Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis

• ClinicalTrials.gov Identifier: NCT04535596
• Recruitment Status: Recruiting
• First Posted: September 2, 2020
• Last Update Posted: May 28, 2021
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): gizem ergezen, Istanbul Medipol University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of Knee; Blood Flow Restriction Exercise; Resistance Training; Occlusion Training; Pain, Joint; Hypertrophy	Other: Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Blood Flow Restriction Exercises With Conservative Exercises in Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: April 1, 2022
• Estimated Study Completion Date: June 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Gizem Ergezen, MSc; +905347098414; gergezen@medipol.edu.tr

Contact: Mustafa Sahin, PhD; +905327098414; msahin@medipol.edu.tr

Locations

Turkey

Gizem Ergezen; Recruiting

Istanbul, Beykoz, Turkey, 34810

Contact: Gizem Ergezen, MSc 05347098414 ext 2520 gergezen@medipol.edu.tr

Principal Investigator: Gizem Ergezen, MSc

Sponsors and Collaborators

Istanbul Medipol University Hospital

Investigators

• Principal Investigator: Gizem Ergezen, MSc; Medipol University
• Principal Investigator: Mustafa Sahin, PhD; Medipol University
• Study Chair: Candan Algun, PhD; Medipol University

More Information

• Responsible Party: gizem ergezen, Gizem Ergezen, MSc, Physiotherapist, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT04535596
• Other Study ID Numbers: 10840098-722.02-E.34224
• First Posted: September 2, 2020
• Last Update Posted: May 28, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: all IPD that underlie results in a publication
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: starting 3 months after publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthralgia; Hypertrophy; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathological Conditions, Anatomical; Pain; Neurologic Manifestations