Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01797679
Recruitment Status : Withdrawn (Lack of agreement between the participants and lack og funding)
First Posted : February 22, 2013
Last Update Posted : January 14, 2020
The Research Council of Norway
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Hasan Banitalebi, University Hospital, Akershus

Brief Summary:
This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Strength Training Other: Aerobic Exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial
Study Start Date : March 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Strength Training

The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.

Intervention: Other: Strength training

Other: Strength Training
Experimental: Aerobic exercise
The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 85% of maximal heart rate.
Other: Aerobic Exercise
No Intervention: Control Group
The control group will do as usual.

Primary Outcome Measures :
  1. Qualitative Cartilage Morphology Assessment [ Time Frame: One year ]
    Indirect cartilage morphology will by assessed by X-ray Direct cartilage morphology will be assessed by MRI morphometry The biochemical composition of the cartilage will be assessed by relaxometry (T2 and T1 rho relaxation times)

Secondary Outcome Measures :
  1. Semiquantitative Cartilage Assessment [ Time Frame: One year ]
    Using semiquantitative techniques, the clinical manifestations of osteoarthritis assessed by MRI such as: cartilage lesions and bone marrow lesions will be assessed and quantified by MRI.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women and men aged 45-65 years
  • Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
  • Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

  • Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
  • Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
  • Known coronary heart diseases or cancer
  • Body mass index > 35
  • Scheduled for surgery in any joint
  • Known mental or psychologic diseases
  • Known drug abuse
  • Persons who already perform sports related moderate physical activity more than two times a week
  • Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital)
  • Not speaking Norwegian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01797679

Layout table for location information
Akershus University Hospital
Lorenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
The Research Council of Norway
Oslo University Hospital
South-Eastern Norway Regional Health Authority

Layout table for additonal information
Responsible Party: Hasan Banitalebi, Radiologist, University Hospital, Akershus Identifier: NCT01797679    
Other Study ID Numbers: NFR213335/h10
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hasan Banitalebi, University Hospital, Akershus:
Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases