Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

NCT01797679 | Withdrawn DMC

• 1 other identifier: NFR213335/h10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Semiquantitative Cartilage Assessment

  One year

Study Arms (3)

Strength Training

OTHER

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

Aerobic exercise

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group will do as usual.

Interventions

Strength Training OTHER

Strength Training

Aerobic Exercise OTHER

Aerobic exercise

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• The Research Council of Norway: collaborator
• Oslo University Hospital: collaborator
• Hjelp24: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Akershus University Hospital

Lorenskog, 1478, Norway

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2017
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)