Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophy; Resistance Training; Osteoarthritis of Knee; Pain, Joint; Blood Flow Restriction Exercise; Occlusion Training
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34810
      • Gizem Ergezen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional Exercises; 12 week long strength training exercise with the higher loading (%70-80 of 1 Repetitive Maximum)	Other: Exercise; 12 week long strength training exercises for knee
EXPERIMENTAL: Blood Flof Restriction Exercises; 12 week long strength training exercise with the lower loading (%20-30 of 1 Repetitive Maximum) by using cuff around the thigh	Other: Exercise; 12 week long strength training exercises for knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Mustafa Sahin, PhD, Medipol University; Study Chair: Candan Algun, PhD, Medipol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): January 10, 2022
• Study Completion (ACTUAL): February 11, 2022

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (ACTUAL): September 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pathological Conditions, Anatomical; Osteoarthritis; Arthralgia; Osteoarthritis, Knee; Hypertrophy
• Other Study ID Numbers: 10840098-722.02-E.34224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 3 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No