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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE February 22, 2013
Last Update Posted Date October 1, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01797679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Other: Strength Training
  • Other: Aerobic Exercise
Study Arms  ICMJE
  • 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

    Intervention: 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.
    Intervention: Other: Aerobic Exercise
  • No Intervention: Control Group
    The control group will do as usual.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 30, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
207
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01797679
Other Study ID Numbers  ICMJE NFR213335/h10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hasan Banitalebi, University Hospital, Akershus
Study Sponsor  ICMJE University Hospital, Akershus
Collaborators  ICMJE
  • The Research Council of Norway
  • Oslo University Hospital
  • Hjelp24
  • South-Eastern Norway Regional Health Authority
Investigators  ICMJE Not Provided
PRS Account University Hospital, Akershus
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP