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Completed

NCT Number: NCT00655941

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary instruction

Behavioral

Weekly instruction by dieticians

Other names: The Cambridge Programme

Exercise

Other

Supervised exercise in groups

Primary outcomes

  1. Pain

    Time frame: 16 weeks, 68 weeks

  2. OMERACT-OARSI response criterion

    Time frame: 16 weeks, 68 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Henning Bliddal

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CAROT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 10, 2008
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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