Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01797679
• Other study ID #: NFR213335/h10
• Status: Withdrawn
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: January 2020
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Strength Training

• Aerobic Exercise

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Akershus	Hjelp24, Oslo University Hospital, South-Eastern Norway Regional Health Authority, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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