The Halland Osteoarthritis Cohort

NCT04928170 | Active Not Recruiting

• 1 other identifier: HALLOA
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee; Osteoarthritis Hand; Osteoarthritis Generalized

Outcome Measures

Primary Outcomes (127)

• 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 Outcomes (48)

• Blood samples for biobanking

  At baseline

• Blood samples for biobanking

  At 1 year follow-up

• Blood samples for biobanking

  At 2 years follow-up

• Blood samples for biobanking

  At 3 years follow-up

• Blood samples for biobanking

  At 4 years follow-up

Study Arms (1)

HALLOA

306 individuals with knee pain in the age between 30 and 65 years, without cruciate ligament injury

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

306 individuals with knee pain without cruciate ligament injury, age between 30 and 65 years

You may qualify if:

• Knee pain

You may not qualify if:

• Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)

Sponsors & Collaborators

• FoU Center Spenshult: lead
• The Swedish Rheumatism Ass: collaborator

Study Sites (1)

Spenshult Research and Development center (FoU Spenshult)

Halmstad, SE-30274, Sweden

Location

Related Publications (6)

• Tornblom M, Haglund E, Bremander A, Nilsdotter A, Andersson ML, Hettiarachchi P, Johansson PJ, Svartengren M, Aili K. Associations between knee pain and knee-loading physical activities at work and leisure - a cross-sectional study based on accelerometer measurements. BMC Musculoskelet Disord. 2025 Apr 8;26(1):345. doi: 10.1186/s12891-025-08589-w.

  PMID: 40200207 DERIVED

• Brogren E, Andersson M, Westenius M, Wittrup J, Zimmerman M. Associations between hand osteoarthritis, obesity and lipid metabolism: a cross-sectional study of the Halland County Osteoarthritis (HALLOA) cohort. BMC Musculoskelet Disord. 2024 Nov 22;25(1):944. doi: 10.1186/s12891-024-08073-x.

  PMID: 39578778 DERIVED

• Tornblom M, Bremander A, Aili K, Andersson MLE, Nilsdotter A, Haglund E. Development of radiographic knee osteoarthritis and the associations to radiographic changes and baseline variables in individuals with knee pain: a 2-year longitudinal study. BMJ Open. 2024 Mar 8;14(3):e081999. doi: 10.1136/bmjopen-2023-081999.

  PMID: 38458788 DERIVED

• Andersson MLE, Thoren E, Sylwander C, Bergman S. Associations between chronic widespread pain, pressure pain thresholds, leptin, and metabolic factors in individuals with knee pain. BMC Musculoskelet Disord. 2023 Aug 9;24(1):639. doi: 10.1186/s12891-023-06773-4.

  PMID: 37559026 DERIVED

• Andersson M, Haglund E, Aili K, Bremander A, Bergman S. Associations between metabolic factors and radiographic knee osteoarthritis in early disease - a cross-sectional study of individuals with knee pain. BMC Musculoskelet Disord. 2022 Oct 28;23(1):938. doi: 10.1186/s12891-022-05881-x.

  PMID: 36307803 DERIVED

• Andersson MLE, Haglund E, Aili K, Bremander A, Bergman S. Cohort profile: the Halland osteoarthritis (HALLOA) cohort-from knee pain to osteoarthritis: a longitudinal observational study in Sweden. BMJ Open. 2022 Jul 14;12(7):e057086. doi: 10.1136/bmjopen-2021-057086.

  PMID: 35835523 DERIVED

Related Links

• Study protocol

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and EDTA plasma

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Maria LE Andersson, ass.prof.

  FoU Spenshult

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: June 16, 2021
• Study Start: November 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)