A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

NCT ID: NCT05728827

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-gravity treadmill + Blood Flow Restriction training

Group Type EXPERIMENTAL

Blood flow restriction training + Anti-gravity treadmill

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Anti-gravity treadmill

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Anti-gravity treadmill

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Candrian, MD

Role: STUDY_CHAIR

EOC

Locations

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Christian Candrian

Lugano, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Sebastiano Nutarelli, MS

Role: CONTACT

0041918117029

Facility Contacts

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Christian Candrian, MD

Role: primary

+41 (0) 91 811 61 23

Other Identifiers

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ORL-ORT-39

Identifier Type: -

Identifier Source: org_study_id

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