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

January 5, 2012 updated by: Henning Bliddal

Influence of Weight Loss or Exercise on CARtilage in Obese Knee Osteoarthritis Patients: a Randomized Controlled Trial (CAROT).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 3
Control
Active Comparator: 2
Exercise
Other: Exercise
Supervised exercise in groups
Experimental: 1
Dietary instruction (low-energy diet. This is given by instructions in groups of 8
Behavioral: Dietary instruction
Weekly instruction by dieticians
Other Names:
  • The Cambridge Programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks
OMERACT-OARSI response criterion
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: 8 weeks, 16 weeks, 68 weeks
8 weeks, 16 weeks, 68 weeks
Gait analysis
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks
MRI
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks
Ultrasound
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks
Collagen markers
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks
Metabolic syndrome
Time Frame: 8 weeks, 16 weeks, 68 weeks
8 weeks, 16 weeks, 68 weeks
KOOS
Time Frame: 16 weeks, 68 weeks
16 weeks, 68 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henning Bliddal

Collaborators

Cambridge Weight Plan Limited
Velux Fonden
Oak Foundation
The Danish Rheumatism Association

Investigators

  • Study Director: Henning Bliddal, Professor,MD, The Parker Institute, Frederiksberg Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-B-2007-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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