The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- BMI (kg/m2)
研究概览
简要总结
Osteoarthritis is the most common musculoskeletal disease and is characterized by cartilage destruction, osteophyte formation, subchondral bone sclerosis and cysts. Modern treatment strategies, as well as preventive measures, include early detection and knowledge of the early course of the disease. This includes how stress patterns, physical activity, impaired function and metabolic changes and other comorbidities affect development and possible associations with osteoarthritis.
The overall objective was to study the early development of osteoarthritis of the knee and its association with hand- and general osteoarthritis, metabolic diseases, biomarkers, long-term pain, physical function and stress patterns
详细描述
The overall objective was to study the early development of osteoarthritis of the knee and its association with hand- and general osteoarthritis, metabolic diseases, biomarkers, long-term pain, physical function and stress patterns.
The project includes 4 different research areas that are studied with the help of several smaller sub-studies:
Research area 1: Metabolic osteoarthritis - to study the connections between metabolic factors and osteoarthritis development in the knee and hand.
A. Relationship between knee osteoarthritis and metabolic factors B. Relationship between osteoarthritis of the hand and metabolic factors Research area 2: Biomarkers in knee and hand osteoarthritis - to study cartilage and bone markers that reflect different processes in osteoarthritis development, e.g. inflammation, matrix degradation both in the short and long term Research area 3: Pain and osteoarthritis - to study pain development and pain pressure thresholds in relation to lifestyle, depression and health-related quality of life in individuals with symptomatic knee osteoarthritis Research area 4: Physical function and osteoarthritis - to study physical function, physical activity and measured stress patterns, as well as changes in stress patterns and the relationship between these and the development of osteoarthritis over time.
Study design This is a longitudinal cohort study including 306 individuals with knee pain in the southwest of Sweden, the Halland osteoarthritis (HALLOA) cohort. The enrolments took place from 2017-2019. The participants were recruited: 1) by primary health care clinics when searching care for knee pain, or 2) by advertisements in local newspapers. The inclusion criterions were current knee pain, aged 30-65 years, with no former known radiographic knee osteoarthritis (RKOA). the exclusion criterions were no cruciate ligament rupture or rheumatologic disorder. A general practitioner examined all participants to confirm the exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
结局指标
主要结局
BMI (kg/m2)
时间窗: At 5 years follow-up
weight (kg) and height (m) are meassured and BMI will be calculated
Abdominal circumference (cm)
时间窗: At 5 years follow-up
Abdominal circumference are meassured with measuring tape at navel height
HbA1c
时间窗: At 5 years follow-up
HbA1c (mmol/mol) meassured in serum
Body composition
时间窗: At 5 years follow-up
Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat
Glucos
时间窗: At 5 years follow-up
Fasting glucos (mmol/L) meassured in serum
Triglycerides
时间窗: At 5 years follow-up
Triglycerides (mmol/L) meassured in serum
HDL-cholesterol
时间窗: At 5 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Leptin
时间窗: At 5 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Maximal voluntary isometric contraction of Quadriceps
时间窗: At 5 years follow-up
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Pain intensity
时间窗: At 4 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Radiographic assessment of the knees
时间窗: At 5 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Tumor Necrosis Factor-alfa (TNF-alfa)
时间窗: At 5 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Fitness
时间窗: At 5 years follow-up
Fitness are assessed by Åstrands test
Pain mannequin
时间窗: At 5 years follow-up
Patient reported pain distribution
Total-cholesterol
时间窗: At 5 years follow-up
Total-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
时间窗: At 5 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
Interleukin-1 (IL-1)
时间窗: At 5 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Galectin-1
时间窗: At 5 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
One-leg rise
时间窗: At 5 years follow-up
Knee strenght are assessed by one-leg rise
Hand strenght
时间窗: At 5 years follow-up
Hand strenght are assessed by grippit (N)
Sensitive C-Reactive Protein (CRP)
时间窗: At 5 years follow-up
sensitive CRP (g/L) meassured in serum
Pain thresholds
时间窗: At 5 years follow-up
pain threshold are assesed by computerized pressure algometry on eight predefined tender points out of the 18 points as part of the definition of fibromyalgia
Radiographic assessment of the hands
时间窗: At 5 years follow-up
Radiographic assessment of the hands.
Mechanical load
时间窗: At 5 years follow-up
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Interleukin-6 (IL-6)
时间窗: At 5 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
30s-chair stand test
时间窗: At 5 years follow-up
Knee strenght are assessed by 30s-chair stand test
Knee injury and osteoarthritis outcome score (KOOS)
时间窗: At 5 years follow-up
KOOS consists of 5 subscales, assessing knee pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
Patient intensity
时间窗: At 5 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
次要结局
- Blood samples for biobanking(At 5 years follow-up)
- Patient reported physical activity(At 5 years follow-up)
- Patient reported alcohol habits(At 5 years follow-up)
- Clinical examination of the knees(At 5 years follow-up)
- Health literacy(At 5 years follow-up)
- Patient reported diets(At 5 years follow-up)
- Clinical examination of the hands(At 5 years follow-up)
- Patient reported smoking and snuff habits(At 5 years follow-up)
- Hospital Anxiety and Depression Scale (HADS)(At 5 years follow-up)
- Blood pressure(At 5 years follow-up)