Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

Resistance Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535596
• Other study ID #: 10840098-722.02-E.34224
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 11, 2022

Study information

• Verified date: March 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 11, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Blood Flow Restriction Exercise
• Hypertrophy
• Occlusion Training
• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee
• Pain, Joint
• Resistance Training

Intervention

Other:
• Exercise
12 week long strength training exercises for knee

Locations

Country	Name	City	State
Turkey	Gizem Ergezen	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	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.	12 weeks
Primary	WOMAC score	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.	12 weeks
Secondary	high sensitive C-reactive protein (hs-CRP)	hs-CRP(high sensitive C-reactive protein) level	12 weeks
Secondary	Physical Function	measured by 6 minute walking test	12 weeks
Secondary	Physical Function	measured by sit-stand test	12 weeks
Secondary	Physical Function	measured by timed up and go test,	12 weeks
Secondary	Quadriceps muscle strength	peak isometric knee extensor torque measured by myometer.	4 weeks
Secondary	Quadriceps cross sectional area	Measured by MRI	12 weeks
Secondary	Circumference of thigh	measured in the same level of quadriceps before and after application.	12 weeks
Secondary	Short Form-36 questionnaire	SF-36 quality of life form	12 weeks