Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Strength Training; Other: Aerobic Exercise

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lorenskog, Norway, 1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One year

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Oslo University Hospital; The Research Council of Norway; South-Eastern Norway Regional Health Authority; Hjelp24

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: NFR213335/h10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No