A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

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

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 Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Blood flow restriction training + Anti-gravity treadmill; Other: Anti-gravity treadmill

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Christian Candrian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-gravity treadmill + Blood Flow Restriction training	Other: Blood flow restriction training + Anti-gravity treadmill; 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.
Active Comparator: Anti-gravity treadmill	Other: Anti-gravity treadmill; The intervention will be applied walking/running on the anti-gravity treadmill.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Investigators: Study Chair: Christian Candrian, MD, EOC

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: ORL-ORT-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No