A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

N/AActive Not RecruitingNCT05728827

Ente Ospedaliero Cantonale, Bellinzona70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age included between 45 and 80 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 81 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.

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline to 6 months