A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728827
• Other study ID #: ORL-ORT-39
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Sebastiano Nutarelli, MS
• Phone: 0041918117029
• Email: s.nutarelli[@]mail.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Anti-gravity treadmill
The intervention will be applied walking/running on the anti-gravity treadmill.

Locations

Country	Name	City	State
Switzerland	Christian Candrian	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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