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Influence of Weight Loss or Exercise on Cartilage in Obese Knee Osteoarthritis Patients (CAROT)

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. Read our disclaimer for details. Identifier: NCT00655941
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : January 6, 2012
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Weight Plan Limited
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

Brief Summary:

Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.

The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.

There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial has two phases, the first (16 weeks) consisting of a dietary intervention with low-energy diet and the second (52 weeks) a randomized, three group (each n>50 patients) controlled study of maintenance of weight loss by either continuing dietary instruction, exercise, or a control group. The hypothesis is that maintenance of an initially induced weight loss is dependent on attention rather than any specific therapy.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Obesity Behavioral: Dietary instruction Other: Exercise Not Applicable

Detailed Description:
Any patient with osteoarthritis (OA)of the knee and concomitant obesity will be considered for participation. Eligible for this study will be patients with radiographical knee OA. Exclusion criteria are recent or planned knee operations, alloplasties in both knees, ongoing or planned alternative interventions against obesity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Weight Loss or Exercise on CARtilage in Obese Knee Osteoarthritis Patients: a Randomized Controlled Trial (CAROT).
Study Start Date : April 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Dietary instruction (low-energy diet. This is given by instructions in groups of 8
Behavioral: Dietary instruction
Weekly instruction by dieticians
Other Name: The Cambridge Programme

Active Comparator: 2
Other: Exercise
Supervised exercise in groups

No Intervention: 3

Primary Outcome Measures :
  1. Pain [ Time Frame: 16 weeks, 68 weeks ]
  2. OMERACT-OARSI response criterion [ Time Frame: 16 weeks, 68 weeks ]

Secondary Outcome Measures :
  1. Weight change [ Time Frame: 8 weeks, 16 weeks, 68 weeks ]
  2. Gait analysis [ Time Frame: 16 weeks, 68 weeks ]
  3. MRI [ Time Frame: 16 weeks, 68 weeks ]
  4. Ultrasound [ Time Frame: 16 weeks, 68 weeks ]
  5. Collagen markers [ Time Frame: 16 weeks, 68 weeks ]
  6. Metabolic syndrome [ Time Frame: 8 weeks, 16 weeks, 68 weeks ]
  7. KOOS [ Time Frame: 16 weeks, 68 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI >=30
  • Radiographical knee OA
  • Age >=50
  • Spoken Danish
  • Motivated for weight loss

Exclusion Criteria:

  • Bilateral Alloplasty of the knees
  • Ongoing or planned surgery
  • Ongoing or planned alternative weight loss programme
  • Intellectual disability

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): NCT00655941

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The Parker Institute, Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Henning Bliddal
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Weight Plan Limited
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Study Director: Henning Bliddal, Professor,MD The Parker Institute, Frederiksberg Hospital, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Henning Bliddal, professor, Frederiksberg University Hospital Identifier: NCT00655941    
Other Study ID Numbers: H-B-2007-088
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012
Keywords provided by Henning Bliddal, Frederiksberg University Hospital:
Weight loss
Dietary instruction
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Weight Loss
Body Weight
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes