A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

Study Overview
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Brief Summary
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The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group). Participants will be divided as follows: Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.

Official Title
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Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Blood flow restriction training + Anti-gravity treadmill
* Other: Anti-gravity treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age included between 45 and 70 years old Patients with knee OA diagnosed by a medical doctor with a radiological confirmation Patients able to provide informed consent and follow all the study procedures as indicated by the protocol Informed Consent as documented by signature Exclusion Criteria: Younger than 44 years old or older than 71 years old included Known drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. Participation in another study with an investigational drug within the 30 days preceding and during the present study Treatment with an injective approach in the previous 3 month Surgical treatment in the previous 12 months.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-gravity treadmill + Blood Flow Restriction training<br> | Other: Blood flow restriction training + Anti-gravity treadmill<br>* Blood flow restriction training is administered via straps applied to the proximal limb with the possibility to adjust the applied occlusion pressure in order to prevent venous return leaving the arterial flow partially free. The consequent blood pooling causes a reduction in tissue saturation with oxidative stress and an increased growth factors secretion. The intervention will be applied while walking/running on the anti-gravity treadmill.<br>|
| Active Comparator: Anti-gravity treadmill<br> | Other: Anti-gravity treadmill<br>* The intervention will be applied walking/running on the anti-gravity treadmill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index | Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis. | Change from Baseline to 6 months |