Spenshult Research and Development center (FoU Spenshult)
Halmstad, SE-30274, Sweden
NCT Number: NCT04928170
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
This study is active but is not currently recruiting participants.
30 year–65 year
All sexes
Observational
Halmstad, SE-30274, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Knee pain
Exclusion criteria
Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Time frame: At baseline
weight (kg) and height (m) are meassured and BMI will be calculated
Time frame: At 2 years follow-up
weight (kg) and height (m) are meassured and BMI will be calculated
Time frame: At 5 years follow-up
weight (kg) and height (m) are meassured and BMI will be calculated
Time frame: At baseline
Abdominal circumference are meassured with measuring tape at navel height
Time frame: At 2 years follow-up
Abdominal circumference are meassured with measuring tape at navel height
Time frame: At 5 years follow-up
Abdominal circumference are meassured with measuring tape at navel height
Time frame: At baseline
Body composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat
Time frame: 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
Time frame: 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
Time frame: At Baseline
Fasting glucos (mmol/L) meassured in serum
Time frame: At 1 year follow-up
Fasting glucos (mmol/L) meassured in serum
Time frame: At 2 years follow-up
Fasting glucos (mmol/L) meassured in serum
Time frame: At 3 years follow-up
Fasting glucos (mmol/L) meassured in serum
Time frame: At 4 years follow-up
Fasting glucos (mmol/L) meassured in serum
Time frame: At 5 years follow-up
Fasting glucos (mmol/L) meassured in serum
Time frame: At baseline
HbA1c (mmol/mol) meassured in serum
Time frame: At 1 year follow-up
HbA1c (mmol/mol) meassured in serum
Time frame: At 2 years follow-up
HbA1c (mmol/mol) meassured in serum
Time frame: At 3 years follow-up
HbA1c (mmol/mol) meassured in serum
Time frame: At 4 years follow-up
HbA1c (mmol/mol) meassured in serum
Time frame: At 5 years follow-up
HbA1c (mmol/mol) meassured in serum
Time frame: At baseline
Total-cholesterol (mmol/L) meassured in serum
Time frame: At 1 year follow-up
Total-cholesterol (mmol/L) meassured in serum
Time frame: At 2 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Time frame: At 3 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Time frame: At 4 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Time frame: At 5 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Time frame: At baseline
Triglycerides (mmol/L) meassured in serum
Time frame: At 1 year follow-up
Triglycerides (mmol/L) meassured in serum
Time frame: At 2 years follow-up
Triglycerides (mmol/L) meassured in serum
Time frame: At 3 years follow-up
Triglycerides (mmol/L) meassured in serum
Time frame: At 4 years follow-up
Triglycerides (mmol/L) meassured in serum
Time frame: At 5 years follow-up
Triglycerides (mmol/L) meassured in serum
Time frame: At baseline
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At 1 year follow-up
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At 2 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At 3 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At 4 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At 5 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
Time frame: At baseline
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At 1 year follow-up
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At 2 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At 3 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At 4 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At 5 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Time frame: At baseline
sensitive CRP (g/L) meassured in serum
Time frame: At 1 year follow-up
sensitive CRP (g/L) meassured in serum
Time frame: At 2 years follow-up
sensitive CRP (g/L) meassured in serum
Time frame: At 3 years follow-up
sensitive CRP (g/L) meassured in serum
Time frame: At 4 years follow-up
sensitive CRP (g/L) meassured in serum
Time frame: At 5 years follow-up
sensitive CRP (g/L) meassured in serum
Time frame: At baseline
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At 1 year follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At 2 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At 3 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At 4 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At 5 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Time frame: At baseline
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At 1 year follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At 2 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At 3 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At 4 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At 5 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Time frame: At baseline
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At 1 year follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At 2 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At 3 years folllow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At 4 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At 5 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Time frame: At baseline
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At 1 year follow-up
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At 2 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At 3 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At 4 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At 5 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Time frame: At baseline
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At 1 year follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At 2 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At 3 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At 4 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At 5 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Time frame: At baseline
Knee strenght are assessed by one-leg rise
Time frame: At 2 years follow-up
Knee strenght are assessed by one-leg rise
Time frame: At 5 years follow-up
Knee strenght are assessed by one-leg rise
Time frame: At baseline
Knee strenght are assessed by 30s-chair stand test
Time frame: At 2 years follow-up
Knee strenght are assessed by 30s-chair stand test
Time frame: At 5 years follow-up
Knee strenght are assessed by 30s-chair stand test
Time frame: At baseline
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Time frame: At 2 years follow-up
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Time frame: At 5 years follow-up
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Time frame: At baseline
Hand strenght are assessed by grippit (N)
Time frame: At 2 years follow-up
Hand strenght are assessed by grippit (N)
Time frame: At 5 years follow-up
Hand strenght are assessed by grippit (N)
Time frame: At 2 years follow-up
Fitness are assessed by Åstrands test
Time frame: At 5 years follow-up
Fitness are assessed by Åstrands test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At baseline
Patient reported pain distribution
Time frame: At 1 year follow-up
Patient reported pain distribution
Time frame: At 2 years follow-up
Patient reported pain distribution
Time frame: At 3 years follow-up
Patient reported pain distribution
Time frame: At 4 years follow-up
Patient reported pain distribution
Time frame: At 5 years follow-up
Patient reported pain distribution
Time frame: At baseline
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At 1 year follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At 2 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At 3 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At 4 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At 5 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Time frame: At baseline
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 1 year follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 2 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 3 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 4 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 5 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Time frame: At 2 years follow-up
Radiographic assessment of the hands.
Time frame: At 5 years follow-up
Radiographic assessment of the hands.
Time frame: At inclusion
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Time frame: At 2 years follow-up
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Time frame: At 5 years follow-up
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Time frame: At baseline
serum and plasma for biobanking in -70 degrees celcius
Time frame: At 1 year follow-up
serum and plasma for biobanking in -70 degrees celcius
Time frame: At 2 years follow-up
serum and plasma for biobanking in -70 degrees celcius
Time frame: At 3 years follow-up
serum and plasma for biobanking in -70 degrees celcius
Time frame: At 4 years follow-up
serum and plasma for biobanking in -70 degrees celcius
Time frame: At 5 years follow-up
serum and plasma for biobanking in -70 degrees celcius
Time frame: At baseline
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At 1 year follow-up
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At 2 years follow-up
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At 3 years follow-up
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At 4 years follow-up
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At 5 years follow-up
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Time frame: At baseline
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At 1 years follow-up
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At 2 years follow-up
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At 3 years follow-up
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At 4 years follow-up
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At 5 years follow-up
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Time frame: At baseline
Patient reported diets and intake of fruits and sweets
Time frame: At 1 year follow-up
Patient reported diets and intake of fruits and sweets
Time frame: At 2 years follow-up
Patient reported diets and intake of fruits and sweets
Time frame: At 3 years follow-up
Patient reported diets and intake of fruits and sweets
Time frame: At 4 years follow-up
Patient reported diets and intake of fruits and sweets
Time frame: At 5 years follow-up
Patient reported diets and intake of fruits and sweets
Time frame: At baseline
Patient reported alcohol habis assessed by AUDIT C
Time frame: At 1 year follow-up
Patient reported alcohol habis assessed by AUDIT C
Time frame: At 2 years follow-up
Patient reported alcohol habis assessed by AUDIT C
Time frame: At 3 years follow-up
Patient reported alcohol habis assessed by AUDIT C
Time frame: At 4 years follow-up
Patient reported alcohol habis assessed by AUDIT C
Time frame: At 5 years follow-up
Patient reported alcohol habis assessed by AUDIT C
Time frame: At baseline
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 1 year follow-up
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 2 years follow-up
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 3 years follow-up
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 4 years follow-up
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 5 years follow-up
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Time frame: At 2 years follow-up
Health literacy assessed with the Swedish Functional Health Literacy scale
Time frame: At 3 years follow-up
Health literacy assessed with the Swedish Functional Health Literacy scale
Time frame: At 5 years follow-up
Health literacy assessed with the Swedish Functional Health Literacy scale
Time frame: At baseline
Clinical examination to assessing clinical knee OA
Time frame: At 2 years follow-up
Clinical examination to assessing clinical knee OA
Time frame: At 5 years follow-up
Clinical examination to assessing clinical knee OA
Time frame: At baseline
Clinical examination of the hands assessing clinical hand OA
Time frame: At 2 years follow-up
Clinical examination of the hands assessing clinical hand OA
Time frame: At 5 years follow-up
Clinical examination of the hands assessing clinical hand OA
Time frame: At baseline
Blood pressure assessed in sitting position after rest, mmHg
Time frame: At 2 years follow-up
Blood pressure assessed in sitting position after rest, mmHg
Time frame: At 5 years follow-up
Blood pressure assessed in sitting position after rest, mmHg
FoU Center Spenshult
Other
The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis
Acronym: HALLOA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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