Osteoarthritis, Knee Clinical Trial
Official title:
Effects of Low-intensity Blood-flow Restricted Exercise Compared to Standard Rehabilitation in Patients With Knee Osteoarthritis - a Randomized Controlled Trial
Verified date | November 2022 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | Aase and Ejnar Danielsens Foundation, AP Moeller Foundation, FAPS, Gigtforeningen, Praksisfonen, Sygekassernes Helsefond, University of Southern Denmark |
Denmark,
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* Note: There are 59 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Myofiber Cross-Sectional Area (CSA) | Quadriceps myofiber cross-sectional area will be measured using a GE Logiq E10 Logic View ultrasound to generate panoramic CSA images. Orientated in the axial-plane, the ultrasound probe is positioned perpendicularly, and a water-based gel is used to promote acoustic contact between the skin and the probe. The probe is moved manually with a slow and continuous movement from the lateral to the medial part of quadriceps along a marked line on the skin. The anatomical site for all measurements will be at 50% of the distance between the lateral condyle and greater trochanter of the femur. | Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period) | |
Secondary | Pain Pressure Threshold (PPT) | PPT is measured by a handheld pain pressure algometer at three different locations bilaterally. Most painful area in the medial joint line, tibialis anterior, and the muscle belly of extensor carpi radialis. | Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period) | |
Secondary | Maximal Voluntary Isometric Contraction (MVIC) | MVIC of the knee extensors is obtained during static knee extension in a KinCom, isokinetic dynamometer, at a knee joint angle of 70 degrees (0 degrees = full knee extension). | Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period) | |
Secondary | Rate of Force Development (RFD) | RFD of the knee extensors is obtained during static knee extension in a KinCom, isokinetic dynamometer, at a knee joint angle of 70 degrees (0 degrees = full knee extension). | Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period) | |
Secondary | 4x10m Fast-Paced Walk Test (40m-FWT) | The 40m-FWT is a test of walking speed over short distances and changing direction during walking. It measures the total time it takes to walk 4 * 10 m excluding turns (m/s). | At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period) | |
Secondary | 30-second Chair Stand Test (30-s CST) | The 30-s CST is used for testing leg strength and endurance. The 30-s CST will be assessed using a chair (seat height: 43-44 cm) with armrests. The 30-s CST measures the number of sit-to-stand repetitions completed within 30-s. | At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period). | |
Secondary | Stair Climb Test (SCT) | The SCT involves ascending and descending 10 stairs measuring 18 cm rise / 92 cm width. Each participant is asked to ascend/descend the stairs at their ''natural'' pace (without resting). One trial to ascend and descend is timed and recorded electronically. | At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period). | |
Secondary | Myocellular component (Stem cells) assessed using muscle biopsies | Muscle biopsies will be obtained for determination of important myocellular components (number of muscular stem cells). It will be assessed by obtaining needle biopsies (100-150 mg). The biopsies will be obtained unilaterally from the middle portion of the vastus lateralis muscle using the percutaneous needle biopsy technique of Bergström. | Baseline (0 weeks) and 12 weeks (the end of the intervention period) | |
Secondary | Myocellular component (Fiber area) assessed using muscle biopsies | Muscle biopsies will be obtained for determination of important myocellular components (fiber area in diameter: µm2). It will be assessed by obtaining needle biopsies (100-150 mg). The biopsies will be obtained unilaterally from the middle portion of the vastus lateralis muscle using the percutaneous needle biopsy technique of Bergström. | Baseline (0 weeks) and 12 weeks (the end of the intervention period) | |
Secondary | Myocellular component (Myonuclei) assessed using muscle biopsies | Muscle biopsies will be obtained for determination of important myocellular components (number of myonuclei). It will be assessed by obtaining needle biopsies (100-150 mg). The biopsies will be obtained unilaterally from the middle portion of the vastus lateralis muscle using the percutaneous needle biopsy technique of Bergström. | Baseline (0 weeks) and 12 weeks (the end of the intervention period) | |
Secondary | Maximal lower limb muscle power | Explosive lower limb muscle power will be assessed during a single-legged extensor power-rig. Subjects will be seated in the power-rig chair and pushes away the footplate connected to a flywheel as hard and fast as possible. | Baseline (0 weeks), 8 weeks and 12 weeks (the end of the intervention period) | |
Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | 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). A normalized score for the total KOOS score will be calculated and reported, ranging from zero (extreme symptoms) to 100 (no symptoms). | At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period) and 6 months after the intervention period. | |
Secondary | Oxford Knee Score | The Oxford Knee Score is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. Each question is scored from 0-4 where four is the best outcome and total scores range from 0 (poorest function) to 48 (maximal function). | At baseline (0 weeks), 8 weeks, 12 weeks (the end of the intervention period) and 6 months after the intervention period. |
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