The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening

Osteoarthritis, Knee Clinical Trial

Official title:

The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening: Wuchuan Osteoarthritis Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03358641
• Other study ID #: PKUPHOSM
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 25, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Chutong Lin
• Phone: +86 15652930253
• Email: chutonglin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• level of physical activity
According to the result of IPA-Q questionnaire, participants are divided in three groups: low level, moderate level, high level of physical activity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	worsening of radiographic osteoarthritis	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.	3 years after enrollment
Secondary	The Western Ontario and McMaster Universities Osteoarthritis Index	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.	3 years after enrollment