Performance in Walking in Osteoarthritis Patients (EX-ART)
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
eccentric work
concentric work
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Department of rheumatology, nice university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
concentric work
eccentric work
Arm Description
patient suffering from knee osteoarthritis will follow a concentric work. This training is 2 sessions per week for 6 weeks
patient suffering from knee osteoarthritis will follow an eccentric work. This training is 2 sessions per week for 6 weeks
Outcomes
Primary Outcome Measures
Walking performance
6-minute walk test
Secondary Outcome Measures
Full Information
NCT ID
NCT03167502
First Posted
May 24, 2017
Last Updated
February 6, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03167502
Brief Title
Performance in Walking in Osteoarthritis Patients
Acronym
EX-ART
Official Title
Performance in Walking in Osteoarthritis Patients: the Role of Fatigue and the Effect of an Eccentric Muscle Building Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
September 25, 2019 (Anticipated)
Study Completion Date
December 25, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
concentric work
Arm Type
Active Comparator
Arm Description
patient suffering from knee osteoarthritis will follow a concentric work. This training is 2 sessions per week for 6 weeks
Arm Title
eccentric work
Arm Type
Experimental
Arm Description
patient suffering from knee osteoarthritis will follow an eccentric work. This training is 2 sessions per week for 6 weeks
Intervention Type
Other
Intervention Name(s)
eccentric work
Intervention Description
patient will follow 2 eccentric trainings per week during 6 weeks
Intervention Type
Other
Intervention Name(s)
concentric work
Intervention Description
patient will follow 2 concentric trainings per week during 6 weeks
Primary Outcome Measure Information:
Title
Walking performance
Description
6-minute walk test
Time Frame
after 6 training weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian H ROUX, PhD
Phone
0492035491
Email
roux.c2@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian H ROUX, PhD
Organizational Affiliation
service de Rhumatologie, CHU de NICE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of rheumatology, nice university hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
christian hubert roux, MD
Email
roux.c2@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Christian H Roux, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35832351
Citation
Trojani MC, Chorin F, Gerus P, Breuil V, Michel C, Guis S, Bendahan D, Roux C. Concentric or eccentric physical activity for patients with symptomatic osteoarthritis of the knee: a randomized prospective study. Ther Adv Musculoskelet Dis. 2022 Jul 7;14:1759720X221102805. doi: 10.1177/1759720X221102805. eCollection 2022.
Results Reference
derived
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Performance in Walking in Osteoarthritis Patients
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