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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00655941
Acronym
CAROT
Enrollment
192
Registered
2008-04-10
Start date
2008-04-30
Completion date
2010-01-31
Last updated
2012-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoarthritis, Knee

Keywords

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

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.

Interventions

Weekly instruction by dieticians

OTHERExercise

Supervised exercise in groups

Sponsors

Velux Fonden
CollaboratorOTHER
Oak Foundation
CollaboratorOTHER
The Danish Rheumatism Association
CollaboratorOTHER
Cambridge Weight Plan Limited
CollaboratorINDUSTRY
Henning Bliddal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain16 weeks, 68 weeks
OMERACT-OARSI response criterion16 weeks, 68 weeks

Secondary

MeasureTime frame
MRI16 weeks, 68 weeks
Ultrasound16 weeks, 68 weeks
Weight change8 weeks, 16 weeks, 68 weeks
Metabolic syndrome8 weeks, 16 weeks, 68 weeks
KOOS16 weeks, 68 weeks
Collagen markers16 weeks, 68 weeks
Gait analysis16 weeks, 68 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026