Performance in Walking in Osteoarthritis Patients (EX-ART)

April 10, 2024 updated by: Centre Hospitalier Universitaire de Nice

Performance in Walking in Osteoarthritis Patients: the Role of Fatigue and the Effect of an Eccentric Muscle Building Program

Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This is a randomized, interventional trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement, the interest of a work supervised by a sports coach to maintain activity over time and to study the effect of this activity at the muscular level. The main objective is to study the effect of an eccentric muscle strengthening program on walking performance in osteoarthritis patients. The secondary objectives are to study: the effect of fatigue on walking, the relationship between fatigue and the level of physical activity, the effect of training on perceived fatigue and the effect of training on the function and at muscular level. This is a randomized, interventional trial. 40 subjects are planned. Inclusion criteria include: age 40-85 years, KL 2 and 3. The subjects are divided into two groups to perform either eccentric or concentric work. 2 sessions per week for 6 weeks. At baseline and at the end of the study a clinical evaluation and MRI will be carried out for evaluation of the criteria of judgment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • Department of rheumatology, nice university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Autonomous subjects aged 40 to 85
  • Subjects meeting ACR criteria for gonarthrosis
  • Subjects with a score of Kellgren and Lawrence at least one knee greater than or equal to 2
  • Signature of consent form
  • Subjects affiliated to social security

Exclusion Criteria:

Subject with a Kellgren and Lawrence stadium at 4 for at least one of his two knees

  • Subjects with symptomatic femoro-patellar arthrosis
  • Subject with a pathology that makes walking testing impossible.
  • Non-autonomous subjects, with a pathology impairing walking
  • Subjects with symptomatic osteoarthritis of the hip and / or with a hip or knee prosthesis
  • Subject incapable of signing consent and unable to understand information leaflet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: concentric work
patient suffering from knee osteoarthritis will follow a concentric work. This training is 2 sessions per week for 6 weeks
Other: concentric work
patient will follow 2 concentric trainings per week during 6 weeks
Experimental: eccentric work
patient suffering from knee osteoarthritis will follow an eccentric work. This training is 2 sessions per week for 6 weeks
Other: eccentric work
patient will follow 2 eccentric trainings per week during 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking performance
Time Frame: after 6 training weeks
6-minute walk test
after 6 training weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Christian H ROUX, PhD, service de Rhumatologie, CHU de NICE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Actual)

November 25, 2017

Study Completion (Actual)

June 17, 2019

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-AOIP-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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