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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Ghent University

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

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.

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 groups in NCT04996680
Study groupRoleWhat they receive
Blood flow restriction groupExperimentalpatients 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 groupSham comparatorpatients 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 groupActive comparatorpatients 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  1. First posted9 Aug 2021
  2. Study start14 Jul 2021
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

Resources

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)
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 40846463
  • Jacobs 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 39919906
  • Jacobs 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

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.

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