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Osteoarthritis, KneeCAROTNCT00655941

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

A study testing Dietary instruction and Exercise in people with Osteoarthritis, Knee and Obesity, run by Henning Bliddal at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis, Knee, Obesity
What is being tested?
Dietary instruction and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteDenmark
Study dates
Apr 2008to Jan 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • The Parker Institute, Frederiksberg Hospital

    Frederiksberg, Frederiksberg, 2000

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Dietary instruction, Exercise
Keywords
Osteoarthritis, Obesity, Weight loss, Dietary instruction, Exercise, Attention
Medical subject headings
Osteoarthritis, Knee, Obesity, Osteoarthritis, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary instructionBehavioural

    Also called The Cambridge Programme

    Weekly instruction by dieticians

  • ExerciseOther

    Supervised exercise in groups

Study groups in NCT00655941
Study groupRoleWhat they receive
1ExperimentalDietary instruction (low-energy diet. This is given by instructions in groups of 8
Receives: Behavioral: Dietary instruction
2Active comparatorExercise
Receives: Other: Exercise
3No interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

    Measured: 16 weeks, 68 weeks

  2. OMERACT-OARSI response criterion

    Measured: 16 weeks, 68 weeks

Secondary outcomes (7)

  1. Weight change

    Measured: 8 weeks, 16 weeks, 68 weeks

  2. Gait analysis

    Measured: 16 weeks, 68 weeks

  3. MRI

    Measured: 16 weeks, 68 weeks

  4. Ultrasound

    Measured: 16 weeks, 68 weeks

  5. Collagen markers

    Measured: 16 weeks, 68 weeks

  6. Metabolic syndrome

    Measured: 8 weeks, 16 weeks, 68 weeks

  7. KOOS

    Measured: 16 weeks, 68 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00655941
Sponsor's protocol ID
H-B-2007-088
Acronym
CAROT
Status last verified
Jan 2012
First submitted
4 Apr 2008
Last updated
6 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17204567

  • 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.

    PubMed 17038126

  • 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.

    PubMed 15639633

  • 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.

    PubMed 15769914

  • 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.

    PubMed 28689920

  • 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.

    PubMed 25370359

  • 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.

    PubMed 25106676

  • 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.

    PubMed 24636948

  • 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.

    PubMed 24135273

  • 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.

    PubMed 23522337

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

    PubMed 23484617

  • 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.

    PubMed 23274104

  • 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.

    PubMed 22190136

  • 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.

    PubMed 22161649

  • 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.

    PubMed 21851618

Questions about this trial

What is this clinical trial studying?

A study testing Dietary instruction and Exercise in people with Osteoarthritis, Knee and Obesity, run by Henning Bliddal at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: 16 weeks, 68 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655941, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.

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