A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: Anti-gravity treadmill; Other: Blood flow restriction training + Anti-gravity treadmill

• Registration Number: NCT05728827
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Study Start: 2023-03-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-09
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-gravity treadmill	Anti-gravity treadmill	-
Anti-gravity treadmill + Blood Flow Restriction training	Blood flow restriction training + Anti-gravity treadmill	-

Primary Outcome Measures

Name	Time	Method
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index	Change from Baseline to 6 months	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.

Trial Locations

Locations (1)

Christian Candrian; 🇨🇭 Lugano, Switzerland