Clinical trial NCT04033757: A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study
Official title: A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Keywords: osteoarthritis
cohort study
population-based
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Harvard University
First posted: 2019-07-26
Enrollment: 4080
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older, from rural mountainous communities of Longshan County, Hunan Province, China.

Brief summary: The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.

Detailed description: Objectives:

1. To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
2. To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
3. To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
4. To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
5. To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
6. To investigate the association between gut microbiota and OA.
7. To investigate the association between oral microbiota and OA.

Design: This is a prospective community-based cohort study.

Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.

Eligibility criteria: Inclusion Criteria:

1. 50 years old or above
2. Residents of the randomly selected communities

Exclusion Criteria:

1. Inability to give informed consent
2. Terminal or mental illness
3. Pregnant women

Primary outcomes:
measure: Prevalence of multiple joints osteoarthritis.
timeFrame: At enrollment.
measure: Incidence of multiple joints osteoarthritis.
timeFrame: At 3, 6, 9, 12 years follow-ups after enrollment.
measure: Progression of multiple joints osteoarthritis.
timeFrame: At 3, 6, 9, 12 years follow-ups after enrollment.
Secondary outcomes:
measure: Ultrasound detected changes of knee, thigh muscle, and hand.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of pain intensity of knee, hip, hand and lumbar.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of pain experience of knee.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of neuropathic pain of knee.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of patient's belief about knee pain.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of pain catastrophizing of knee.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Prevalence of knee/hip/patellofemoral joint pain.
timeFrame: At enrollment.
measure: Incidence of knee/hip/patellofemoral joint pain.
timeFrame: At 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of global assessment of knee and hip.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of global hand function.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of pain-related disability of lumbar osteoarthritis.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of 30s repetition chair stand test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of 20-meter walk test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of timed up and go test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of standing balance test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of grip strength.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of pinch strength.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of quadriceps strength.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of hamstrings strength.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of hip abductor.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of squatting ability test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of stair climbing test.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of quantitative sensory testing.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of the results of body composition analysis.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Prevalence of nodal osteoarthritis.
timeFrame: At enrollment.
measure: Prevalence of widespread pain.
timeFrame: At enrollment.
measure: Incidence of widespread pain.
timeFrame: At 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of physical and mental health.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Changes of sleep quality.
timeFrame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
measure: Prevalence of sarcopenia.
timeFrame: Every round of surveys since year 2018.
measure: Incidence of sarcopenia.
timeFrame: At 3, 6, 9, 12 years follow-ups after enrollment.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Guanghua Lei, Doctor
role: STUDY_CHAIR
References: