Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis of Knee; Pain, Joint; Resistance Training; Blood Flow Restriction Exercise; Occlusion Training; Hypertrophy

• Registration Number: NCT04535596
• Lead Sponsor: Istanbul Medipol University Hospital

Brief Summary

Knee osteoarthritis (OA) is a rheumatic disease that causes serious cartilage damage in the knee joint. Moderate physical activity can slow cartilage degeneration in moderate OA stages. Remarkable weakness and atrophy of the quadriceps and hamstrings is a common problem in patients with chronic osteoarthritis, but in arthritis, it may be difficult to achieve strength gains due to the pain caused by heavy load-resistant exercises. Exercising with these high loads may not be possible or may injure painful arthritic knees. For this reason, lately, blood flow restriction exercises have been directed to achieve the same gain by exercising with lower loads by restricting the blood flow with a cuff. We aimed to limit the blood flow in osteoarthritic knees and to provide strength gain and pain reduction provided by conventional exercises given routinely. Our hypothesis in this study is that exercises that blood flow restriction exercises will reduce pain and increase strength as well as conventional exercises.

Detailed Description

Knee osteoarthritis is a rheumatic disease that causes serious cartilage damage in the knee joint. Moderate physical activity can slow cartilage degeneration in moderate OA stages. Remarkable weakness and atrophy of the quadriceps and hamstrings is a common problem in patients with chronic osteoarthritis, but in arthritis, it may be difficult to achieve strength gains due to the pain caused by heavy load-resistant exercises. Exercising with these high loads may not be possible or may injure painful arthritic knees. For this reason, lately, blood flow restricting exercises have been directed to achieve the same gain by exercising with lower loads by restricting the blood flow with a cuff. We aimed to limit the blood flow in osteoarthritic knees and to provide strength gain and pain reduction provided by conventional exercises given routinely. Our hypothesis in this study is that exercises that limit blood flow will reduce pain and increase strength as well as conventional exercises. Forty patients diagnosed with knee osteoarthritis by X-ray will be included in the study. Grade II-III (high rate of exercise therapy) individuals according to the Kellgren Lawrence classification will be included. Patients diagnosed with orthopedics and traumatology will be randomly divided into two groups according to the order of entry through the door. Conventional Exercises that increase muscle strength, flexibility and reduce pain will be included in the first group. In the second group, the same exercises will be used, but during the application, a cuff will be placed on the thigh and the blood flow will be prevented by inflating, therefore, exercises with lower loads will be performed. Exercises will be practiced for 12 weeks and pre-exercise results will be compared within and between groups.

Study Timeline

• Study First Submitted: 2020-08-28
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-02
• Primary Completion: 2022-01-10
• Study Completion: 2022-02-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Participants between the ages of 45-70, diagnosed with knee osteoarthritis according to the criteria of the American College of Rheumatology.
• Participants who stated that the severity of knee pain to be evaluated with Visual Analog Pain Scale (VAS) is between 2-8
• Participants who are voluntaries for the study

Exclusion Criteria

• Participants who have patellar subluxation or dislocation around the knee, who have other sources of knee pain such as bursae, fat pad and a history of knee surgery,
• Those who are in Grade 1 or 4 according to the Kellgren-Lawrence radiographic staging
• Those who have participated in leg weight exercise training in the last 6 months
• Participants who are under the high risk of venous thrombosis (lower extremity surgery, cardiovascular conditions including high blood pressure (> 140/90) in the past 6 months),
• Diabetes, pregnancy, unexplained chest pain or heart disease, fainting or dizziness during physical activity / exercise.
• If exercise is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	12 weeks	Pain intensities which are assessed by visual analogue scale(VAS) divided 10 equal intervals. "0" means no pain and "10" means unbearable pain. Higher scores idicate worse pain intensity.
WOMAC score	12 weeks	score among patients with knee and/or hip osteoarthritis. The Index is self-administered, 24 question, 5-point Likert. Scores range from 0 to 96 for the total WOMAC where higher scores indicate worse function.

Secondary Outcome Measures

Name	Time	Method
Short Form-36 questionnaire	12 weeks	SF-36 quality of life form
high sensitive C-reactive protein (hs-CRP)	12 weeks	hs-CRP(high sensitive C-reactive protein) level
Physical Function	12 weeks	measured by timed up and go test,
Quadriceps muscle strength	4 weeks	peak isometric knee extensor torque measured by myometer.
Quadriceps cross sectional area	12 weeks	Measured by MRI
Circumference of thigh	12 weeks	measured in the same level of quadriceps before and after application.

Trial Locations

Locations (1)

Gizem Ergezen; 🇹🇷 Istanbul, Beykoz, Turkey