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Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Strength Training
Aerobic Exercise
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

No Intervention

Arm Label

Strength Training

Aerobic exercise

Control Group

Arm Description

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

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.

The control group will do as usual.

Outcomes

Primary Outcome Measures

Qualitative Cartilage Morphology Assessment
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

Semiquantitative Cartilage Assessment
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.

Full Information

First Posted
February 21, 2013
Last Updated
January 10, 2020
Sponsor
University Hospital, Akershus
Collaborators
The Research Council of Norway, Oslo University Hospital, Hjelp24, South-Eastern Norway Regional Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01797679
Brief Title
Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of agreement between the participants and lack og funding
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
The Research Council of Norway, Oslo University Hospital, Hjelp24, South-Eastern Norway Regional Health Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength Training
Arm Type
Other
Arm Description
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
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will do as usual.
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Primary Outcome Measure Information:
Title
Qualitative Cartilage Morphology Assessment
Description
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)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Semiquantitative Cartilage Assessment
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

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