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

This study has been completed.
Sponsor:
Collaborators:
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Health & Weight Plan, UK
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00655941
First received: April 4, 2008
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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 Intervention
Osteoarthritis, Knee
Obesity
Behavioral: Dietary instruction
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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).

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • OMERACT-OARSI response criterion [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight change [ Time Frame: 8 weeks, 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • Gait analysis [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • MRI [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • Ultrasound [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • Collagen markers [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • Metabolic syndrome [ Time Frame: 8 weeks, 16 weeks, 68 weeks ] [ Designated as safety issue: No ]
  • KOOS [ Time Frame: 16 weeks, 68 weeks ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Exercise
Other: Exercise
Supervised exercise in groups
No Intervention: 3
Control

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655941

Locations
Denmark
The Parker Institute, Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Henning Bliddal
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Health & Weight Plan, UK
Investigators
Study Director: Henning Bliddal, Professor,MD The Parker Institute, Frederiksberg Hospital, Denmark
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Henning Bliddal, professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00655941     History of Changes
Other Study ID Numbers: H-B-2007-088
Study First Received: April 4, 2008
Last Updated: January 5, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Frederiksberg University Hospital:
Osteoarthritis
Obesity
Weight loss
Dietary instruction
Exercise
Attention

Additional relevant MeSH terms:
Obesity
Osteoarthritis
Weight Loss
Osteoarthritis, Knee
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes

ClinicalTrials.gov processed this record on July 20, 2014