- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00655941
Influence of Weight Loss or Exercise on Cartilage in Obese Knee Osteoarthritis Patients (CAROT)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Frederiksberg, Dinamarca, 2000
- The Parker Institute, Frederiksberg Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: 3
Ao controle
|
|
Comparador Ativo: 2
Exercício
|
Supervised exercise in groups
|
Experimental: 1
Dietary instruction (low-energy diet.
This is given by instructions in groups of 8
|
Weekly instruction by dieticians
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Pain
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
OMERACT-OARSI response criterion
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Weight change
Prazo: 8 weeks, 16 weeks, 68 weeks
|
8 weeks, 16 weeks, 68 weeks
|
Gait analysis
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
MRI
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
Ultrasound
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
Collagen markers
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
Metabolic syndrome
Prazo: 8 weeks, 16 weeks, 68 weeks
|
8 weeks, 16 weeks, 68 weeks
|
KOOS
Prazo: 16 weeks, 68 weeks
|
16 weeks, 68 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Henning Bliddal, Professor,MD, The Parker Institute, Frederiksberg Hospital, Denmark
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gudbergsen H. MRI in knee osteoarthritis. Application in diet intervention. Dan Med J. 2013 Mar;60(3):B4594.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-B-2007-088
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .