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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04928170
Other study ID # HALLOA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2016
Est. completion date October 1, 2024

Study information

Verified date May 2021
Source FoU Center Spenshult
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 information / eligibility

Status Active, not recruiting
Enrollment 312
Est. completion date October 1, 2024
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: Knee pain Exclusion Criteria: Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Spenshult Research and Development center (FoU Spenshult) Halmstad

Sponsors (2)

Lead Sponsor Collaborator
FoU Center Spenshult The Swedish Rheumatism Ass

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary BMI (kg/m2) weight (kg) and height (m) are meassured and BMI will be calculated At baseline
Primary BMI (kg/m2) weight (kg) and height (m) are meassured and BMI will be calculated At 2 years follow-up
Primary BMI (kg/m2) weight (kg) and height (m) are meassured and BMI will be calculated At 5 years follow-up
Primary Abdominal circumference (cm) Abdominal circumference are meassured with measuring tape at navel height At baseline
Primary Abdominal circumference (cm) Abdominal circumference are meassured with measuring tape at navel height At 2 years follow-up
Primary Abdominal circumference (cm) Abdominal circumference are meassured with measuring tape at navel height At 5 years follow-up
Primary 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
Primary 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
Primary 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
Primary Glucos Fasting glucos (mmol/L) meassured in serum At Baseline
Primary Glucos Fasting glucos (mmol/L) meassured in serum At 1 year follow-up
Primary Glucos Fasting glucos (mmol/L) meassured in serum At 2 years follow-up
Primary Glucos Fasting glucos (mmol/L) meassured in serum At 3 years follow-up
Primary Glucos Fasting glucos (mmol/L) meassured in serum At 4 years follow-up
Primary Glucos Fasting glucos (mmol/L) meassured in serum At 5 years follow-up
Primary HbA1c HbA1c (mmol/mol) meassured in serum At baseline
Primary HbA1c HbA1c (mmol/mol) meassured in serum At 1 year follow-up
Primary HbA1c HbA1c (mmol/mol) meassured in serum At 2 years follow-up
Primary HbA1c HbA1c (mmol/mol) meassured in serum At 3 years follow-up
Primary HbA1c HbA1c (mmol/mol) meassured in serum At 4 years follow-up
Primary HbA1c HbA1c (mmol/mol) meassured in serum At 5 years follow-up
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At baseline
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At 1 year follow-up
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At 2 years follow-up
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At 3 years follow-up
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At 4 years follow-up
Primary Total-cholesterol Total-cholesterol (mmol/L) meassured in serum At 5 years follow-up
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At baseline
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At 1 year follow-up
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At 2 years follow-up
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At 3 years follow-up
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At 4 years follow-up
Primary Triglycerides Triglycerides (mmol/L) meassured in serum At 5 years follow-up
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At baseline
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At 1 year follow-up
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At 2 years follow-up
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At 3 years follow-up
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At 4 years follow-up
Primary LDL-cholesterol LDL-cholesterol (mmol/L) meassured in serum At 5 years follow-up
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At baseline
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At 1 year follow-up
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At 2 years follow-up
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At 3 years follow-up
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At 4 years follow-up
Primary HDL-cholesterol HDL-cholesterol (mmol/L) meassured in serum At 5 years follow-up
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At baseline
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At 1 year follow-up
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At 2 years follow-up
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At 3 years follow-up
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At 4 years follow-up
Primary Sensitive C-Reactive Protein (CRP) sensitive CRP (g/L) meassured in serum At 5 years follow-up
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At baseline
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At 1 year follow-up
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At 2 years follow-up
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At 3 years follow-up
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At 4 years follow-up
Primary Interleukin-1 (IL-1) IL-1 (pg/mL) meassured in plasma with ELISA At 5 years follow-up
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At baseline
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At 1 year follow-up
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At 2 years follow-up
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At 3 years follow-up
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At 4 years follow-up
Primary Interleukin-6 (IL-6) IL-6 (pg/mL) meassured in plasma with ELISA At 5 years follow-up
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At baseline
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At 1 year follow-up
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At 2 years follow-up
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At 3 years folllow-up
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At 4 years follow-up
Primary Tumor Necrosis Factor-alfa (TNF-alfa) TNF-alfa (pg/mL) meassured in plasma with ELISA At 5 years follow-up
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At baseline
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At 1 year follow-up
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At 2 years follow-up
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At 3 years follow-up
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At 4 years follow-up
Primary Leptin Leptin (ng/mL) meassured in serum with ELISA At 5 years follow-up
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At baseline
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At 1 year follow-up
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At 2 years follow-up
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At 3 years follow-up
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At 4 years follow-up
Primary Galectin-1 Galectin-1 (ng/mL) meassured in plasma with ELISA At 5 years follow-up
Primary One-leg rise Knee strenght are assessed by one-leg rise At baseline
Primary One-leg rise Knee strenght are assessed by one-leg rise At 2 years follow-up
Primary One-leg rise Knee strenght are assessed by one-leg rise At 5 years follow-up
Primary 30s-chair stand test Knee strenght are assessed by 30s-chair stand test At baseline
Primary 30s-chair stand test Knee strenght are assessed by 30s-chair stand test At 2 years follow-up
Primary 30s-chair stand test Knee strenght are assessed by 30s-chair stand test At 5 years follow-up
Primary Maximal voluntary isometric contraction of Quadriceps Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) At baseline
Primary Maximal voluntary isometric contraction of Quadriceps Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) At 2 years follow-up
Primary Maximal voluntary isometric contraction of Quadriceps Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N) At 5 years follow-up
Primary Hand strenght Hand strenght are assessed by grippit (N) At baseline
Primary Hand strenght Hand strenght are assessed by grippit (N) At 2 years follow-up
Primary Hand strenght Hand strenght are assessed by grippit (N) At 5 years follow-up
Primary Fitness Fitness are assessed by Åstrands test At 2 years follow-up
Primary Fitness Fitness are assessed by Åstrands test At 5 years follow-up
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Pain mannequin Patient reported pain distribution At baseline
Primary Pain mannequin Patient reported pain distribution At 1 year follow-up
Primary Pain mannequin Patient reported pain distribution At 2 years follow-up
Primary Pain mannequin Patient reported pain distribution At 3 years follow-up
Primary Pain mannequin Patient reported pain distribution At 4 years follow-up
Primary Pain mannequin Patient reported pain distribution At 5 years follow-up
Primary Pain intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At baseline
Primary Pain intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At 1 year follow-up
Primary Pain intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At 2 years follow-up
Primary Pain intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At 3 years follow-up
Primary Pain intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At 4 years follow-up
Primary Patient intensity Patient reported pain intensity by NRS scale 0-10 (best to worst) At 5 years follow-up
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At baseline
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At 1 year follow-up
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At 2 years follow-up
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At 3 years follow-up
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At 4 years follow-up
Primary Radiographic assessment of the knees radiographic assessment of tibiofemoral- and patellofemoral joint in the knee At 5 years follow-up
Primary Radiographic assessment of the hands Radiographic assessment of the hands. At 2 years follow-up
Primary Radiographic assessment of the hands Radiographic assessment of the hands. At 5 years follow-up
Primary Mechanical load Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days At inclusion
Primary Mechanical load Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days At 2 years follow-up
Primary Mechanical load Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days At 5 years follow-up
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At baseline
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At 1 year follow-up
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At 2 years follow-up
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At 3 years follow-up
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At 4 years follow-up
Secondary Blood samples for biobanking serum and plasma for biobanking in -70 degrees celcius At 5 years follow-up
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At baseline
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At 1 year follow-up
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At 2 years follow-up
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At 3 years follow-up
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At 4 years follow-up
Secondary Patient reported physical activity Patient reported physical activity with questions duration and intensity according to WHO recommendations At 5 years follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At baseline
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At 1 year follow-up
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At 2 years follow-up
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At 3 years follow-up
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At 4 years follow-up
Secondary Patient reported diets Patient reported diets and intake of fruits and sweets At 5 years follow-up
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At baseline
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At 1 year follow-up
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At 2 years follow-up
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At 3 years follow-up
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At 4 years follow-up
Secondary Patient reported alcohol habits Patient reported alcohol habis assessed by AUDIT C At 5 years follow-up
Secondary Hospital Anxiety and Depression Scale (HADS) HADS is a simple self-assessment form that shows a measure of the patient's mood. At baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Health literacy Health literacy assessed with the Swedish Functional Health Literacy scale At 2 years follow-up
Secondary Health literacy Health literacy assessed with the Swedish Functional Health Literacy scale At 3 years follow-up
Secondary Health literacy Health literacy assessed with the Swedish Functional Health Literacy scale At 5 years follow-up
Secondary Clinical examination of the knees Clinical examination to assessing clinical knee OA At baseline
Secondary Clinical examination of the knees Clinical examination to assessing clinical knee OA At 2 years follow-up
Secondary Clinical examination of the knees Clinical examination to assessing clinical knee OA At 5 years follow-up
Secondary Clinical examination of the hands Clinical examination of the hands assessing clinical hand OA At baseline
Secondary Clinical examination of the hands Clinical examination of the hands assessing clinical hand OA At 2 years follow-up
Secondary Clinical examination of the hands Clinical examination of the hands assessing clinical hand OA At 5 years follow-up
Secondary Blood pressure Blood pressure assessed in sitting position after rest, mmHg At baseline
Secondary Blood pressure Blood pressure assessed in sitting position after rest, mmHg At 2 years follow-up
Secondary Blood pressure Blood pressure assessed in sitting position after rest, mmHg At 5 years follow-up
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