Clinical trial NCT04928170: The Halland Osteoarthritis Cohort
Official title: The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Osteoarthritis Hand
Osteoarthritis Generalized
Lead sponsor: FoU Center Spenshult
Sponsor class: OTHER
Collaborators: name: The Swedish Rheumatism Ass
First posted: 2021-06-16
Enrollment: 312
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 306 individuals with knee pain without cruciate ligament injury, age between 30 and 65 years

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.

Eligibility criteria: Inclusion Criteria:

Knee pain

Exclusion Criteria:

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

Primary outcomes:
measure: BMI (kg/m2)
timeFrame: At baseline
measure: BMI (kg/m2)
timeFrame: At 2 years follow-up
measure: BMI (kg/m2)
timeFrame: At 5 years follow-up
measure: Abdominal circumference (cm)
timeFrame: At baseline
measure: Abdominal circumference (cm)
timeFrame: At 2 years follow-up
measure: Abdominal circumference (cm)
timeFrame: At 5 years follow-up
measure: Body composition
timeFrame: At baseline
measure: Body composition
timeFrame: At 2 years follow-up
measure: Body composition
timeFrame: At 5 years follow-up
measure: Glucos
timeFrame: At Baseline
measure: Glucos
timeFrame: At 1 year follow-up
measure: Glucos
timeFrame: At 2 years follow-up
measure: Glucos
timeFrame: At 3 years follow-up
measure: Glucos
timeFrame: At 4 years follow-up
measure: Glucos
timeFrame: At 5 years follow-up
measure: HbA1c
timeFrame: At baseline
measure: HbA1c
timeFrame: At 1 year follow-up
measure: HbA1c
timeFrame: At 2 years follow-up
measure: HbA1c
timeFrame: At 3 years follow-up
measure: HbA1c
timeFrame: At 4 years follow-up
measure: HbA1c
timeFrame: At 5 years follow-up
measure: Total-cholesterol
timeFrame: At baseline
measure: Total-cholesterol
timeFrame: At 1 year follow-up
measure: Total-cholesterol
timeFrame: At 2 years follow-up
measure: Total-cholesterol
timeFrame: At 3 years follow-up
measure: Total-cholesterol
timeFrame: At 4 years follow-up
measure: Total-cholesterol
timeFrame: At 5 years follow-up
measure: Triglycerides
timeFrame: At baseline
measure: Triglycerides
timeFrame: At 1 year follow-up
measure: Triglycerides
timeFrame: At 2 years follow-up
measure: Triglycerides
timeFrame: At 3 years follow-up
measure: Triglycerides
timeFrame: At 4 years follow-up
measure: Triglycerides
timeFrame: At 5 years follow-up
measure: LDL-cholesterol
timeFrame: At baseline
measure: LDL-cholesterol
timeFrame: At 1 year follow-up
measure: LDL-cholesterol
timeFrame: At 2 years follow-up
measure: LDL-cholesterol
timeFrame: At 3 years follow-up
measure: LDL-cholesterol
timeFrame: At 4 years follow-up
measure: LDL-cholesterol
timeFrame: At 5 years follow-up
measure: HDL-cholesterol
timeFrame: At baseline
measure: HDL-cholesterol
timeFrame: At 1 year follow-up
measure: HDL-cholesterol
timeFrame: At 2 years follow-up
measure: HDL-cholesterol
timeFrame: At 3 years follow-up
measure: HDL-cholesterol
timeFrame: At 4 years follow-up
measure: HDL-cholesterol
timeFrame: At 5 years follow-up
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At baseline
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At 1 year follow-up
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At 2 years follow-up
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At 3 years follow-up
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At 4 years follow-up
measure: Sensitive C-Reactive Protein (CRP)
timeFrame: At 5 years follow-up
measure: Interleukin-1 (IL-1)
timeFrame: At baseline
measure: Interleukin-1 (IL-1)
timeFrame: At 1 year follow-up
measure: Interleukin-1 (IL-1)
timeFrame: At 2 years follow-up
measure: Interleukin-1 (IL-1)
timeFrame: At 3 years follow-up
measure: Interleukin-1 (IL-1)
timeFrame: At 4 years follow-up
measure: Interleukin-1 (IL-1)
timeFrame: At 5 years follow-up
measure: Interleukin-6 (IL-6)
timeFrame: At baseline
measure: Interleukin-6 (IL-6)
timeFrame: At 1 year follow-up
measure: Interleukin-6 (IL-6)
timeFrame: At 2 years follow-up
measure: Interleukin-6 (IL-6)
timeFrame: At 3 years follow-up
measure: Interleukin-6 (IL-6)
timeFrame: At 4 years follow-up
measure: Interleukin-6 (IL-6)
timeFrame: At 5 years follow-up
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At baseline
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At 1 year follow-up
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At 2 years follow-up
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At 3 years folllow-up
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At 4 years follow-up
measure: Tumor Necrosis Factor-alfa (TNF-alfa)
timeFrame: At 5 years follow-up
measure: Leptin
timeFrame: At baseline
measure: Leptin
timeFrame: At 1 year follow-up
measure: Leptin
timeFrame: At 2 years follow-up
measure: Leptin
timeFrame: At 3 years follow-up
measure: Leptin
timeFrame: At 4 years follow-up
measure: Leptin
timeFrame: At 5 years follow-up
measure: Galectin-1
timeFrame: At baseline
measure: Galectin-1
timeFrame: At 1 year follow-up
measure: Galectin-1
timeFrame: At 2 years follow-up
measure: Galectin-1
timeFrame: At 3 years follow-up
measure: Galectin-1
timeFrame: At 4 years follow-up
measure: Galectin-1
timeFrame: At 5 years follow-up
measure: One-leg rise
timeFrame: At baseline
measure: One-leg rise
timeFrame: At 2 years follow-up
measure: One-leg rise
timeFrame: At 5 years follow-up
measure: 30s-chair stand test
timeFrame: At baseline
measure: 30s-chair stand test
timeFrame: At 2 years follow-up
measure: 30s-chair stand test
timeFrame: At 5 years follow-up
measure: Maximal voluntary isometric contraction of Quadriceps
timeFrame: At baseline
measure: Maximal voluntary isometric contraction of Quadriceps
timeFrame: At 2 years follow-up
measure: Maximal voluntary isometric contraction of Quadriceps
timeFrame: At 5 years follow-up
measure: Hand strenght
timeFrame: At baseline
measure: Hand strenght
timeFrame: At 2 years follow-up
measure: Hand strenght
timeFrame: At 5 years follow-up
measure: Fitness
timeFrame: At 2 years follow-up
measure: Fitness
timeFrame: At 5 years follow-up
measure: Pain thresholds
timeFrame: At baseline
measure: Pain thresholds
timeFrame: At 2 years follow-up
measure: Pain thresholds
timeFrame: At 5 years follow-up
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At baseline
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At 1 year follow-up
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At 2 years follow-up
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At 3 years follow-up
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At 4 years follow-up
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: At 5 years follow-up
measure: Pain mannequin
timeFrame: At baseline
measure: Pain mannequin
timeFrame: At 1 year follow-up
measure: Pain mannequin
timeFrame: At 2 years follow-up
measure: Pain mannequin
timeFrame: At 3 years follow-up
measure: Pain mannequin
timeFrame: At 4 years follow-up
measure: Pain mannequin
timeFrame: At 5 years follow-up
measure: Pain intensity
timeFrame: At baseline
measure: Pain intensity
timeFrame: At 1 year follow-up
measure: Pain intensity
timeFrame: At 2 years follow-up
measure: Pain intensity
timeFrame: At 3 years follow-up
measure: Pain intensity
timeFrame: At 4 years follow-up
measure: Patient intensity
timeFrame: At 5 years follow-up
measure: Radiographic assessment of the knees
timeFrame: At baseline
measure: Radiographic assessment of the knees
timeFrame: At 1 year follow-up
measure: Radiographic assessment of the knees
timeFrame: At 2 years follow-up
measure: Radiographic assessment of the knees
timeFrame: At 3 years follow-up
measure: Radiographic assessment of the knees
timeFrame: At 4 years follow-up
measure: Radiographic assessment of the knees
timeFrame: At 5 years follow-up
measure: Radiographic assessment of the hands
timeFrame: At 2 years follow-up
measure: Radiographic assessment of the hands
timeFrame: At 5 years follow-up
measure: Mechanical load
timeFrame: At inclusion
measure: Mechanical load
timeFrame: At 2 years follow-up
measure: Mechanical load
timeFrame: At 5 years follow-up
Secondary outcomes:
measure: Blood samples for biobanking
timeFrame: At baseline
measure: Blood samples for biobanking
timeFrame: At 1 year follow-up
measure: Blood samples for biobanking
timeFrame: At 2 years follow-up
measure: Blood samples for biobanking
timeFrame: At 3 years follow-up
measure: Blood samples for biobanking
timeFrame: At 4 years follow-up
measure: Blood samples for biobanking
timeFrame: At 5 years follow-up
measure: Patient reported physical activity
timeFrame: At baseline
measure: Patient reported physical activity
timeFrame: At 1 year follow-up
measure: Patient reported physical activity
timeFrame: At 2 years follow-up
measure: Patient reported physical activity
timeFrame: At 3 years follow-up
measure: Patient reported physical activity
timeFrame: At 4 years follow-up
measure: Patient reported physical activity
timeFrame: At 5 years follow-up
measure: Patient reported smoking and snuff habits
timeFrame: At baseline
measure: Patient reported smoking and snuff habits
timeFrame: At 1 years follow-up
measure: Patient reported smoking and snuff habits
timeFrame: At 2 years follow-up
measure: Patient reported smoking and snuff habits
timeFrame: At 3 years follow-up
measure: Patient reported smoking and snuff habits
timeFrame: At 4 years follow-up
measure: Patient reported smoking and snuff habits
timeFrame: At 5 years follow-up
measure: Patient reported diets
timeFrame: At baseline
measure: Patient reported diets
timeFrame: At 1 year follow-up
measure: Patient reported diets
timeFrame: At 2 years follow-up
measure: Patient reported diets
timeFrame: At 3 years follow-up
measure: Patient reported diets
timeFrame: At 4 years follow-up
measure: Patient reported diets
timeFrame: At 5 years follow-up
measure: Patient reported alcohol habits
timeFrame: At baseline
measure: Patient reported alcohol habits
timeFrame: At 1 year follow-up
measure: Patient reported alcohol habits
timeFrame: At 2 years follow-up
measure: Patient reported alcohol habits
timeFrame: At 3 years follow-up
measure: Patient reported alcohol habits
timeFrame: At 4 years follow-up
measure: Patient reported alcohol habits
timeFrame: At 5 years follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 1 year follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 2 years follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 3 years follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 4 years follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 5 years follow-up
measure: Health literacy
timeFrame: At 2 years follow-up
measure: Health literacy
timeFrame: At 3 years follow-up
measure: Health literacy
timeFrame: At 5 years follow-up
measure: Clinical examination of the knees
timeFrame: At baseline
measure: Clinical examination of the knees
timeFrame: At 2 years follow-up
measure: Clinical examination of the knees
timeFrame: At 5 years follow-up
measure: Clinical examination of the hands
timeFrame: At baseline
measure: Clinical examination of the hands
timeFrame: At 2 years follow-up
measure: Clinical examination of the hands
timeFrame: At 5 years follow-up
measure: Blood pressure
timeFrame: At baseline
measure: Blood pressure
timeFrame: At 2 years follow-up
measure: Blood pressure
timeFrame: At 5 years follow-up
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Spenshult Research and Development center (FoU Spenshult)
Study officials:
affiliation: FoU Spenshult
name: Maria LE Andersson, ass.prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.