb blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction group | Experimental | patients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will reduce the amount of blood flow and therefore increase the metabolic stimulus. The cuff will be used only during one quadriceps exercise, 2 times a week for 12 weeks. Receives: Device: Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training |
| Sham group | Sham comparator | patients in this group will undergo the same standard strength training program as the BFR-group, combined with an occlusion cuff but pressurized so there is no significant effect on the lower limb blood flow. The cuff will be used only during one quadriceps exercise, 2 times a week for 12 weeks. Receives: Device: Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training |
| Control group | Active comparator | patients in this group will undergo the same standard strength training program as the BFR-group and placebo-group, but without a tourniquet. Receives: Other: Standardised low load strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change within Knee Injury and Osteoarthritis Outcome Score (KOOS)
A comprehensive analysis of patient function at level of activities of daily living as well as in sports participation. KOOS consists of 5 subscales: (1) Pain, (2) other Symptoms, (3) Function in daily living (ADL), (4) Function in sport and recreation (Sport/Rec) and (5) knee related Quality of life (QOL).
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Secondary outcomes (9)
Assessing change within Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) will evaluate the patient's tendency towards pain catastrophizing and risk of developing chronic pain, and as such the quality of the patients psychosocial health status.
Measured: 4 times; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within thigh muscle strength
objectified by means of Hand Held Dynamometry (HHD) assessment (maximal isometric muscle strength) of the quadriceps and hamstring muscle. Each muscle will be tested in a standardized fashion and sequence. The patient will be informed about the purpose and the content of each strength test, after which the investigator will demonstrate which muscle will be tested, the starting position that should be adopted as well as the specific location and direction at/in which the static resistance will be applied. Afterwards, the participants will be tested once at submaximal and twice at maximal level of isometric strength output, after which the best trial will be taken into account for data registration and processing.
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within Single leg Hop for Distance (SHD)
unilateral jump and landing. Patient get 3 attempts on both sides
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within Knee Bent Test (KBT)
unilateral knee flexion and extension (~unilateral squat)
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within 6 minute walk test (6MWT)
walk as far as possible within 6 minutes. Patient is allowed to take a break during the test, although time keeps counting down.
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within 40m FPWT
40m walking as fast as possible
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within chair stand test
go from sit (on a chair) to stand as much as possible within 30 seconds
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
assessing change within stair climb test
go 11 steps upwards and downwards on a stair as fast as possible (although safe)
Measured: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within International physical activity questionnaire (IPAQ)
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity from the last 7 days
Measured: assessing change every week, starting from baseline (Week 0) until the follow-up after 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start14 Jul 2021
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood Flow RestrictionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, Prof. dr., Study chair, Rehabilitation science & Physiotherapy Ghent UniversityJan Victor, Prof. Dr., Principal investigator, Orthopedics & Traumatology Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996680
- Sponsor's protocol ID
- BC-09925
- Acronym
- VOFIKO
- Status last verified
- May 2024
- First submitted
- 12 Jul 2021
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jacobs E, Stroobant L, Witvrouw E, Victor J, Acx F, van der Jeugt J, Schuermans J, Wezenbeek E. Sustained benefits of blood flow restriction therapy in knee osteoarthritis rehabilitation: 1-year follow-up of a randomised controlled trial. Br J Sports Med. 2025 Nov 26;59(21):1481-1489. doi: 10.1136/bjsports-2024-109524.
PubMed 40846463Jacobs E, Stroobant L, Victor J, Elewaut D, Tampere T, Wallaert S, Witvrouw E, Schuermans J, Wezenbeek E. Vascular occlusion for optimising the functional improvement in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2025 Feb;84(2):341-350. doi: 10.1136/ard-2024-226579. Epub 2025 Jan 2.
PubMed 39919906Jacobs E, Rolnick N, Wezenbeek E, Stroobant L, Capelleman R, Arnout N, Witvrouw E, Schuermans J. Investigating the autoregulation of applied blood flow restriction training pressures in healthy, physically active adults: an intervention study evaluating acute training responses and safety. Br J Sports Med. 2023 Jul;57(14):914-920. doi: 10.1136/bjsports-2022-106069. Epub 2023 Jan 5.
PubMed 36604156
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04996680
- Acronym / sponsor ID
- VOFIKO / BC-09925
- Conditions
- Blood Flow Restriction
- Keywords
- Blood Flow Restriction, Strength training, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 9 Aug 2021 (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.
Recent research in strength training physiology revealed that implementation of occlusion garments around the proximal aspect of the lower limbs in combination with low load strength training causes a reduced blood flow and thus providing a high metabolic stimulus, causing a training effect similar to high load training. This study will investigate the added effect of BFR focussing on functional outcome, pain-management and lower limb strength in patients with knee osteoarthritis. Therefore, 234 patiens will be divided into three equal groups (n=78), (control group, sham group and BFR-group) which will be subjected to a 12-week during standard strength training program, 2 times a week for 60 minutes. The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.
Detailed description
Recent research in strength training physiology, revealed that implementation of occlusion garments around the proximal aspect of the segment submitted to strength training (i.e. the upper thigh, in case of lower limb and knee joint training) results in significant increments in metabolic and mechanical muscle loading, facilitating neuromuscular responses in terms of muscle fiber recruitment and muscle fiber hypertrophy/gains in muscle mass, even at fairly low training dosages (<50% of 1RM). As a consequence, BFR guided resistance training at low training intensities renders a training response similar to what can be expected from high intensity strength training. Occlusion at the proximal site of the segment submitted to strength training, reduces both vascular in- and outflow. This reduced blood flow is thought to induce an ischemic/hypoxic environment that enhances the training effect in the exercising muscle, leading to increased muscle mass and strength. In accordance with this theoretic framework, results of a recent study which compared the training effects between High Intensity Resistance Training (HIRT), Low Intensity Resistance Training (LIRT) and Low Intensity Resistance Training with BFR (BFRT), demonstrated that both the HIRT and the BFRT resulted in similar significant improvements in 1RM knee extension strength, functional performance and Quadriceps Cross Sectional Area (CSA), whereas no differences were found after a 12 week period of LIRT. On the contrary, pain scores objectified by means of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) significantly reduced in the BFRT, whereas this was not the case for the HIRT group in which 4 patients were also excluded due to the onset of exercise-induced knee pain. Although previous scientific research has already provided a quite solid proof of concept by assessing the short term results of BFR training in small sample sizes of patients at risk of or suffering from knee OA, ready-to-use guidelines and specific implementation instructions of BFR-based physical therapy and strength training are non-existent at present. With this TBM project, it is our intention to reinforce the scientific evidence regarding the substantial benefits and significant added value of BFR-guided low intensity resistance training in both the stabilization and rehabilitation of knee osteoarthritis, as well as to provide the clinicians ((para)medics and trainers) in hospital, clinical practice and fitness/training settings with specific guidelines with regard to practical implementation of respective exercise protocols.
This will be done using a large scale Randomized Clinical Trial Design in which a standardized strength training protocol will be implemented for functional rehabilitation purposes in a population of 234 participants diagnosed with knee OA, using three different loading categories:
- (n=78) Low Load Resistance Training (Control)
- (n=78) Blood Flow Restricted Low Load Resistance Training (BFRT)
- (n=78) Low Load Resistance Training with sham BFR component (Sham). The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.
The intervention consists of a 12 week during standardised strength program, 2 times a week for 60 minutes. To evaluate and objectify any training effect, patient overall Quality of Life (QoL) and knee function, 4 screening moments are planned; at baseline (week 0), after 6 weeks, post intervention (13 weeks) and a follow-up screening after 6 months to assess the retention effect and thus, the sustainability of this training modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction group | Experimental | Device: Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh trainingpatients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will reduce the amount of blood flow and therefore increase the metabolic stimulus. The cuff will be used only during one quadriceps exercise, 2 times a week for 12 weeks. |
| Sham group | Sham comparator | Device: Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingpatients in this group will undergo the same standard strength training program as the BFR-group, combined with an occlusion cuff but pressurized so there is no significant effect on the lower limb blood flow. The cuff will be used only during one quadriceps exercise, 2 times a week for 12 weeks. |
| Control group | Active comparator | Other: Standardised low load strength trainingpatients in this group will undergo the same standard strength training program as the BFR-group and placebo-group, but without a tourniquet. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with knee osteoarthritis
- Speak Dutch, French or English
- No other pathology restricting patients to participate safe
- Time and motivation to visit 2x/w for 12 weeks
Key exclusion criteria (8 listed)
- Neurological disorders
- previous surgery or disorder with blood vessels.
- (Symptomatic) heart or vascular disease
- Increased risk for DVT
- Avoiding physical exercise due to medical conditions.
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 (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh trainingAlso: Kaatsu, partial vascular occlusionThis group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with optimal pressurized blood flow restriction | Device | Blood flow restriction group |
| Standardised low load strength trainingThis group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises | Other | Control group |
| Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingThis group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with blood flow restriction, but pressurized so the occlusion cuff has no significant effect on the lower limb blood flow. | Device | Sham group |
Primary outcome
Assessing change within Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
A comprehensive analysis of patient function at level of activities of daily living as well as in sports participation. KOOS consists of 5 subscales: (1) Pain, (2) other Symptoms, (3) Function in daily living (ADL), (4) Function in sport and recreation (Sport/Rec) and (5) knee related Quality of life (QOL).
9 secondary outcomes
Assessing change within Pain Catastrophizing Scale (PCS)
Time frame: 4 times; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within thigh muscle strength
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within Single leg Hop for Distance (SHD)
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within Knee Bent Test (KBT)
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within 6 minute walk test (6MWT)
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within 40m FPWT
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within chair stand test
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
assessing change within stair climb test
Time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.
Assessing change within International physical activity questionnaire (IPAQ)
Time frame: assessing change every week, starting from baseline (Week 0) until the follow-up after 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 40846463Jacobs E, Stroobant L, Witvrouw E, Victor J, Acx F, van der Jeugt J, Schuermans J, Wezenbeek E. Sustained benefits of blood flow restriction therapy in knee osteoarthritis rehabilitation: 1-year follow-up of a randomised controlled trial. Br J Sports Med. 2025 Nov 26;59(21):1481-1489. doi: 10.1136/bjsports-2024-109524.
- Derived from this study: PubMed 39919906Jacobs E, Stroobant L, Victor J, Elewaut D, Tampere T, Wallaert S, Witvrouw E, Schuermans J, Wezenbeek E. Vascular occlusion for optimising the functional improvement in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2025 Feb;84(2):341-350. doi: 10.1136/ard-2024-226579. Epub 2025 Jan 2.
- Derived from this study: PubMed 36604156Jacobs E, Rolnick N, Wezenbeek E, Stroobant L, Capelleman R, Arnout N, Witvrouw E, Schuermans J. Investigating the autoregulation of applied blood flow restriction training pressures in healthy, physically active adults: an intervention study evaluating acute training responses and safety. Br J Sports Med. 2023 Jul;57(14):914-920. doi: 10.1136/bjsports-2022-106069. Epub 2023 Jan 5.
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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.
Erik Witvrouw, Prof. dr. study chair
Rehabilitation science & Physiotherapy Ghent University
Jan Victor, Prof. Dr. principal investigator
Orthopedics & Traumatology Ghent University Hospital
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 (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training and Standardised low load strength training in people with Blood Flow Restriction, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 May 2024. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing change within Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: assessing change at 4 time points; 1) baseline screening (week 0), 2) after 6 weeks, 3) post intervention after 13 weeks and 4) follow-up screening after 24 weeks.). 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 NCT04996680, which also lists 3 linked publications.
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 20 May 2024.