Effects of Blood-flow Restricted Exercise Compared to Standard Rehabilitation in Patients With Knee Osteoarthritis

NCT05437770 | Completed DMC

• 1 other identifier: BRS-090288
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of low-intensity BFR exercise on joint pain, muscle mass, and mechanical muscle function compared to standard rehabilitering in adults with knee-OA.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Blood-flow restriction; Exercise

Outcome Measures

Primary Outcomes (4)

• Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale

  KOOS is a patient reported outcome instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Primary outcome will be an assessment of the Pain subscale as a total KOOS score has not been validated. A normalized score for the entire subscale will be calculated and reported, ranging from zero (extreme symptoms) to 100 (no symptoms).

  Baseline (0 weeks)

• Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale

  KOOS is a patient reported outcome instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Primary outcome will be an assessment of the Pain subscale as a total KOOS score has not been validated. A normalized score for the entire subscale will be calculated and reported, ranging from zero (extreme symptoms) to 100 (no symptoms).

  8 weeks of training.

• Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale

  KOOS is a patient reported outcome instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Primary outcome will be an assessment of the Pain subscale as a total KOOS score has not been validated. A normalized score for the entire subscale will be calculated and reported, ranging from zero (extreme symptoms) to 100 (no symptoms).

  12 weeks of training.

• Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale

  KOOS is a patient reported outcome instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Primary outcome will be an assessment of the Pain subscale as a total KOOS score has not been validated. A normalized score for the entire subscale will be calculated and reported, ranging from zero (extreme symptoms) to 100 (no symptoms).

  6 months after the training intervention period.

Secondary Outcomes (13)

• Myofiber Cross-Sectional Area (CSA)

  Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period)

• Pain Pressure Threshold (PPT)

  Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period)

• Maximal Voluntary Isometric Contraction (MVIC)

  Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period)

• Rate of Force Development (RFD)

  Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period)

• 4x10m Fast-Paced Walk Test (40m-FWT)

  At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period)

Study Arms (2)

BFR (Blood-Flow Restricted exercise)

EXPERIMENTAL

The BFR training intervention group will perform low load blood-flow restricted exercise. Training twice a week for 12 weeks. The group will also attend a two hours education lecture with osteoarthritis information.

Other: BFR (Blood-Flow Restricted exercise)

Standard rehabilitation

ACTIVE COMPARATOR

The standard rehabilitation group will be offered participation in the Good Life with osteoArthritis in Denmark programme (GLA:D). The programme includes supervised team group training twice a week for 8 weeks and an education lecture. The GLA:D programme will be followed by 4 weeks of team group training continuing the exercises from the GLA:D programme.

Other: Standard rehabilitation

Interventions

BFR (Blood-Flow Restricted exercise) OTHER

The BFR group performs unilateral training with the knee-OA diagnosed leg first. BFR exercise is performed with a pneumatic cuff placed at the top of the thigh on the leg being trained. The cuff will be inflated to 60-80 % of the total arterial occlusion pressure (AOP). The participant will afterwards perform training of the knee extensors in a leg press exercise machine and a leg extension exercise machine with a load corresponding to 30 % of the maximal load (1RM = Repetition Maximum).

BFR (Blood-Flow Restricted exercise)

Standard rehabilitation OTHER

The GLA:D programme involves a circuit training program with four stations. Each station involves two to six exercises where the participants perform 10-15 repetitions over 2-3 sets, which depends on the participants pain- and functional level. Following the 8 weeks GLA:D programme, participants will continue 4 weeks of team group training performing similar neuromuscular lower limb exercises as for the first 8 weeks.

Standard rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must meet the American College of Rheumatology (ACR) criteria for OA 35.
• Visible OA on X-ray pictures (Kellgren \& Lawrence grade 2-3).
• Unilateral pain and functional limitation for a minimum of 3 months.
• Be able to voluntarily (i.e. unassisted) perform a 90 degrees flexion in the knee.
• Be able to perform the machine exercise (knee extension) planned for the BFR training.
• Danish-speaking.
• No longer travel planned within the intervention period.

You may not qualify if:

• Kellgren \& Lawrence grade 4.
• Bilateral OA-symptoms.
• Prior knee- or hip alloplasty.
• Glucocorticosteroid injection in the knee within the last 6 months.
• Inflammatory arthritis.
• Known neurotic disease such as multiple sclerosis or peripheral neuropathy.
• Prior myocardial infarct or apoplexy, or chest pain during physical activity.
• Other health related or medical conditions which makes it impossible participate in the study.
• Peripheral vascular disease
• Excessive varicose veins
• Prior history of deep venous thrombosis
• Venous insufficiency causing edema in the lower legs
• Systolic blood pressure over 160 mmHg or under 100 mmHg

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Southern Denmark: collaborator
• Gigtforeningen: collaborator
• Sygekassernes Helsefond: collaborator
• AP Moeller Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator
• Praksisfonen: collaborator
• FAPS: collaborator

Study Sites (1)

Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (59)

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MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Finn E Johannsen, MD

  Institute of Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to intervention allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and PhD student

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 29, 2022
• Study Start: January 1, 2022
• Primary Completion: January 15, 2025
• Study Completion: February 14, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)