NCT05728827

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
4mo left

Started Mar 2023

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

February 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

February 3, 2023

Last Update Submit

March 3, 2026

Conditions

Knee Osteoarthritis

Outcome Measures

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.

    Change from Baseline to 6 months

Study Arms (2)

Anti-gravity treadmill + Blood Flow Restriction training

EXPERIMENTAL
Other: Blood flow restriction training + Anti-gravity treadmill

Anti-gravity treadmill

ACTIVE COMPARATOR
Other: Anti-gravity treadmill

Interventions

Blood flow restriction training + Anti-gravity treadmillOTHER

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 + Blood Flow Restriction training
Anti-gravity treadmillOTHER

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

Anti-gravity treadmill

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Candrian

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Christian Candrian, MD

    EOC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 15, 2023

Study Start

March 15, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)