Osteoarthritis, KneeNCT03358641
The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening
An observational study of Osteoarthritis, Knee, run by Peking University People's Hospital.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- level of physical activity
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: People, over 50 years old, in a rural area in Northern China (Wuchuan, Inner Mongolia)
Who may be able to join
- people aged 50 or over
- Wuchuan permanent resident population
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- level of physical activity
- Keywords
- exercise, physical activity, radiographic osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of physical activityOther
According to the result of IPA-Q questionnaire, participants are divided in three groups: low level, moderate level, high level of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: level of physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after enrollment
Secondary outcomes (1)
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.
Measured: 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chutong, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, arthritis clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358641
- Sponsor's protocol ID
- PKUPHOSM
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening: Wuchuan Osteoarthritis Study
- ClinicalTrials.gov ID
- NCT03358641
- Acronym / sponsor ID
- PKUPHOSM
- Conditions
- Osteoarthritis, Knee
- Keywords
- exercise, physical activity, radiographic osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wuchuan residents | – | Other: level of physical activityAll 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People, over 50 years old, in a rural area in Northern China (Wuchuan, Inner Mongolia)
Key inclusion criteria (2 listed)
- people aged 50 or over
- Wuchuan permanent resident population
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| level of physical activityAccording to the result of IPA-Q questionnaire, participants are divided in three groups: low level, moderate level, high level of physical activity. | Other | Wuchuan residents |
Primary outcome
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.
1 secondary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 3 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhao Lin, MD principal investigator
arthritis clinic and research center
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chutong Lin (+86 15652930253, chutonglin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
worsening of radiographic osteoarthritis (time frame: 3 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.