NCT05437770

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

Effects of Low-intensity Blood-flow Restricted Exercise Compared to Standard Rehabilitation in Patients With Knee Osteoarthritis - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
OTHER	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).
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-15
• Completion: 2025-02-14
• First posted: 2022-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: Denmark