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Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis (ISOGO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01586130
First received: February 16, 2012
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Unilateral Knee Osteoarthritis
Other: Exercise in eccentric or concentric mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Difference of peak torque of quadriceps [ Time Frame: 6 months after treatment start ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Walk speed (50 meters and 200 meters) [ Time Frame: at day 1, 6 weeks, and 6 months : ] [ Designated as safety issue: Yes ]
  • Knee pain (via analogic visual scales) [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]
  • Posture parameters (posturography) [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]
  • WOMAC Scores [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]
  • Knee perimeter [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]
  • Knee range of motion (goniometer) [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]
  • Kellgren & Lawrence scores [ Time Frame: at day 1, 6 weeks, and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
isokinetic exercises in eccentric mode 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.
isokinetic exercises in concentric mode 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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...)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586130

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel COUDEYRE University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01586130     History of Changes
Other Study ID Numbers: CHU-0114 
Study First Received: February 16, 2012
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Knee Osteoarthritis
Exercise
Isokinetic
Muscle strength
Rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on December 07, 2016