Exercise With Blood Flow Restriction in Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.

Official Title
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Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: BFR resistance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women above 55 years old. diagnosed with severe knee osteoarthritis. scheduled for unilateral TKA surgery in a local hospital during 2021- 2022. Exclusion Criteria: pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities). another hip or knee joint replacement in the previous year. any medical condition in which exercise was contraindicated. participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study. history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo<br>Knee extensions with 30% 1RM and no occlusion pressure. | Other: BFR resistance exercise<br>* 4 sets (30, 15, 15, 15 reps).<br>|
| Experimental: BFR at 40% AOP<br>Knee extensions with 30% 1RM and BFR at 40% AOP. | Other: BFR resistance exercise<br>* 4 sets (30, 15, 15, 15 reps).<br>|
| Experimental: BFR at 80% AOP<br>Knee extensions with 30% 1RM and BFR at 80% AOP. | Other: BFR resistance exercise<br>* 4 sets (30, 15, 15, 15 reps).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10) | Change from baseline to the end of the session, and the change between the treatment group and the placebo group. | Pre exercise, immediate post set, immediate post session, and 10 minutes after session. | 
| Pressure pain thresholds | Change from baseline to the end of the session, and the change between the treatment group and the placebo group. | Pre exercise, immediate post session, and 10 minutes after session. | 
| HDsEMG | Change between baseline and exercise, and the change between the treatment group and the placebo group. | During each experimental session and during each exercise condition. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale of Kinesiophobia (TSK 11) | Its score range is 11-44, with higher scores reflecting worse condition. | Pre session. | 
| Pain Catastrophizing Scale (PCS) | People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition. | Pre session. | 
| Chronic Pain Self-Efficacy Scale (CPSS) | The Chronic Pain Self-Efficacy Scale (CPSS) is designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. The CPSS measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. A total score is yielded (ranging from 220-2200), with higher scores reflecting a better condition. | Pre session. | 
| WOMAC questionaire for patients with hip or knee osteoarthritis. | The WOMAC is a disease-specific self-administered questionnaire for patients with hip or knee osteoarthritis. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). For each item, it uses a Likert scale with five response levels, representing different degrees of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the WOMAC is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition. | Pre session. | 
| Heart Rate | Change from baseline to the end of the session, and the change between the treatment group and the placebo group. | Pre exercise, immediate post set, immediate post session, and 10 minutes after session. | 
| Rating of perceived exertion (RPE) based on Borg's CR10 scale | The Borg CR10 scale is a tool for measuring an individual's effort and exertion during physical work. It is a very simple numerical list from 0 (no exertion at all) to 10 (maximal intensity of activity). Participants are asked to rate their exertion on the scale during the activity, combining all sensations and feelings of physical stress and fatigue. They are told to disregard any one factor such as leg pain or shortness of breath but to try to focus on the whole feeling of exertion. | Immediate post exercise. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training