Clinical trial NCT04535596: Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis
Official title: Comparison of Blood Flow Restriction Exercises With Conservative Exercises in Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Blood Flow Restriction Exercise
Resistance Training
Occlusion Training
Pain, Joint
Hypertrophy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 12 weeks
measure: WOMAC score
timeFrame: 12 weeks
Secondary outcomes:
measure: high sensitive C-reactive protein (hs-CRP)
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Quadriceps muscle strength
timeFrame: 4 weeks
measure: Quadriceps cross sectional area
timeFrame: 12 weeks
measure: Circumference of thigh
timeFrame: 12 weeks
measure: Short Form-36 questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gizem Ergezen
state: Beykoz
Study officials:
affiliation: Medipol University
name: Gizem Ergezen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Mustafa Sahin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Candan Algun, PhD
role: STUDY_CHAIR
References: