Effects of Blood-flow Restricted Exercise Compared to Standard Rehabilitation in Patients With Knee Osteoarthritis
NCT ID: NCT05437770
Last Updated: 2025-06-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
96 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-01-01
Study Completion Date
2025-02-14
Brief Summary
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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.
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Detailed Description
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Osteoarthritis (OA) is a common disease in Denmark with high socioeconomical costs. Representing the most widespread non-medical and non-operative treatment modality both internationally and in Denmark, knee-OA patients often are offered a combination of patient education, weight loss counseling and physical exercise. In Denmark the GLA:D (Good Life with osteoArthritis in Denmark) concept is a nationwide training paradigm which is a combination of education and supervised neuromuscular exercise (NEMEX). Physical exercise including conventional strength training has shown positive results on OA, however a large proportion of OA-patients are forced to refrain from this type of training to excessive joint- and muscle pain during and following the training sessions.
A more joint protecting type of training (BFR = Blood-Flow Restricted exercise), which are performed using low training load (\<30% of maximum load) and with a reduced blood flow to the working muscles, has shown similar results to conventional heavy strength training. Based on these observations BFR exercise seems to represent an attractive training modality in patients with knee-OA.
The aim of the present study is to investigate the effect of low-intensity BFR exercise on joint pain, muscle mass, and mechanical muscle function compared to SR in adults with knee-OA. A second aim is to investigate if 12 weeks of training is more efficient compared to 8 weeks of training.
Patients diagnosed with knee-OA are eligible to participate. Inclusion takes place via the Institute of Sportsmedicine (ISMC), and the Department of Physical and Occupational Therapy at Bispebjerg Hospital. Patients will be called in for a preparatory examination by one of the attending physicians. At the consultation a standard clinical assessment will be performed and the participant will be examined for meeting the explicit inclusion or exclusion criteria of the study. If the participant after receiving all oral and written information wishes to participate in the study, an informed consent will be obtained. Randomization procedures will be performed. A randomized controlled trial design with two groups; 1) BFR, and 2) Standard rehabilitation. A total sample size of 95 participants are needed when assuming a 20 % dropout.
The intervention period will last 12 consecutive weeks with 2 weekly training sessions at several chosen physiotherapy clinics (standard rehabilitation) and at Bispebjerg Hospital (BFR). Participants in the standard rehabilitation group will be offered participation in the GLA:D programme supervised by GLA:D certified physiotherapists. The BFR group will be trained by instructors who are experienced in BFR exercise. Testing will take place before the intervention period, after 8 weeks of training and at the end of the intervention (12 weeks) except for the muscle biopsies which will take place before the intervention period and at the end (12 weeks). Patient-reported questionnaires will furthermore be assessed 6 months after the intervention period. Patients will be tested at Bispebjerg Hospital for a number of different outcome measures including joint- and muscle pain, functional level and mechanical muscle function (strength and muscle mass).
A more joint protecting type of training (BFR = Blood-Flow Restricted exercise), which are performed using low training load (\<30% of maximum load) and with a reduced blood flow to the working muscles, has shown similar results to conventional heavy strength training. Based on these observations BFR exercise seems to represent an attractive training modality in patients with knee-OA.
The aim of the present study is to investigate the effect of low-intensity BFR exercise on joint pain, muscle mass, and mechanical muscle function compared to SR in adults with knee-OA. A second aim is to investigate if 12 weeks of training is more efficient compared to 8 weeks of training.
Patients diagnosed with knee-OA are eligible to participate. Inclusion takes place via the Institute of Sportsmedicine (ISMC), and the Department of Physical and Occupational Therapy at Bispebjerg Hospital. Patients will be called in for a preparatory examination by one of the attending physicians. At the consultation a standard clinical assessment will be performed and the participant will be examined for meeting the explicit inclusion or exclusion criteria of the study. If the participant after receiving all oral and written information wishes to participate in the study, an informed consent will be obtained. Randomization procedures will be performed. A randomized controlled trial design with two groups; 1) BFR, and 2) Standard rehabilitation. A total sample size of 95 participants are needed when assuming a 20 % dropout.
The intervention period will last 12 consecutive weeks with 2 weekly training sessions at several chosen physiotherapy clinics (standard rehabilitation) and at Bispebjerg Hospital (BFR). Participants in the standard rehabilitation group will be offered participation in the GLA:D programme supervised by GLA:D certified physiotherapists. The BFR group will be trained by instructors who are experienced in BFR exercise. Testing will take place before the intervention period, after 8 weeks of training and at the end of the intervention (12 weeks) except for the muscle biopsies which will take place before the intervention period and at the end (12 weeks). Patient-reported questionnaires will furthermore be assessed 6 months after the intervention period. Patients will be tested at Bispebjerg Hospital for a number of different outcome measures including joint- and muscle pain, functional level and mechanical muscle function (strength and muscle mass).
Conditions
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Osteoarthritis, Knee
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Outcome assessor will be blinded to intervention allocation.
Study Groups
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BFR (Blood-Flow Restricted exercise)
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.
Group Type
EXPERIMENTAL
BFR (Blood-Flow Restricted exercise)
Intervention Type
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).
Standard rehabilitation
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.
Group Type
ACTIVE_COMPARATOR
Standard rehabilitation
Intervention Type
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.
Interventions
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BFR (Blood-Flow Restricted exercise)
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).
Intervention Type
OTHER
Standard rehabilitation
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
Furthermore, it is an exclusion criterium in the following conditions where use of pneumatic occlusion would be considered contraindicated:
* 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
* 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.
Furthermore, it is an exclusion criterium in the following conditions where use of pneumatic occlusion would be considered contraindicated:
* 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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Southern Denmark
OTHER
Sponsor Role
collaborator
Gigtforeningen
OTHER
Sponsor Role
collaborator
Sygekassernes Helsefond
OTHER
Sponsor Role
collaborator
AP Moeller Foundation
OTHER
Sponsor Role
collaborator
Aase and Ejnar Danielsens Foundation
OTHER
Sponsor Role
collaborator
Praksisfonen
UNKNOWN
Sponsor Role
collaborator
FAPS
UNKNOWN
Sponsor Role
collaborator
Bispebjerg Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Brian Sorensen
Principal investigator and PhD student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Finn E Johannsen, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Sports Medicine
Locations
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Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, , Denmark
Site Status
Countries
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Denmark
References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BRS-090288
Identifier Type: -
Identifier Source: org_study_id
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