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The Halland Osteoarthritis Cohort

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04928170
Acronym
HALLOA
Enrollment
312
Registered
2021-06-16
Start date
2016-11-01
Completion date
2024-12-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Generalized, Osteoarthritis Hand, Osteoarthritis, Knee

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

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. 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.

Interventions

None listed

Sponsors

The Swedish Rheumatism Ass
CollaboratorOTHER
FoU Center Spenshult
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Knee pain

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical loadAt inclusionMovement behavior measured with a triaxle accelerometer at work and leisure over 7 days
One-leg riseAt baselineKnee strenght are assessed by one-leg rise
30s-chair stand testAt baselineKnee strenght are assessed by 30s-chair stand test
Maximal voluntary isometric contraction of QuadricepsAt baselineMaximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Hand strenghtAt baselineHand strenght are assessed by grippit (N)
FitnessAt 2 years follow-upFitness are assessed by Åstrands test
Pain thresholdsAt baselinepain 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 baselineKOOS 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).
Pain mannequinAt baselinePatient reported pain distribution
Pain intensityAt baselinePatient reported pain intensity by NRS scale 0-10 (best to worst)
Patient intensityAt 5 years follow-upPatient reported pain intensity by NRS scale 0-10 (best to worst)
Radiographic assessment of the handsAt 2 years follow-upRadiographic assessment of the hands.
Radiographic assessment of the kneesAt baselineradiographic assessment of tibiofemoral- and patellofemoral joint in the knee
BMI (kg/m2)At baselineweight (kg) and height (m) are meassured and BMI will be calculated
Abdominal circumference (cm)At baselineAbdominal circumference are meassured with measuring tape at navel height
Body compositionAt baselineBody composition are assessed by Inbody 770, which gives data on proportion of muscle and body fat (separate meassures on visceral fat
GlucosAt BaselineFasting glucos (mmol/L) meassured in serum
HbA1cAt baselineHbA1c (mmol/mol) meassured in serum
Total-cholesterolAt baselineTotal-cholesterol (mmol/L) meassured in serum
TriglyceridesAt baselineTriglycerides (mmol/L) meassured in serum
LDL-cholesterolAt baselineLDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterolAt baselineHDL-cholesterol (mmol/L) meassured in serum
Sensitive C-Reactive Protein (CRP)At baselinesensitive CRP (g/L) meassured in serum
Interleukin-1 (IL-1)At baselineIL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)At baselineIL-6 (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)At baselineTNF-alfa (pg/mL) meassured in plasma with ELISA
LeptinAt baselineLeptin (ng/mL) meassured in serum with ELISA
Galectin-1At baselineGalectin-1 (ng/mL) meassured in plasma with ELISA

Secondary

MeasureTime frameDescription
Patient reported physical activityAt baselinePatient reported physical activity with questions duration and intensity according to WHO recommendations
Patient reported smoking and snuff habitsAt baselinePatient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Patient reported dietsAt baselinePatient reported diets and intake of fruits and sweets
Patient reported alcohol habitsAt baselinePatient reported alcohol habis assessed by AUDIT C
Hospital Anxiety and Depression Scale (HADS)At baselineHADS is a simple self-assessment form that shows a measure of the patient's mood.
Health literacyAt 2 years follow-upHealth literacy assessed with the Swedish Functional Health Literacy scale
Clinical examination of the kneesAt baselineClinical examination to assessing clinical knee OA
Clinical examination of the handsAt baselineClinical examination of the hands assessing clinical hand OA
Blood pressureAt baselineBlood pressure assessed in sitting position after rest, mmHg
Blood samples for biobankingAt baselineserum and plasma for biobanking in -70 degrees celcius

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026