The Halland Osteoarthritis Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis

Conditions
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Osteoarthritis, Knee, Osteoarthritis Hand, Osteoarthritis Generalized

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee pain Exclusion Criteria: Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HALLOA<br>306 individuals with knee pain in the age between 30 and 65 years, without cruciate ligament injury | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (kg/m2) | weight (kg) and height (m) are meassured and BMI will be calculated | At baseline | 
| BMI (kg/m2) | weight (kg) and height (m) are meassured and BMI will be calculated | At 2 years follow-up | 
| BMI (kg/m2) | weight (kg) and height (m) are meassured and BMI will be calculated | At 5 years follow-up | 
| Abdominal circumference (cm) | Abdominal circumference are meassured with measuring tape at navel height | At baseline | 
| Abdominal circumference (cm) | Abdominal circumference are meassured with measuring tape at navel height | At 2 years follow-up | 
| Abdominal circumference (cm) | Abdominal circumference are meassured with measuring tape at navel height | At 5 years follow-up | 
| Body composition | Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat | At baseline | 
| Body composition | Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat | At 2 years follow-up | 
| Body composition | Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat | At 5 years follow-up | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At Baseline | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At 1 year follow-up | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At 2 years follow-up | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At 3 years follow-up | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At 4 years follow-up | 
| Glucos | Fasting glucos (mmol/L) meassured in serum | At 5 years follow-up | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At baseline | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At 1 year follow-up | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At 2 years follow-up | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At 3 years follow-up | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At 4 years follow-up | 
| HbA1c | HbA1c (mmol/mol) meassured in serum | At 5 years follow-up | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At baseline | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At 1 year follow-up | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At 2 years follow-up | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At 3 years follow-up | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At 4 years follow-up | 
| Total-cholesterol | Total-cholesterol (mmol/L) meassured in serum | At 5 years follow-up | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At baseline | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At 1 year follow-up | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At 2 years follow-up | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At 3 years follow-up | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At 4 years follow-up | 
| Triglycerides | Triglycerides (mmol/L) meassured in serum | At 5 years follow-up | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At baseline | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At 1 year follow-up | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At 2 years follow-up | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At 3 years follow-up | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At 4 years follow-up | 
| LDL-cholesterol | LDL-cholesterol (mmol/L) meassured in serum | At 5 years follow-up | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At baseline | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At 1 year follow-up | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At 2 years follow-up | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At 3 years follow-up | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At 4 years follow-up | 
| HDL-cholesterol | HDL-cholesterol (mmol/L) meassured in serum | At 5 years follow-up | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At baseline | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At 1 year follow-up | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At 2 years follow-up | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At 3 years follow-up | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At 4 years follow-up | 
| Sensitive C-Reactive Protein (CRP) | sensitive CRP (g/L) meassured in serum | At 5 years follow-up | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At baseline | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At 1 year follow-up | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At 2 years follow-up | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At 3 years follow-up | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At 4 years follow-up | 
| Interleukin-1 (IL-1) | IL-1 (pg/mL) meassured in plasma with ELISA | At 5 years follow-up | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At baseline | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At 1 year follow-up | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At 2 years follow-up | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At 3 years follow-up | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At 4 years follow-up | 
| Interleukin-6 (IL-6) | IL-6 (pg/mL) meassured in plasma with ELISA | At 5 years follow-up | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At baseline | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At 1 year follow-up | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At 2 years follow-up | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At 3 years folllow-up | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At 4 years follow-up | 
| Tumor Necrosis Factor-alfa (TNF-alfa) | TNF-alfa (pg/mL) meassured in plasma with ELISA | At 5 years follow-up | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At baseline | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At 1 year follow-up | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At 2 years follow-up | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At 3 years follow-up | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At 4 years follow-up | 
| Leptin | Leptin (ng/mL) meassured in serum with ELISA | At 5 years follow-up | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At baseline | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At 1 year follow-up | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At 2 years follow-up | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At 3 years follow-up | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At 4 years follow-up | 
| Galectin-1 | Galectin-1 (ng/mL) meassured in plasma with ELISA | At 5 years follow-up | 
| One-leg rise | Knee strenght are assessed by one-leg rise | At baseline | 
| One-leg rise | Knee strenght are assessed by one-leg rise | At 2 years follow-up | 
| One-leg rise | Knee strenght are assessed by one-leg rise | At 5 years follow-up | 
| 30s-chair stand test | Knee strenght are assessed by 30s-chair stand test | At baseline | 
| 30s-chair stand test | Knee strenght are assessed by 30s-chair stand test | At 2 years follow-up | 
| 30s-chair stand test | Knee strenght are assessed by 30s-chair stand test | At 5 years follow-up | 
| Maximal voluntary isometric contraction of Quadriceps | Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) | At baseline | 
| Maximal voluntary isometric contraction of Quadriceps | Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) | At 2 years follow-up | 
| Maximal voluntary isometric contraction of Quadriceps | Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) | At 5 years follow-up | 
| Hand strenght | Hand strenght are assessed by grippit (N) | At baseline | 
| Hand strenght | Hand strenght are assessed by grippit (N) | At 2 years follow-up | 
| Hand strenght | Hand strenght are assessed by grippit (N) | At 5 years follow-up | 
| Fitness | Fitness are assessed by Åstrands test | At 2 years follow-up | 
| Fitness | Fitness are assessed by Åstrands test | At 5 years follow-up | 
| Pain thresholds | 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 | At baseline | 
| Pain thresholds | 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 | At 2 years follow-up | 
| Pain thresholds | 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 | At 5 years follow-up | 
| Knee injury and osteoarthritis outcome score (KOOS) | KOOS consists of 5 subscales, assessing self reported knee pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). | At baseline | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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). | At 1 year follow-up | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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). | At 2 years follow-up | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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). | At 3 years follow-up | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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). | At 4 years follow-up | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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). | At 5 years follow-up | 
| Pain mannequin | Patient reported pain distribution | At baseline | 
| Pain mannequin | Patient reported pain distribution | At 1 year follow-up | 
| Pain mannequin | Patient reported pain distribution | At 2 years follow-up | 
| Pain mannequin | Patient reported pain distribution | At 3 years follow-up | 
| Pain mannequin | Patient reported pain distribution | At 4 years follow-up | 
| Pain mannequin | Patient reported pain distribution | At 5 years follow-up | 
| Pain intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At baseline | 
| Pain intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At 1 year follow-up | 
| Pain intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At 2 years follow-up | 
| Pain intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At 3 years follow-up | 
| Pain intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At 4 years follow-up | 
| Patient intensity | Patient reported pain intensity by NRS scale 0-10 (best to worst) | At 5 years follow-up | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At baseline | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At 1 year follow-up | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At 2 years follow-up | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At 3 years follow-up | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At 4 years follow-up | 
| Radiographic assessment of the knees | radiographic assessment of tibiofemoral- and patellofemoral joint in the knee | At 5 years follow-up | 
| Radiographic assessment of the hands | Radiographic assessment of the hands. | At 2 years follow-up | 
| Radiographic assessment of the hands | Radiographic assessment of the hands. | At 5 years follow-up | 
| Mechanical load | Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days | At inclusion | 
| Mechanical load | Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days | At 2 years follow-up | 
| Mechanical load | Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days | At 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At baseline | 
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At 1 year follow-up | 
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At 2 years follow-up | 
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At 3 years follow-up | 
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At 4 years follow-up | 
| Blood samples for biobanking | serum and plasma for biobanking in -70 degrees celcius | At 5 years follow-up | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At baseline | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At 1 year follow-up | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At 2 years follow-up | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At 3 years follow-up | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At 4 years follow-up | 
| Patient reported physical activity | Patient reported physical activity with questions duration and intensity according to WHO recommendations | At 5 years follow-up | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At baseline | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At 1 years follow-up | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At 2 years follow-up | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At 3 years follow-up | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At 4 years follow-up | 
| Patient reported smoking and snuff habits | Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff | At 5 years follow-up | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At baseline | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At 1 year follow-up | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At 2 years follow-up | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At 3 years follow-up | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At 4 years follow-up | 
| Patient reported diets | Patient reported diets and intake of fruits and sweets | At 5 years follow-up | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At baseline | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At 1 year follow-up | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At 2 years follow-up | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At 3 years follow-up | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At 4 years follow-up | 
| Patient reported alcohol habits | Patient reported alcohol habis assessed by AUDIT C | At 5 years follow-up | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At baseline | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At 1 year follow-up | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At 2 years follow-up | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At 3 years follow-up | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At 4 years follow-up | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a simple self-assessment form that shows a measure of the patient's mood. | At 5 years follow-up | 
| Health literacy | Health literacy assessed with the Swedish Functional Health Literacy scale | At 2 years follow-up | 
| Health literacy | Health literacy assessed with the Swedish Functional Health Literacy scale | At 3 years follow-up | 
| Health literacy | Health literacy assessed with the Swedish Functional Health Literacy scale | At 5 years follow-up | 
| Clinical examination of the knees | Clinical examination to assessing clinical knee OA | At baseline | 
| Clinical examination of the knees | Clinical examination to assessing clinical knee OA | At 2 years follow-up | 
| Clinical examination of the knees | Clinical examination to assessing clinical knee OA | At 5 years follow-up | 
| Clinical examination of the hands | Clinical examination of the hands assessing clinical hand OA | At baseline | 
| Clinical examination of the hands | Clinical examination of the hands assessing clinical hand OA | At 2 years follow-up | 
| Clinical examination of the hands | Clinical examination of the hands assessing clinical hand OA | At 5 years follow-up | 
| Blood pressure | Blood pressure assessed in sitting position after rest, mmHg | At baseline | 
| Blood pressure | Blood pressure assessed in sitting position after rest, mmHg | At 2 years follow-up | 
| Blood pressure | Blood pressure assessed in sitting position after rest, mmHg | At 5 years follow-up |