Back to resultsARTIST: ARThrose Intervention STandardisée (ARTIST)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Education, weight reduction and physical exercise
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- symptomatic and ambulatory patients
- suffering from knee osteoarthritis (ACR criteria)
- 25<BMI<35
- signed informed consent
Exclusion Criteria:
- need to surgery within 6 next months
- co-morbidity
Sites / Locations
Outcomes
Primary Outcome Measures
Weight
Physical Exercise in Leisure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00462319
Brief Title
ARTIST: ARThrose Intervention STandardisée
Acronym
ARTIST
Official Title
Evaluation of Standardized Management of Knee Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Almirall, SAS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Education, weight reduction and physical exercise
Primary Outcome Measure Information:
Title
Weight
Title
Physical Exercise in Leisure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic and ambulatory patients
suffering from knee osteoarthritis (ACR criteria)
25<BMI<35
signed informed consent
Exclusion Criteria:
need to surgery within 6 next months
co-morbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Marc FLIPO
Organizational Affiliation
Hôpital Salengro - Lille, France
Official's Role
Principal Investigator
Facility Information:
City
Paris
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
11014340
Citation
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
Results Reference
background
PubMed Identifier
15986358
Citation
Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.
Results Reference
background
PubMed Identifier
19237406
Citation
Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.
Results Reference
derived
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ARTIST: ARThrose Intervention STandardisée
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