Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis
Primary Purpose
Osteoarthritis of Knee, Blood Flow Restriction Exercise, Resistance Training
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
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
Sites / Locations
- Gizem Ergezen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional Exercises
Blood Flof Restriction Exercises
Arm Description
12 week long strength training exercise with the higher loading (%70-80 of 1 Repetitive Maximum)
12 week long strength training exercise with the lower loading (%20-30 of 1 Repetitive Maximum) by using cuff around the thigh
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
high sensitive C-reactive protein (hs-CRP)
hs-CRP(high sensitive C-reactive protein) level
Physical Function
measured by 6 minute walking test
Physical Function
measured by sit-stand test
Physical Function
measured by timed up and go test,
Quadriceps muscle strength
peak isometric knee extensor torque measured by myometer.
Quadriceps cross sectional area
Measured by MRI
Circumference of thigh
measured in the same level of quadriceps before and after application.
Short Form-36 questionnaire
SF-36 quality of life form
Full Information
NCT ID
NCT04535596
First Posted
August 28, 2020
Last Updated
March 14, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04535596
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee, Blood Flow Restriction Exercise, Resistance Training, Occlusion Training, Pain, Joint, Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Exercises
Arm Type
Experimental
Arm Description
12 week long strength training exercise with the higher loading (%70-80 of 1 Repetitive Maximum)
Arm Title
Blood Flof Restriction Exercises
Arm Type
Experimental
Arm Description
12 week long strength training exercise with the lower loading (%20-30 of 1 Repetitive Maximum) by using cuff around the thigh
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
12 week long strength training exercises for knee
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
12 weeks
Title
WOMAC score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
high sensitive C-reactive protein (hs-CRP)
Description
hs-CRP(high sensitive C-reactive protein) level
Time Frame
12 weeks
Title
Physical Function
Description
measured by 6 minute walking test
Time Frame
12 weeks
Title
Physical Function
Description
measured by sit-stand test
Time Frame
12 weeks
Title
Physical Function
Description
measured by timed up and go test,
Time Frame
12 weeks
Title
Quadriceps muscle strength
Description
peak isometric knee extensor torque measured by myometer.
Time Frame
4 weeks
Title
Quadriceps cross sectional area
Description
Measured by MRI
Time Frame
12 weeks
Title
Circumference of thigh
Description
measured in the same level of quadriceps before and after application.
Time Frame
12 weeks
Title
Short Form-36 questionnaire
Description
SF-36 quality of life form
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, MSc
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustafa Sahin, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Candan Algun, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Gizem Ergezen
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 3 months after publication
Learn more about this trial
Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis
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