CClinicalTrials.gg
Active, not recruitingNCT05728827Updated Mar 5, 2026

A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

An interventional study of Blood flow restriction training + Anti-gravity treadmill and Anti-gravity treadmill in Knee Osteoarthritis, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Active, not recruiting at 1 site in Switzerland. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 37 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Anti-gravity treadmill + Blood Flow Restriction training

    Other: Blood flow restriction training + Anti-gravity treadmill

  • Active comparator
    Anti-gravity treadmill

    Other: Anti-gravity treadmill

Interventions

  • OtherBlood 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.

  • OtherAnti-gravity treadmill

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Christian Candrian
    Lugano, 6900, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05728827
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Responsible party
Sponsor
First posted
Feb 15, 2023
Start date
Mar 15, 2023
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Christian Candrian, MD
study chair · EOC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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