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NCT Number: NCT04535596

Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

12 week long strength training exercises for knee

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

  2. WOMAC score

    Time frame: 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 outcomes

  1. high sensitive C-reactive protein (hs-CRP)

    Time frame: 12 weeks

    hs-CRP(high sensitive C-reactive protein) level

  2. Physical Function

    Time frame: 12 weeks

    measured by 6 minute walking test

  3. Physical Function

    Time frame: 12 weeks

    measured by sit-stand test

  4. Physical Function

    Time frame: 12 weeks

    measured by timed up and go test,

  5. Quadriceps muscle strength

    Time frame: 4 weeks

    peak isometric knee extensor torque measured by myometer.

  6. Quadriceps cross sectional area

    Time frame: 12 weeks

    Measured by MRI

  7. Circumference of thigh

    Time frame: 12 weeks

    measured in the same level of quadriceps before and after application.

  8. Short Form-36 questionnaire

    Time frame: 12 weeks

    SF-36 quality of life form

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Comparison of Blood Flow Restriction Exercises With Conservative Exercises in Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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