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Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01797679
Recruitment Status : Withdrawn
First Posted : February 22, 2013
Last Update Posted : October 1, 2013
Sponsor:
Collaborators:
The Research Council of Norway
Oslo University Hospital
Hjelp24
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 RCT 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

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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

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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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT01797679


Locations
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Norway
Akershus University Hospital
Lorenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
The Research Council of Norway
Oslo University Hospital
Hjelp24
South-Eastern Norway Regional Health Authority

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Responsible Party: Hasan Banitalebi, MD, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01797679     History of Changes
Other Study ID Numbers: NFR213335/h10
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Hasan Banitalebi, University Hospital, Akershus:
Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho

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