The Halland Osteoarthritis Cohort
- Conditions
- Osteoarthritis, KneeOsteoarthritis HandOsteoarthritis Generalized
- Registration Number
- NCT04928170
- Lead Sponsor
- FoU Center Spenshult
- Brief Summary
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
- Detailed Description
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.
The cohort will be followed for five years with yearly follow-ups.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 312
Knee pain
Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HDL-cholesterol At 5 years follow-up HDL-cholesterol (mmol/L) meassured in serum
Leptin At 5 years follow-up Leptin (ng/mL) meassured in serum with ELISA
Maximal voluntary isometric contraction of Quadriceps At 5 years follow-up Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Pain intensity At 4 years follow-up Patient reported pain intensity by NRS scale 0-10 (best to worst)
Radiographic assessment of the knees At 5 years follow-up radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Total-cholesterol At 5 years follow-up Total-cholesterol (mmol/L) meassured in serum
LDL-cholesterol At 5 years follow-up LDL-cholesterol (mmol/L) meassured in serum
Interleukin-1 (IL-1) At 5 years follow-up IL-1 (pg/mL) meassured in plasma with ELISA
Galectin-1 At 5 years follow-up Galectin-1 (ng/mL) meassured in plasma with ELISA
One-leg rise At 5 years follow-up Knee strenght are assessed by one-leg rise
Hand strenght At 5 years follow-up Hand strenght are assessed by grippit (N)
BMI (kg/m2) At 5 years follow-up weight (kg) and height (m) are meassured and BMI will be calculated
Abdominal circumference (cm) At 5 years follow-up Abdominal circumference are meassured with measuring tape at navel height
HbA1c At 5 years follow-up HbA1c (mmol/mol) meassured in serum
Triglycerides At 5 years follow-up Triglycerides (mmol/L) meassured in serum
Body composition 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 At 5 years follow-up Fasting glucos (mmol/L) meassured in serum
Tumor Necrosis Factor-alfa (TNF-alfa) At 5 years follow-up TNF-alfa (pg/mL) meassured in plasma with ELISA
Fitness At 5 years follow-up Fitness are assessed by Åstrands test
Pain mannequin At 5 years follow-up Patient reported pain distribution
Sensitive C-Reactive Protein (CRP) At 5 years follow-up sensitive CRP (g/L) meassured in serum
Pain thresholds 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 At 5 years follow-up Radiographic assessment of the hands.
Mechanical load At 5 years follow-up Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Interleukin-6 (IL-6) At 5 years follow-up IL-6 (pg/mL) meassured in plasma with ELISA
30s-chair stand test At 5 years follow-up Knee strenght are assessed by 30s-chair stand test
Knee injury and osteoarthritis outcome score (KOOS) 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 At 5 years follow-up Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Secondary Outcome Measures
Name Time Method Patient reported smoking and snuff habits At 5 years follow-up Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Hospital Anxiety and Depression Scale (HADS) At 5 years follow-up HADS is a simple self-assessment form that shows a measure of the patient's mood.
Blood pressure At 5 years follow-up Blood pressure assessed in sitting position after rest, mmHg
Blood samples for biobanking At 5 years follow-up serum and plasma for biobanking in -70 degrees celcius
Patient reported physical activity At 5 years follow-up Patient reported physical activity with questions duration and intensity according to WHO recommendations
Patient reported alcohol habits At 5 years follow-up Patient reported alcohol habis assessed by AUDIT C
Clinical examination of the knees At 5 years follow-up Clinical examination to assessing clinical knee OA
Patient reported diets At 5 years follow-up Patient reported diets and intake of fruits and sweets
Clinical examination of the hands At 5 years follow-up Clinical examination of the hands assessing clinical hand OA
Health literacy At 5 years follow-up Health literacy assessed with the Swedish Functional Health Literacy scale
Trial Locations
- Locations (1)
Spenshult Research and Development center (FoU Spenshult)
🇸🇪Halmstad, Sweden