Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

NCT ID: NCT01671917

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-04
• Study Completion Date: 2017-11-29

Brief Summary

The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

Detailed Description

Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and balance, and cardio respiratory deconditioning that contribute to alter abilities to perform activities of daily living. It is the principal indication for total knee arthroplasty (TKA). Patients' functional state and pain level are generally improved after TKA and the physical and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of stay at surgery departments and promoting return at home after TKA are recommended. The recommendations of the Health Authority in France (HAS) and the new law of finance for French clinics contribute to shorter hospital stays and to restrain the conditions of admission to Physical Medicine and Rehabilitation department after TKA.Exercise and education programs conducted before TKA could help better prepare patients for surgery, improve functional outcome and accelerate functional recovery after surgery thus reducing the length of stay in orthopedic departments and facilitate return to home (directly or after a stay in PMR departments). The type of program necessary to achieve those goals remains to be defined.A systematic review of the literature associated with an analysis of practices about the relevance of rehabilitation programs before TKA, concluded that the implementation of such programs before TKA was likely to reduce the length of stay in surgery departments and improve the rate of direct return to home after surgery but that high quality trials were lacking. It also suggested that association of exercise programs with educational ones could be more effective than exercise or education alone, particularly for fragile patients with impaired functional capacity, co-morbidities and/or social problems.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Educational and exercise program

Group Type: EXPERIMENTAL

Educational and exercise program

Intervention Type: OTHER

• 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement
• 4 (twice a week) sessions of an exercise programme lasting 1 hour

Usual care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.

Interventions

Educational and exercise program

• 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement
• 4 (twice a week) sessions of an exercise programme lasting 1 hour

Intervention Type: OTHER

Usual care

Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female aged 50 to 85 years
• Patient suffering from knee osteoarthritis according to ACR for which a total knee arthroplasty is scheduled
• Preliminary medical examination whose results will be transmitted to the patient
• Patient giving his informed consent to participate in the study
• Patient affiliated to or beneficiary of social insurance

Exclusion Criteria

• Patients institutionalized
• Patients who have already received an ipsilateral total knee arthroplasty
• Patients with chronic inflammatory arthritis
• Cognitive or behavioral disorders making assessment impossible
• Inability to speak and write French
• TKA indicated for other reason than osteoarthritis

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Rannou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Descartes University, INSERM

Pascal Richette, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Lariboisière

Emmanuel Coudeyre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Cochin

Paris, , France

Countries

France

References

Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.

Reference Type: BACKGROUND

PMID: 35262716 (View on PubMed)

Other Identifiers

AOM 10042

Identifier Type: -

Identifier Source: org_study_id