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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01586130
Other study ID # CHU-0114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date December 31, 2018

Study information

Verified date January 2013
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises. Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode. The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.


Description:

Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises. Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode. The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2018
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Patient male or female, age ranging from 40 to 70 years old - Patient suffering from one-sided knee O.A. regarding criteria of the American College of Rheumatology (A.C.R.), with radiologic score ranging from 2 to 3 according to the Kellgren & Lawrence classification. - Patient receiving medical support - Patient that did not receive any infiltration on knee within two months before randomisation. - Patient free from any disease that could be a contraindication to the study treatment - Patient able to understand the protocol and willing to comply with its rules. - Patient willing to give consent. - Patient affiliated to the french social secu Exclusion Criteria: - Patient carrying prosthesis. - Patient suffering from inflammatory arthritis, or flare of arthritis. - Patient suffering from symptomatic patellofemoral osteoarthritis. - Patient suffering from cardio-vascular or pneumologic disease that could a contraindication to the study treatment. - Patient suffering from any pathology that could cause muscular weakness (myopathy, neuropathy, hemiplegia...)

Study Design


Intervention

Other:
Exercise in eccentric or concentric mode
In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference of peak torque of quadriceps 6 months after treatment start
Secondary Walk speed (50 meters and 200 meters) at day 1, 6 weeks, and 6 months :
Secondary Knee pain (via analogic visual scales) at day 1, 6 weeks, and 6 months
Secondary Posture parameters (posturography) at day 1, 6 weeks, and 6 months
Secondary WOMAC Scores at day 1, 6 weeks, and 6 months
Secondary Knee perimeter at day 1, 6 weeks, and 6 months
Secondary Knee range of motion (goniometer) at day 1, 6 weeks, and 6 months
Secondary Kellgren & Lawrence scores at day 1, 6 weeks, and 6 months
See also
  Status Clinical Trial Phase
Completed NCT01806207 - Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis Phase 4