NCT03358641

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

November 25, 2017

Last Update Submit

November 25, 2017

Conditions

Keywords

exercisephysical activityradiographic osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Western Ontario and McMaster Universities Osteoarthritis Index

    3 years after enrollment

Study Arms (1)

Wuchuan residents

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.

Other: level of physical activity

Interventions

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

Wuchuan residents

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People, over 50 years old, in a rural area in Northern China (Wuchuan, Inner Mongolia)

You may qualify if:

  • people aged 50 or over
  • Wuchuan permanent resident population

You may not qualify if:

  • patients with rheumatoid arthritis
  • the disabled
  • patients with mental disorders
  • laid up for malignant tumor
  • people who live or work outside for more than half a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Jianhao Lin, MD

    arthritis clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
arthritis clinic and research center

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share