The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening

November 25, 2017 updated by: Lin Chutong, Peking University People's Hospital

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
worsening of radiographic osteoarthritis
Time Frame: 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.
3 years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 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.
3 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jianhao Lin, MD, arthritis clinic and research center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 25, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 25, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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