Clinical trial NCT00655941: Influence of Weight Loss or Exercise on Cartilage in Obese Knee Osteoarthritis Patients
Official title: Influence of Weight Loss or Exercise on CARtilage in Obese Knee Osteoarthritis Patients: a Randomized Controlled Trial (CAROT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Obesity
Keywords: Osteoarthritis
Obesity
Weight loss
Dietary instruction
Exercise
Attention
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Oak Foundation
name: The Danish Rheumatism Association
name: Cambridge Weight Plan Limited
First posted: 2008-04-10
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Pain
timeFrame: 16 weeks, 68 weeks
measure: OMERACT-OARSI response criterion
timeFrame: 16 weeks, 68 weeks
Secondary outcomes:
measure: Weight change
timeFrame: 8 weeks, 16 weeks, 68 weeks
measure: Gait analysis
timeFrame: 16 weeks, 68 weeks
measure: MRI
timeFrame: 16 weeks, 68 weeks
measure: Ultrasound
timeFrame: 16 weeks, 68 weeks
measure: Collagen markers
timeFrame: 16 weeks, 68 weeks
measure: Metabolic syndrome
timeFrame: 8 weeks, 16 weeks, 68 weeks
measure: KOOS
timeFrame: 16 weeks, 68 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The Parker Institute, Frederiksberg Hospital, Denmark
name: Henning Bliddal, Professor,MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
citation: 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. doi: 10.1111/j.1467-789X.2006.00252.x.
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. doi: 10.1016/j.joca.2004.10.008.
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. doi: 10.1136/ard.2004.028746.
citation: Bartels EM, Henrotin Y, Bliddal H, Centonze P, Henriksen M. Relationship between weight loss in obese knee osteoarthritis patients and serum biomarkers of cartilage breakdown: secondary analyses of a randomised trial. Osteoarthritis Cartilage. 2017 Oct;25(10):1641-1646. doi: 10.1016/j.joca.2017.06.009. Epub 2017 Jul 6.
citation: Christensen R, Henriksen M, Leeds AR, Gudbergsen H, Christensen P, Sorensen TJ, Bartels EM, Riecke BF, Aaboe J, Frederiksen R, Boesen M, Lohmander LS, Astrup A, Bliddal H. Effect of weight maintenance on symptoms of knee osteoarthritis in obese patients: a twelve-month randomized controlled trial. Arthritis Care Res (Hoboken). 2015 May;67(5):640-50. doi: 10.1002/acr.22504.
citation: Bartels EM, Christensen R, Christensen P, Henriksen M, Bennett A, Gudbergsen H, Boesen M, Bliddal H. Effect of a 16 weeks weight loss program on osteoarthritis biomarkers in obese patients with knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2014 Nov;22(11):1817-25. doi: 10.1016/j.joca.2014.07.027. Epub 2014 Aug 12.
citation: Henriksen M, Christensen R, Hunter DJ, Gudbergsen H, Boesen M, Lohmander LS, Bliddal H. Structural changes in the knee during weight loss maintenance after a significant weight loss in obese patients with osteoarthritis: a report of secondary outcome analyses from a randomized controlled trial. Osteoarthritis Cartilage. 2014 May;22(5):639-46. doi: 10.1016/j.joca.2014.03.003. Epub 2014 Mar 15.
citation: Henriksen M, Hunter DJ, Dam EB, Messier SP, Andriacchi TP, Lohmander LS, Aaboe J, Boesen M, Gudbergsen H, Bliddal H, Christensen R. Is increased joint loading detrimental to obese patients with knee osteoarthritis? A secondary data analysis from a randomized trial. Osteoarthritis Cartilage. 2013 Dec;21(12):1865-75. doi: 10.1016/j.joca.2013.10.003. Epub 2013 Oct 14.
citation: Gudbergsen H, Boesen M, Christensen R, Bartels EM, Henriksen M, Danneskiold-Samsoe B, Bliddal H. Changes in bone marrow lesions in response to weight-loss in obese knee osteoarthritis patients: a prospective cohort study. BMC Musculoskelet Disord. 2013 Mar 22;14:106. doi: 10.1186/1471-2474-14-106.
citation: Gudbergsen H. MRI in knee osteoarthritis. Application in diet intervention. Dan Med J. 2013 Mar;60(3):B4594.
citation: Gudbergsen H, Lohmander LS, Jones G, Christensen R, Bartels EM, Danneskiold-Samsoe B, Bliddal H, Boesen M. Correlations between radiographic assessments and MRI features of knee osteoarthritis--a cross-sectional study. Osteoarthritis Cartilage. 2013 Apr;21(4):535-43. doi: 10.1016/j.joca.2012.12.010. Epub 2012 Dec 26.
citation: Christensen P, Bartels EM, Riecke BF, Bliddal H, Leeds AR, Astrup A, Winther K, Christensen R. Improved nutritional status and bone health after diet-induced weight loss in sedentary osteoarthritis patients: a prospective cohort study. Eur J Clin Nutr. 2012 Apr;66(4):504-9. doi: 10.1038/ejcn.2011.201. Epub 2011 Dec 21.
citation: Henriksen M, Christensen R, Danneskiold-Samsoe B, Bliddal H. Changes in lower extremity muscle mass and muscle strength after weight loss in obese patients with knee osteoarthritis: a prospective cohort study. Arthritis Rheum. 2012 Feb;64(2):438-42. doi: 10.1002/art.33394.
citation: Gudbergsen H, Bartels EM, Krusager P, Waehrens EE, Christensen R, Danneskiold-Samsoe B, Bliddal H. Test-retest of computerized health status questionnaires frequently used in the monitoring of knee osteoarthritis: a randomized crossover trial. BMC Musculoskelet Disord. 2011 Aug 18;12:190. doi: 10.1186/1471-2474-12-190.
citation: Riecke BF, Christensen R, Christensen P, Leeds AR, Boesen M, Lohmander LS, Astrup A, Bliddal H. Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial. Osteoarthritis Cartilage. 2010 Jun;18(6):746-54. doi: 10.1016/j.joca.2010.02.012. Epub 2010 Feb 17.