Lifestyle intervention trial in early stage knee osteoarthritis

The cost-effectiveness and effectiveness of a combined lifestyle intervention in overweight and obese patients with early stage knee osteoarthritis in primary care.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24915

Enrollment

234

Registered

2021-03-23

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Knee osteoarthritis

Interventions

Multidisciplinary lifestyle interventions with a focus on diet and exercise show large potential for the treatment of knee OA. The 2-year lifestyle intervention (Beweegkuur-GLI) program is based on th

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 45 and 70 years, a BMI of 25 kg/m2 or higher, diagnosis of clinical knee OA (according to NICE guidelines), and a first presentation at their general practitioner with knee complaints within the previous 24 months will be included.

Exclusion criteria

Exclusion criteria: - Other pathological conditions that could explain the joint complaints like traumatic onset knee complaints or presence of other forms of arthritis (rheumatoid arthritis, psoriatic arthritis), pre-patellar bursitis or patellar tendinitis; - Any lower extremity condition other than KOA resulting in physical impairment that will limit GLI participation. - Previously participated in a combined lifestyle intervention (GLI); - Contraindications for MRI; - Not being able to speak, read or write Dutch.

Design outcomes

Primary

Measure	Time frame
The primary outcomes include a 5 kg or 5% weight reduction at 24 months follow-up, clinical progression (mean pain intensity during the last month (11-point NRS) over 24 months of follow-up), structural progression on MRI at 24 months follow-up (MOAKS: change of individual MOAKS features per subregion and summed change per MOAKS features), and health-related quality of life measured with the EQ-5D-5L over 24 months. For the cost-effectiveness analysis, societal costs over 24 months using the medical consumption and productivity cost questionnaire (iMCQ and iPCQ) will be evaluated.	—

Measure

Time frame

The primary outcomes include a 5 kg or 5% weight reduction at 24 months follow-up, clinical progression (mean pain intensity during the last month (11-point NRS) over 24 months of follow-up), structural progression on MRI at 24 months follow-up (MOAKS: change of individual MOAKS features per subregion and summed change per MOAKS features), and health-related quality of life measured with the EQ-5D-5L over 24 months. For the cost-effectiveness analysis, societal costs over 24 months using the medical consumption and productivity cost questionnaire (iMCQ and iPCQ) will be evaluated.

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Secondary

Measure	Time frame
Patients’ reported severity of knee pain and activity limitations evaluated over 24 months with the Knee injury and Osteoarthritis Outcome Score (KOOS); the severity of intermittent and constant osteoarthritis pain (ICOAP); the global rating of change (GRoC); Patient Acceptable Symptom State (PASS); and mean pain intensity during the last month (11-point NRS) over the last 12 months of follow-up. Moreover, general health outcomes including blood pressure, HbA1c levels, and cholesterol are evaluated at 24 month follow-up.	—

Measure

Time frame

Patients’ reported severity of knee pain and activity limitations evaluated over 24 months with the Knee injury and Osteoarthritis Outcome Score (KOOS); the severity of intermittent and constant osteoarthritis pain (ICOAP); the global rating of change (GRoC); Patient Acceptable Symptom State (PASS); and mean pain intensity during the last month (11-point NRS) over the last 12 months of follow-up. Moreover, general health outcomes including blood pressure, HbA1c levels, and cholesterol are evaluated at 24 month follow-up.

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Contacts

Public ContactMarienke van Middelkoop

Erasmuc MC, dept. General Practice

m.vanmiddelkoop@erasmusmc.nl010 703 2114

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)