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

Primary Purpose

Osteoarthritis, Knee, Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary instruction
Exercise
Sponsored by
Henning Bliddal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Obesity, Weight loss, Dietary instruction, Exercise, Attention

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Parker Institute, Frederiksberg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

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

Exercise

Control

Outcomes

Primary Outcome Measures

Pain
OMERACT-OARSI response criterion

Secondary Outcome Measures

Weight change
Gait analysis
MRI
Ultrasound
Collagen markers
Metabolic syndrome
KOOS

Full Information

First Posted
April 4, 2008
Last Updated
January 5, 2012
Sponsor
Henning Bliddal
Collaborators
Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00655941
Brief Title
Influence of Weight Loss or Exercise on Cartilage in Obese Knee Osteoarthritis Patients
Acronym
CAROT
Official Title
Influence of Weight Loss or Exercise on CARtilage in Obese Knee Osteoarthritis Patients: a Randomized Controlled Trial (CAROT).
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Bliddal
Collaborators
Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Obesity
Keywords
Osteoarthritis, Obesity, Weight loss, Dietary instruction, Exercise, Attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dietary instruction (low-energy diet. This is given by instructions in groups of 8
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exercise
Arm Title
3
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Dietary instruction
Other Intervention Name(s)
The Cambridge Programme
Intervention Description
Weekly instruction by dieticians
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Supervised exercise in groups
Primary Outcome Measure Information:
Title
Pain
Time Frame
16 weeks, 68 weeks
Title
OMERACT-OARSI response criterion
Time Frame
16 weeks, 68 weeks
Secondary Outcome Measure Information:
Title
Weight change
Time Frame
8 weeks, 16 weeks, 68 weeks
Title
Gait analysis
Time Frame
16 weeks, 68 weeks
Title
MRI
Time Frame
16 weeks, 68 weeks
Title
Ultrasound
Time Frame
16 weeks, 68 weeks
Title
Collagen markers
Time Frame
16 weeks, 68 weeks
Title
Metabolic syndrome
Time Frame
8 weeks, 16 weeks, 68 weeks
Title
KOOS
Time Frame
16 weeks, 68 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bliddal, Professor,MD
Organizational Affiliation
The Parker Institute, Frederiksberg Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
17204567
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.
Results Reference
background
PubMed Identifier
17038126
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.
Results Reference
background
PubMed Identifier
15639633
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.
Results Reference
background
PubMed Identifier
15769914
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.
Results Reference
background
PubMed Identifier
28689920
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.
Results Reference
derived
PubMed Identifier
25370359
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.
Results Reference
derived
PubMed Identifier
25106676
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.
Results Reference
derived
PubMed Identifier
24636948
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.
Results Reference
derived
PubMed Identifier
24135273
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.
Results Reference
derived
PubMed Identifier
23522337
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.
Results Reference
derived
PubMed Identifier
23484617
Citation
Gudbergsen H. MRI in knee osteoarthritis. Application in diet intervention. Dan Med J. 2013 Mar;60(3):B4594.
Results Reference
derived
PubMed Identifier
23274104
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.
Results Reference
derived
PubMed Identifier
22190136
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.
Results Reference
derived
PubMed Identifier
22161649
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.
Results Reference
derived
PubMed Identifier
21851618
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.
Results Reference
derived
PubMed Identifier
20206314
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.
Results Reference
derived

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

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