Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis

NCT04996680 | Completed FDA Device

• 1 other identifier: BC-09925
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Flow Restriction

Keywords

Blood Flow Restriction; Strength training; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (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).

  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)

  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

  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)

  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)

  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)

  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.

Study Arms (3)

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.

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.

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.

Other: Standardised low load strength training

Interventions

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

Also known as: Kaatsu, partial vascular occlusion

Blood flow restriction group

Standardised low load strength training OTHER

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

Control group

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

Sham group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 40846463 DERIVED

• 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.

  PMID: 39919906 DERIVED

• 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.

  PMID: 36604156 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Erik Witvrouw, Prof. dr.

  Rehabilitation science & Physiotherapy Ghent University

  STUDY CHAIR

• Jan Victor, Prof. Dr.

  Orthopedics & Traumatology Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assignment to the BFR or control group was stratified by sex (male/female/X) and affected leg (right, left, both), and only visible for physiotherapists treating patients. The study was single-blinded, as the outcome assessors were blinded from randomization whereas masking of participants was not possible due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 9, 2021
• Study Start: July 14, 2021
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

BE (1)