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

Obesity Clinical Trial

— CAROT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655941
• Other study ID #: H-B-2007-088
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: January 5, 2012
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2012
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Weight Loss

Intervention

Behavioral:
• Dietary instruction
Weekly instruction by dieticians

Other:
• Exercise
Supervised exercise in groups

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg

Sponsors (5)

Lead Sponsor	Collaborator
Henning Bliddal	Cambridge Weight Plan Limited, Oak Foundation, The Danish Rheumatism Association, Velux Fonden

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Bliddal H, Christensen R. The management of osteoarthritis in the obese patient: practical considerations and guidelines for therapy. Obes Rev. 2006 Nov;7(4):323-31. Review. — View Citation

Christensen R, Astrup A, Bliddal H. Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. Osteoarthritis Cartilage. 2005 Jan;13(1):20-7. — View Citation

Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. Epub 2007 Jan 4. Review. — View Citation

Roddy E, Zhang W, Doherty M. Aerobic walking or strengthening exercise for osteoarthritis of the knee? A systematic review. Ann Rheum Dis. 2005 Apr;64(4):544-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		16 weeks, 68 weeks	No
Primary	OMERACT-OARSI response criterion		16 weeks, 68 weeks	No
Secondary	Weight change		8 weeks, 16 weeks, 68 weeks	No
Secondary	Gait analysis		16 weeks, 68 weeks	No
Secondary	MRI		16 weeks, 68 weeks	No
Secondary	Ultrasound		16 weeks, 68 weeks	No
Secondary	Collagen markers		16 weeks, 68 weeks	No
Secondary	Metabolic syndrome		8 weeks, 16 weeks, 68 weeks	No
Secondary	KOOS		16 weeks, 68 weeks	No