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

NCT00655941 | Completed

• 1 other identifier: H-B-2007-088
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Obesity

Keywords

Osteoarthritis; Obesity; Weight loss; Dietary instruction; Exercise; Attention

Outcome Measures

Primary Outcomes (2)

• Pain

  16 weeks, 68 weeks

• OMERACT-OARSI response criterion

  16 weeks, 68 weeks

Secondary Outcomes (7)

• Weight change

  8 weeks, 16 weeks, 68 weeks

• Gait analysis

  16 weeks, 68 weeks

• MRI

  16 weeks, 68 weeks

• Ultrasound

  16 weeks, 68 weeks

• Collagen markers

  16 weeks, 68 weeks

Study Arms (3)

1

EXPERIMENTAL

Dietary instruction (low-energy diet. This is given by instructions in groups of 8

Behavioral: Dietary instruction

2

ACTIVE COMPARATOR

Exercise

Other: Exercise

3

NO INTERVENTION

Control

Interventions

Dietary instruction BEHAVIORAL

Weekly instruction by dieticians

Also known as: The Cambridge Programme

1

Exercise OTHER

Supervised exercise in groups

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>=30
• Radiographical knee OA
• Age \>=50
• Spoken Danish
• Motivated for weight loss

You may not qualify if:

• Bilateral Alloplasty of the knees
• Ongoing or planned surgery
• Ongoing or planned alternative weight loss programme
• Intellectual disability

Sponsors & Collaborators

• Henning Bliddal: lead
• Velux Fonden: collaborator
• Oak Foundation: collaborator
• The Danish Rheumatism Association: collaborator
• Cambridge Weight Plan Limited: collaborator

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Frederiksberg, 2000, Denmark

Location

Related Publications (16)

• 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.

  PMID: 17204567 BACKGROUND

• 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.

  PMID: 17038126 BACKGROUND

• 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.

  PMID: 15639633 BACKGROUND

• 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.

  PMID: 15769914 BACKGROUND

• 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.

  PMID: 28689920 DERIVED

• 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.

  PMID: 25370359 DERIVED

• 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.

  PMID: 25106676 DERIVED

• 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.

  PMID: 24636948 DERIVED

• 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.

  PMID: 24135273 DERIVED

• 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.

  PMID: 23522337 DERIVED

• Gudbergsen H. MRI in knee osteoarthritis. Application in diet intervention. Dan Med J. 2013 Mar;60(3):B4594.

  PMID: 23484617 DERIVED

• 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.

  PMID: 23274104 DERIVED

• 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.

  PMID: 22190136 DERIVED

• 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.

  PMID: 22161649 DERIVED

• 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.

  PMID: 21851618 DERIVED

• 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.

  PMID: 20206314 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity; Osteoarthritis; Weight Loss; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Henning Bliddal, Professor,MD

  The Parker Institute, Frederiksberg Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

DK (1)