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Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01682980
Recruitment Status : Recruiting
First Posted : September 11, 2012
Last Update Posted : October 23, 2014
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain,physical function and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises compared to another intervention group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Other: Strength training Other: Aerobic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes and Structural Changes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.
Study Start Date : March 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Other: Strength training
The strength training will be delivered 2-3 times per week for 12 weeks, 5-8 repetitions maximum in 3 series. The patients must warm up 5 minutes on an ergometer cycle. The following muscle groups will be trained: Quadriceps and hamstrings, hip muscles (abductors and extensors), calf muscles. A home exercise program will be delivered including one leg exercises and balance exercises. Progression will follow a 2+ principle. For instance, when the study participant is able to perform 2 more repetitions, more loads are required.

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 75% of maximal heart rate (calculated with formula for maximal heart rate reserve).
Other: Aerobic exercise
The aerobic exercise program include ergometer cycling for at least 45 minutes 2-3 times a week on 75-80% of max heart rate will be required.

No Intervention: Control group
The control group will do as usual.

Primary Outcome Measures :
  1. Knee-related quality of life [ Time Frame: 1 year ]
    Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale).

Secondary Outcome Measures :
  1. Knee function [ Time Frame: 1 year ]
    The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, activities of daily living (ADL), function in sports and recreation and knee-related (QOL).

  2. Health-related quality of life [ Time Frame: 1 year ]
  3. Radiographic osteoarthritis progression [ Time Frame: 2 years ]
    Conventional x-rays will be used to assess radiographic progression of osteoarthritis

Other Outcome Measures:
  1. Cartilage morphology measures (MRI) [ Time Frame: 1 year ]
    MRI techniques including T2 mapping and T1rho sequences.

  2. Isokinetic muscle strength [ Time Frame: 1 year ]
  3. Maximal oxygen consumption (VO2max) [ Time Frame: 1 year ]
  4. Self-efficacy for pain (ASES) [ Time Frame: 1 year ]
  5. Total knee replacement [ Time Frame: 5 years ]
    We will register continuously numbers of total knee replacements during the follow-up years.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women and men aged 35-70 years
  • Clinical knee OA according to the American College of Rheumatology Clinical Criteria
  • 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 Oslo University Hospital, radiographic department)
  • Not speaking Norwegian language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682980

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Contact: Britt Elin Øiestad, PhD +4792803089
Contact: May Arna Risberg, PhD

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Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Britt Elin Øiestad, PhD    +4792803089   
Principal Investigator: Britt Elin Øiestad, PhD         
Sub-Investigator: May Arna Risberg, PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
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Study Chair: May Arna Risberg, PhD Oslo University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oslo University Hospital Identifier: NCT01682980     History of Changes
Other Study ID Numbers: 2012/334
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by Oslo University Hospital:
Cartilage quality

Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases