Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis

NCT ID: NCT04996680

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2024-02-27

Brief 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 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.

Conditions

Blood Flow Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Blood flow restriction group

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training

Intervention Type: DEVICE

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

Sham group

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.

Group Type: SHAM_COMPARATOR

Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training

Intervention Type: DEVICE

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.

Control group

patients in this group will undergo the same standard strength training program as the BFR-group and placebo-group, but without a tourniquet.

Group Type: ACTIVE_COMPARATOR

Standardised low load strength training

Intervention Type: OTHER

This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises

Interventions

Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training

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

Intervention Type: DEVICE

Standardised low load strength training

This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises

Intervention Type: OTHER

Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training

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.

Intervention Type: DEVICE

Other Intervention Names

Kaatsu; partial vascular occlusion

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Witvrouw, Prof. dr.

Role: STUDY_CHAIR

Rehabilitation science & Physiotherapy Ghent University

Jan Victor, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Orthopedics & Traumatology Ghent University Hospital

Locations

Ghent University

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

References

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 Aug 22:bjsports-2024-109524. doi: 10.1136/bjsports-2024-109524. Online ahead of print.

Reference Type: DERIVED

PMID: 40846463 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39919906 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36604156 (View on PubMed)

Other Identifiers

BC-09925

Identifier Type: -

Identifier Source: org_study_id