HALLOA: The Halland Osteoarthritis Cohort
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HALLOA 306 individuals with knee pain in the age between 30 and 65 years, without cruciate ligament injury |
Outcome Measures
Primary Outcome Measures
- BMI (kg/m2) [At baseline]
weight (kg) and height (m) are meassured and BMI will be calculated
- BMI (kg/m2) [At 2 years follow-up]
weight (kg) and height (m) are meassured and BMI will be calculated
- BMI (kg/m2) [At 5 years follow-up]
weight (kg) and height (m) are meassured and BMI will be calculated
- Abdominal circumference (cm) [At baseline]
Abdominal circumference are meassured with measuring tape at navel height
- Abdominal circumference (cm) [At 2 years follow-up]
Abdominal circumference are meassured with measuring tape at navel height
- Abdominal circumference (cm) [At 5 years follow-up]
Abdominal circumference are meassured with measuring tape at navel height
- Body composition [At baseline]
Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat
- Body composition [At 2 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
- 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 Baseline]
Fasting glucos (mmol/L) meassured in serum
- Glucos [At 1 year follow-up]
Fasting glucos (mmol/L) meassured in serum
- Glucos [At 2 years follow-up]
Fasting glucos (mmol/L) meassured in serum
- Glucos [At 3 years follow-up]
Fasting glucos (mmol/L) meassured in serum
- Glucos [At 4 years follow-up]
Fasting glucos (mmol/L) meassured in serum
- Glucos [At 5 years follow-up]
Fasting glucos (mmol/L) meassured in serum
- HbA1c [At baseline]
HbA1c (mmol/mol) meassured in serum
- HbA1c [At 1 year follow-up]
HbA1c (mmol/mol) meassured in serum
- HbA1c [At 2 years follow-up]
HbA1c (mmol/mol) meassured in serum
- HbA1c [At 3 years follow-up]
HbA1c (mmol/mol) meassured in serum
- HbA1c [At 4 years follow-up]
HbA1c (mmol/mol) meassured in serum
- HbA1c [At 5 years follow-up]
HbA1c (mmol/mol) meassured in serum
- Total-cholesterol [At baseline]
Total-cholesterol (mmol/L) meassured in serum
- Total-cholesterol [At 1 year follow-up]
Total-cholesterol (mmol/L) meassured in serum
- Total-cholesterol [At 2 years follow-up]
Total-cholesterol (mmol/L) meassured in serum
- Total-cholesterol [At 3 years follow-up]
Total-cholesterol (mmol/L) meassured in serum
- Total-cholesterol [At 4 years follow-up]
Total-cholesterol (mmol/L) meassured in serum
- Total-cholesterol [At 5 years follow-up]
Total-cholesterol (mmol/L) meassured in serum
- Triglycerides [At baseline]
Triglycerides (mmol/L) meassured in serum
- Triglycerides [At 1 year follow-up]
Triglycerides (mmol/L) meassured in serum
- Triglycerides [At 2 years follow-up]
Triglycerides (mmol/L) meassured in serum
- Triglycerides [At 3 years follow-up]
Triglycerides (mmol/L) meassured in serum
- Triglycerides [At 4 years follow-up]
Triglycerides (mmol/L) meassured in serum
- Triglycerides [At 5 years follow-up]
Triglycerides (mmol/L) meassured in serum
- LDL-cholesterol [At baseline]
LDL-cholesterol (mmol/L) meassured in serum
- LDL-cholesterol [At 1 year follow-up]
LDL-cholesterol (mmol/L) meassured in serum
- LDL-cholesterol [At 2 years follow-up]
LDL-cholesterol (mmol/L) meassured in serum
- LDL-cholesterol [At 3 years follow-up]
LDL-cholesterol (mmol/L) meassured in serum
- LDL-cholesterol [At 4 years follow-up]
LDL-cholesterol (mmol/L) meassured in serum
- LDL-cholesterol [At 5 years follow-up]
LDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At baseline]
HDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At 1 year follow-up]
HDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At 2 years follow-up]
HDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At 3 years follow-up]
HDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At 4 years follow-up]
HDL-cholesterol (mmol/L) meassured in serum
- HDL-cholesterol [At 5 years follow-up]
HDL-cholesterol (mmol/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At baseline]
sensitive CRP (g/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At 1 year follow-up]
sensitive CRP (g/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At 2 years follow-up]
sensitive CRP (g/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At 3 years follow-up]
sensitive CRP (g/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At 4 years follow-up]
sensitive CRP (g/L) meassured in serum
- Sensitive C-Reactive Protein (CRP) [At 5 years follow-up]
sensitive CRP (g/L) meassured in serum
- Interleukin-1 (IL-1) [At baseline]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-1 (IL-1) [At 1 year follow-up]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-1 (IL-1) [At 2 years follow-up]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-1 (IL-1) [At 3 years follow-up]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-1 (IL-1) [At 4 years follow-up]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-1 (IL-1) [At 5 years follow-up]
IL-1 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At baseline]
IL-6 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At 1 year follow-up]
IL-6 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At 2 years follow-up]
IL-6 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At 3 years follow-up]
IL-6 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At 4 years follow-up]
IL-6 (pg/mL) meassured in plasma with ELISA
- Interleukin-6 (IL-6) [At 5 years follow-up]
IL-6 (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At baseline]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At 1 year follow-up]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At 2 years follow-up]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At 3 years folllow-up]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At 4 years follow-up]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Tumor Necrosis Factor-alfa (TNF-alfa) [At 5 years follow-up]
TNF-alfa (pg/mL) meassured in plasma with ELISA
- Leptin [At baseline]
Leptin (ng/mL) meassured in serum with ELISA
- Leptin [At 1 year follow-up]
Leptin (ng/mL) meassured in serum with ELISA
- Leptin [At 2 years follow-up]
Leptin (ng/mL) meassured in serum with ELISA
- Leptin [At 3 years follow-up]
Leptin (ng/mL) meassured in serum with ELISA
- Leptin [At 4 years follow-up]
Leptin (ng/mL) meassured in serum with ELISA
- Leptin [At 5 years follow-up]
Leptin (ng/mL) meassured in serum with ELISA
- Galectin-1 [At baseline]
Galectin-1 (ng/mL) meassured in plasma with ELISA
- Galectin-1 [At 1 year follow-up]
Galectin-1 (ng/mL) meassured in plasma with ELISA
- Galectin-1 [At 2 years follow-up]
Galectin-1 (ng/mL) meassured in plasma with ELISA
- Galectin-1 [At 3 years follow-up]
Galectin-1 (ng/mL) meassured in plasma with ELISA
- Galectin-1 [At 4 years follow-up]
Galectin-1 (ng/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 baseline]
Knee strenght are assessed by one-leg rise
- One-leg rise [At 2 years follow-up]
Knee strenght are assessed by one-leg rise
- One-leg rise [At 5 years follow-up]
Knee strenght are assessed by one-leg rise
- 30s-chair stand test [At baseline]
Knee strenght are assessed by 30s-chair stand test
- 30s-chair stand test [At 2 years follow-up]
Knee strenght are assessed by 30s-chair stand test
- 30s-chair stand test [At 5 years follow-up]
Knee strenght are assessed by 30s-chair stand test
- Maximal voluntary isometric contraction of Quadriceps [At baseline]
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
- Maximal voluntary isometric contraction of Quadriceps [At 2 years follow-up]
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
- Maximal voluntary isometric contraction of Quadriceps [At 5 years follow-up]
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
- Hand strenght [At baseline]
Hand strenght are assessed by grippit (N)
- Hand strenght [At 2 years follow-up]
Hand strenght are assessed by grippit (N)
- Hand strenght [At 5 years follow-up]
Hand strenght are assessed by grippit (N)
- Fitness [At 2 years follow-up]
Fitness are assessed by Åstrands test
- Fitness [At 5 years follow-up]
Fitness are assessed by Åstrands test
- Pain thresholds [At baseline]
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
- Pain thresholds [At 2 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
- 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
- Knee injury and osteoarthritis outcome score (KOOS) [At baseline]
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).
- Knee injury and osteoarthritis outcome score (KOOS) [At 1 year 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).
- Knee injury and osteoarthritis outcome score (KOOS) [At 2 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).
- Knee injury and osteoarthritis outcome score (KOOS) [At 3 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).
- Knee injury and osteoarthritis outcome score (KOOS) [At 4 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).
- 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).
- Pain mannequin [At baseline]
Patient reported pain distribution
- Pain mannequin [At 1 year follow-up]
Patient reported pain distribution
- Pain mannequin [At 2 years follow-up]
Patient reported pain distribution
- Pain mannequin [At 3 years follow-up]
Patient reported pain distribution
- Pain mannequin [At 4 years follow-up]
Patient reported pain distribution
- Pain mannequin [At 5 years follow-up]
Patient reported pain distribution
- Pain intensity [At baseline]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Pain intensity [At 1 year follow-up]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Pain intensity [At 2 years follow-up]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Pain intensity [At 3 years follow-up]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Pain intensity [At 4 years follow-up]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Patient intensity [At 5 years follow-up]
Patient reported pain intensity by NRS scale 0-10 (best to worst)
- Radiographic assessment of the knees [At baseline]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- Radiographic assessment of the knees [At 1 year follow-up]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- Radiographic assessment of the knees [At 2 years follow-up]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- Radiographic assessment of the knees [At 3 years follow-up]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- Radiographic assessment of the knees [At 4 years follow-up]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- Radiographic assessment of the knees [At 5 years follow-up]
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
- 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]
Radiographic assessment of the hands.
- Mechanical load [At inclusion]
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
- Mechanical load [At 2 years follow-up]
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
- Mechanical load [At 5 years follow-up]
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Secondary Outcome Measures
- Blood samples for biobanking [At baseline]
serum and plasma for biobanking in -70 degrees celcius
- Blood samples for biobanking [At 1 year follow-up]
serum and plasma for biobanking in -70 degrees celcius
- Blood samples for biobanking [At 2 years follow-up]
serum and plasma for biobanking in -70 degrees celcius
- Blood samples for biobanking [At 3 years follow-up]
serum and plasma for biobanking in -70 degrees celcius
- Blood samples for biobanking [At 4 years follow-up]
serum and plasma for biobanking in -70 degrees celcius
- Blood samples for biobanking [At 5 years follow-up]
serum and plasma for biobanking in -70 degrees celcius
- Patient reported physical activity [At baseline]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported physical activity [At 1 year follow-up]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported physical activity [At 2 years follow-up]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported physical activity [At 3 years follow-up]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported physical activity [At 4 years follow-up]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported physical activity [At 5 years follow-up]
Patient reported physical activity with questions duration and intensity according to WHO recommendations
- Patient reported smoking and snuff habits [At baseline]
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
- Patient reported smoking and snuff habits [At 1 years follow-up]
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
- Patient reported smoking and snuff habits [At 2 years follow-up]
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
- Patient reported smoking and snuff habits [At 3 years follow-up]
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
- Patient reported smoking and snuff habits [At 4 years follow-up]
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
- 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
- Patient reported diets [At baseline]
Patient reported diets and intake of fruits and sweets
- Patient reported diets [At 1 year follow-up]
Patient reported diets and intake of fruits and sweets
- Patient reported diets [At 2 years follow-up]
Patient reported diets and intake of fruits and sweets
- Patient reported diets [At 3 years follow-up]
Patient reported diets and intake of fruits and sweets
- Patient reported diets [At 4 years follow-up]
Patient reported diets and intake of fruits and sweets
- Patient reported diets [At 5 years follow-up]
Patient reported diets and intake of fruits and sweets
- Patient reported alcohol habits [At baseline]
Patient reported alcohol habis assessed by AUDIT C
- Patient reported alcohol habits [At 1 year follow-up]
Patient reported alcohol habis assessed by AUDIT C
- Patient reported alcohol habits [At 2 years follow-up]
Patient reported alcohol habis assessed by AUDIT C
- Patient reported alcohol habits [At 3 years follow-up]
Patient reported alcohol habis assessed by AUDIT C
- Patient reported alcohol habits [At 4 years follow-up]
Patient reported alcohol habis assessed by AUDIT C
- Patient reported alcohol habits [At 5 years follow-up]
Patient reported alcohol habis assessed by AUDIT C
- Hospital Anxiety and Depression Scale (HADS) [At baseline]
HADS is a simple self-assessment form that shows a measure of the patient's mood.
- Hospital Anxiety and Depression Scale (HADS) [At 1 year follow-up]
HADS is a simple self-assessment form that shows a measure of the patient's mood.
- Hospital Anxiety and Depression Scale (HADS) [At 2 years follow-up]
HADS is a simple self-assessment form that shows a measure of the patient's mood.
- Hospital Anxiety and Depression Scale (HADS) [At 3 years follow-up]
HADS is a simple self-assessment form that shows a measure of the patient's mood.
- Hospital Anxiety and Depression Scale (HADS) [At 4 years follow-up]
HADS is a simple self-assessment form that shows a measure of the patient's mood.
- 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.
- Health literacy [At 2 years follow-up]
Health literacy assessed with the Swedish Functional Health Literacy scale
- Health literacy [At 3 years follow-up]
Health literacy assessed with the Swedish Functional Health Literacy scale
- Health literacy [At 5 years follow-up]
Health literacy assessed with the Swedish Functional Health Literacy scale
- Clinical examination of the knees [At baseline]
Clinical examination to assessing clinical knee OA
- Clinical examination of the knees [At 2 years follow-up]
Clinical examination to assessing clinical knee OA
- Clinical examination of the knees [At 5 years follow-up]
Clinical examination to assessing clinical knee OA
- Clinical examination of the hands [At baseline]
Clinical examination of the hands assessing clinical hand OA
- Clinical examination of the hands [At 2 years follow-up]
Clinical examination of the hands assessing clinical hand OA
- Clinical examination of the hands [At 5 years follow-up]
Clinical examination of the hands assessing clinical hand OA
- Blood pressure [At baseline]
Blood pressure assessed in sitting position after rest, mmHg
- Blood pressure [At 2 years follow-up]
Blood pressure assessed in sitting position after rest, mmHg
- Blood pressure [At 5 years follow-up]
Blood pressure assessed in sitting position after rest, mmHg
Eligibility Criteria
Criteria
Inclusion Criteria:
Knee pain
Exclusion Criteria:
Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spenshult Research and Development center (FoU Spenshult) | Halmstad | Sweden | SE-30274 |
Sponsors and Collaborators
- FoU Center Spenshult
- The Swedish Rheumatism Ass
Investigators
- Principal Investigator: Maria LE Andersson, ass.prof., FoU Spenshult
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HALLOA