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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee; Obesity
• Interventions: Other: Exercise; Behavioral: Dietary instruction

• Registration Number: NCT00655941
• Lead Sponsor: Henning Bliddal

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Exercise	Exercise
1	Dietary instruction	Dietary instruction (low-energy diet. This is given by instructions in groups of 8

Primary Outcome Measures

Name	Time	Method
Pain	16 weeks, 68 weeks
OMERACT-OARSI response criterion	16 weeks, 68 weeks

Secondary Outcome Measures

Name	Time	Method
MRI	16 weeks, 68 weeks
Ultrasound	16 weeks, 68 weeks
Collagen markers	16 weeks, 68 weeks
Metabolic syndrome	8 weeks, 16 weeks, 68 weeks
KOOS	16 weeks, 68 weeks
Gait analysis	16 weeks, 68 weeks
Weight change	8 weeks, 16 weeks, 68 weeks

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark