The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening

• Conditions: Osteoarthritis, Knee
• Interventions: Other: level of physical activity

• Registration Number: NCT03358641
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Wuchuan Osteoarthritis Study is a population-based longitudinal study of natural history of knee osteoarthritis and its risk factors. At baseline and follow-up visits, IPA-Q questionnaire and a radiographs at tibiofemoral (TF) joints will be taken in order to assess the relationship between physical activity and radiographic osteoarthritis worsening.

Detailed Description

1025 residents aged ≥ 50 years will be recruited using door-to-door enumeration in randomly selected rural communities in Wuchuan, China, and will be followed in 3 years. At baseline and follow-up visits, subjects will complete a home interview (including, but not limited to, socio-demographic factors, physical activity level using IPA-Q questionnaire,WOMAC questionnaire) and have a weight-bearing posteroanterior semiflexed view of radiographs at tibiofemoral (TF) joints. Radiographic osteoarthritis (ROA) worsening for a knee is defined if its Kellgren and Lawrence (K/L) grade increases by at least 1 grade except for the change from 0 to 1 during follow-up. The relationship between level of physical activity and ROA worsening will be assessed.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-25
• Last Update Submitted: 2017-11-25
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. people aged 50 or over
2. Wuchuan permanent resident population

Exclusion Criteria

1. patients with rheumatoid arthritis
2. the disabled
3. patients with mental disorders
4. laid up for malignant tumor
5. people who live or work outside for more than half a year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wuchuan residents	level of physical activity	All residents that meet the criteria can be enrolled in this group, receiving a home interview (including IPA-Q to assess the level of physical activity) and a weight-bearing posteroanterior semiflexed view of radiographs at tibiofemoral (TF) joints at baseline and 3 years later.

Primary Outcome Measures

Name	Time	Method
worsening of radiographic osteoarthritis	3 years after enrollment	The tibiofemoral radiograph of both knee joint will be taken at baseline and in 3 years. Knee radiographs will be read by one investigator according to Kellgren and Lawrence (K/L) criteria. A knee will be defined as ROA worsening if its K/L grade increased by at least 1 grade except for the change from 0 to 1 during follow-up.

Secondary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Osteoarthritis Index	3 years after enrollment	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed at baseline and in 3 years, from which symptoms of patients can be estimated.