Osteoarthritis, KneeHALLOANCT04928170
The Halland Osteoarthritis Cohort
An observational study of Osteoarthritis, Knee and Osteoarthritis Hand, run by FoU Center Spenshult at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis Hand, Osteoarthritis Generalized
- How many people
- 312 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2016to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 306 individuals with knee pain without cruciate ligament injury, age between 30 and 65 years
Who may be able to join
- Knee pain
Who cannot join
- Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Spenshult Research and Development center (FoU Spenshult)
Halmstad, SE-30274
About this study
Official title: The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis
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
Read the 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.
- 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.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HALLOA | 306 individuals with knee pain in the age between 30 and 65 years, without cruciate ligament injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (kg/m2)
weight (kg) and height (m) are meassured and BMI will be calculated
Measured: At baseline
BMI (kg/m2)
weight (kg) and height (m) are meassured and BMI will be calculated
Measured: At 2 years follow-up
BMI (kg/m2)
weight (kg) and height (m) are meassured and BMI will be calculated
Measured: At 5 years follow-up
Abdominal circumference (cm)
Abdominal circumference are meassured with measuring tape at navel height
Measured: At baseline
Abdominal circumference (cm)
Abdominal circumference are meassured with measuring tape at navel height
Measured: At 2 years follow-up
Abdominal circumference (cm)
Abdominal circumference are meassured with measuring tape at navel height
Measured: 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
Measured: 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
Measured: 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
Measured: At 5 years follow-up
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At Baseline
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At 1 year follow-up
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At 2 years follow-up
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At 3 years follow-up
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At 4 years follow-up
Glucos
Fasting glucos (mmol/L) meassured in serum
Measured: At 5 years follow-up
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At baseline
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At 1 year follow-up
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At 2 years follow-up
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At 3 years follow-up
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At 4 years follow-up
HbA1c
HbA1c (mmol/mol) meassured in serum
Measured: At 5 years follow-up
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At baseline
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At 1 year follow-up
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At 2 years follow-up
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At 3 years follow-up
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At 4 years follow-up
Total-cholesterol
Total-cholesterol (mmol/L) meassured in serum
Measured: At 5 years follow-up
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At baseline
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At 1 year follow-up
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At 2 years follow-up
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At 3 years follow-up
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At 4 years follow-up
Triglycerides
Triglycerides (mmol/L) meassured in serum
Measured: At 5 years follow-up
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At baseline
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At 1 year follow-up
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At 2 years follow-up
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At 3 years follow-up
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At 4 years follow-up
LDL-cholesterol
LDL-cholesterol (mmol/L) meassured in serum
Measured: At 5 years follow-up
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At baseline
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At 1 year follow-up
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At 2 years follow-up
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At 3 years follow-up
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At 4 years follow-up
HDL-cholesterol
HDL-cholesterol (mmol/L) meassured in serum
Measured: At 5 years follow-up
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At baseline
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At 1 year follow-up
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At 2 years follow-up
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At 3 years follow-up
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At 4 years follow-up
Sensitive C-Reactive Protein (CRP)
sensitive CRP (g/L) meassured in serum
Measured: At 5 years follow-up
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At baseline
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At 1 year follow-up
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At 2 years follow-up
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At 3 years follow-up
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At 4 years follow-up
Interleukin-1 (IL-1)
IL-1 (pg/mL) meassured in plasma with ELISA
Measured: At 5 years follow-up
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At baseline
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At 1 year follow-up
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At 2 years follow-up
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At 3 years follow-up
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At 4 years follow-up
Interleukin-6 (IL-6)
IL-6 (pg/mL) meassured in plasma with ELISA
Measured: At 5 years follow-up
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At baseline
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At 1 year follow-up
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At 2 years follow-up
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At 3 years folllow-up
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At 4 years follow-up
Tumor Necrosis Factor-alfa (TNF-alfa)
TNF-alfa (pg/mL) meassured in plasma with ELISA
Measured: At 5 years follow-up
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At baseline
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At 1 year follow-up
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At 2 years follow-up
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At 3 years follow-up
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At 4 years follow-up
Leptin
Leptin (ng/mL) meassured in serum with ELISA
Measured: At 5 years follow-up
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At baseline
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At 1 year follow-up
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At 2 years follow-up
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At 3 years follow-up
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At 4 years follow-up
Galectin-1
Galectin-1 (ng/mL) meassured in plasma with ELISA
Measured: At 5 years follow-up
One-leg rise
Knee strenght are assessed by one-leg rise
Measured: At baseline
One-leg rise
Knee strenght are assessed by one-leg rise
Measured: At 2 years follow-up
One-leg rise
Knee strenght are assessed by one-leg rise
Measured: At 5 years follow-up
30s-chair stand test
Knee strenght are assessed by 30s-chair stand test
Measured: At baseline
30s-chair stand test
Knee strenght are assessed by 30s-chair stand test
Measured: At 2 years follow-up
30s-chair stand test
Knee strenght are assessed by 30s-chair stand test
Measured: At 5 years follow-up
Maximal voluntary isometric contraction of Quadriceps
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Measured: At baseline
Maximal voluntary isometric contraction of Quadriceps
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Measured: At 2 years follow-up
Maximal voluntary isometric contraction of Quadriceps
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Measured: At 5 years follow-up
Hand strenght
Hand strenght are assessed by grippit (N)
Measured: At baseline
Hand strenght
Hand strenght are assessed by grippit (N)
Measured: At 2 years follow-up
Hand strenght
Hand strenght are assessed by grippit (N)
Measured: At 5 years follow-up
Fitness
Fitness are assessed by Åstrands test
Measured: At 2 years follow-up
Fitness
Fitness are assessed by Åstrands test
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 5 years follow-up
Pain mannequin
Patient reported pain distribution
Measured: At baseline
Pain mannequin
Patient reported pain distribution
Measured: At 1 year follow-up
Pain mannequin
Patient reported pain distribution
Measured: At 2 years follow-up
Pain mannequin
Patient reported pain distribution
Measured: At 3 years follow-up
Pain mannequin
Patient reported pain distribution
Measured: At 4 years follow-up
Pain mannequin
Patient reported pain distribution
Measured: At 5 years follow-up
Pain intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At baseline
Pain intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At 1 year follow-up
Pain intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At 2 years follow-up
Pain intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At 3 years follow-up
Pain intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At 4 years follow-up
Patient intensity
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Measured: At 5 years follow-up
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At baseline
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At 1 year follow-up
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At 2 years follow-up
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At 3 years follow-up
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At 4 years follow-up
Radiographic assessment of the knees
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Measured: At 5 years follow-up
Radiographic assessment of the hands
Radiographic assessment of the hands.
Measured: At 2 years follow-up
Radiographic assessment of the hands
Radiographic assessment of the hands.
Measured: At 5 years follow-up
Mechanical load
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Measured: At inclusion
Mechanical load
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Measured: At 2 years follow-up
Mechanical load
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Measured: At 5 years follow-up
Secondary outcomes (48)
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At baseline
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At 1 year follow-up
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At 2 years follow-up
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At 3 years follow-up
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At 4 years follow-up
Blood samples for biobanking
serum and plasma for biobanking in -70 degrees celcius
Measured: At 5 years follow-up
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At baseline
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At 1 year follow-up
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At 2 years follow-up
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At 3 years follow-up
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At 4 years follow-up
Patient reported physical activity
Patient reported physical activity with questions duration and intensity according to WHO recommendations
Measured: At 5 years follow-up
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At baseline
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At 1 years follow-up
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At 2 years follow-up
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At 3 years follow-up
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At 4 years follow-up
Patient reported smoking and snuff habits
Patient reported smoking habits, year for smoke or snuff cessation, number of cigarettes or amount of snuff
Measured: At 5 years follow-up
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At baseline
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At 1 year follow-up
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At 2 years follow-up
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At 3 years follow-up
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At 4 years follow-up
Patient reported diets
Patient reported diets and intake of fruits and sweets
Measured: At 5 years follow-up
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At baseline
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At 1 year follow-up
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At 2 years follow-up
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At 3 years follow-up
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At 4 years follow-up
Patient reported alcohol habits
Patient reported alcohol habis assessed by AUDIT C
Measured: At 5 years follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At baseline
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At 1 year follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At 2 years follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At 3 years follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At 4 years follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple self-assessment form that shows a measure of the patient's mood.
Measured: At 5 years follow-up
Health literacy
Health literacy assessed with the Swedish Functional Health Literacy scale
Measured: At 2 years follow-up
Health literacy
Health literacy assessed with the Swedish Functional Health Literacy scale
Measured: At 3 years follow-up
Health literacy
Health literacy assessed with the Swedish Functional Health Literacy scale
Measured: At 5 years follow-up
Clinical examination of the knees
Clinical examination to assessing clinical knee OA
Measured: At baseline
Clinical examination of the knees
Clinical examination to assessing clinical knee OA
Measured: At 2 years follow-up
Clinical examination of the knees
Clinical examination to assessing clinical knee OA
Measured: At 5 years follow-up
Clinical examination of the hands
Clinical examination of the hands assessing clinical hand OA
Measured: At baseline
Clinical examination of the hands
Clinical examination of the hands assessing clinical hand OA
Measured: At 2 years follow-up
Clinical examination of the hands
Clinical examination of the hands assessing clinical hand OA
Measured: At 5 years follow-up
Blood pressure
Blood pressure assessed in sitting position after rest, mmHg
Measured: At baseline
Blood pressure
Blood pressure assessed in sitting position after rest, mmHg
Measured: At 2 years follow-up
Blood pressure
Blood pressure assessed in sitting position after rest, mmHg
Measured: At 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Nov 2016
- Primary completion1 Oct 2019
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- FoU Center Spenshult
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Rheumatism Ass
- Responsible party
- Sponsor
- Investigators
- Maria LE Andersson, ass.prof., Principal investigator, FoU Spenshult
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928170
- Sponsor's protocol ID
- HALLOA
- Acronym
- HALLOA
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40200207Brogren 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.
PubMed 39578778Tornblom 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.
PubMed 38458788Andersson 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.
PubMed 37559026Andersson 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.
PubMed 36307803Andersson 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.
PubMed 35835523
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Halland Osteoarthritis (HALLOA) Cohort Study - a Five-year Observational Longitudinal Study With Focus on Metabolic Osteoarthritis
- ClinicalTrials.gov ID
- NCT04928170
- Acronym / sponsor ID
- HALLOA / HALLOA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (actual)
- Lead sponsor
- FoU Center SpenshultUniversity, hospital or other
- Collaborators
- The Swedish Rheumatism Ass
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HALLOA | – | –306 individuals with knee pain in the age between 30 and 65 years, without cruciate ligament injury |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 306 individuals with knee pain without cruciate ligament injury, age between 30 and 65 years
Key inclusion criteria (1 listed)
- Knee pain
Key exclusion criteria (1 listed)
- Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI (kg/m2)
Time frame: At baseline
weight (kg) and height (m) are meassured and BMI will be calculated
BMI (kg/m2)
Time frame: At 2 years follow-up
weight (kg) and height (m) are meassured and BMI will be calculated
BMI (kg/m2)
Time frame: At 5 years follow-up
weight (kg) and height (m) are meassured and BMI will be calculated
Abdominal circumference (cm)
Time frame: At baseline
Abdominal circumference are meassured with measuring tape at navel height
Abdominal circumference (cm)
Time frame: At 2 years follow-up
Abdominal circumference are meassured with measuring tape at navel height
Abdominal circumference (cm)
Time frame: At 5 years follow-up
Abdominal circumference are meassured with measuring tape at navel height
Body composition
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
Body composition
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
Body composition
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
Glucos
Time frame: At Baseline
Fasting glucos (mmol/L) meassured in serum
Glucos
Time frame: At 1 year follow-up
Fasting glucos (mmol/L) meassured in serum
Glucos
Time frame: At 2 years follow-up
Fasting glucos (mmol/L) meassured in serum
Glucos
Time frame: At 3 years follow-up
Fasting glucos (mmol/L) meassured in serum
Glucos
Time frame: At 4 years follow-up
Fasting glucos (mmol/L) meassured in serum
Glucos
Time frame: At 5 years follow-up
Fasting glucos (mmol/L) meassured in serum
HbA1c
Time frame: At baseline
HbA1c (mmol/mol) meassured in serum
HbA1c
Time frame: At 1 year follow-up
HbA1c (mmol/mol) meassured in serum
HbA1c
Time frame: At 2 years follow-up
HbA1c (mmol/mol) meassured in serum
HbA1c
Time frame: At 3 years follow-up
HbA1c (mmol/mol) meassured in serum
HbA1c
Time frame: At 4 years follow-up
HbA1c (mmol/mol) meassured in serum
HbA1c
Time frame: At 5 years follow-up
HbA1c (mmol/mol) meassured in serum
Total-cholesterol
Time frame: At baseline
Total-cholesterol (mmol/L) meassured in serum
Total-cholesterol
Time frame: At 1 year follow-up
Total-cholesterol (mmol/L) meassured in serum
Total-cholesterol
Time frame: At 2 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Total-cholesterol
Time frame: At 3 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Total-cholesterol
Time frame: At 4 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Total-cholesterol
Time frame: At 5 years follow-up
Total-cholesterol (mmol/L) meassured in serum
Triglycerides
Time frame: At baseline
Triglycerides (mmol/L) meassured in serum
Triglycerides
Time frame: At 1 year follow-up
Triglycerides (mmol/L) meassured in serum
Triglycerides
Time frame: At 2 years follow-up
Triglycerides (mmol/L) meassured in serum
Triglycerides
Time frame: At 3 years follow-up
Triglycerides (mmol/L) meassured in serum
Triglycerides
Time frame: At 4 years follow-up
Triglycerides (mmol/L) meassured in serum
Triglycerides
Time frame: At 5 years follow-up
Triglycerides (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At baseline
LDL-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At 1 year follow-up
LDL-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At 2 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At 3 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At 4 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
LDL-cholesterol
Time frame: At 5 years follow-up
LDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At baseline
HDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At 1 year follow-up
HDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At 2 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At 3 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At 4 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
HDL-cholesterol
Time frame: At 5 years follow-up
HDL-cholesterol (mmol/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At baseline
sensitive CRP (g/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At 1 year follow-up
sensitive CRP (g/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At 2 years follow-up
sensitive CRP (g/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At 3 years follow-up
sensitive CRP (g/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At 4 years follow-up
sensitive CRP (g/L) meassured in serum
Sensitive C-Reactive Protein (CRP)
Time frame: At 5 years follow-up
sensitive CRP (g/L) meassured in serum
Interleukin-1 (IL-1)
Time frame: At baseline
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-1 (IL-1)
Time frame: At 1 year follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-1 (IL-1)
Time frame: At 2 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-1 (IL-1)
Time frame: At 3 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-1 (IL-1)
Time frame: At 4 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-1 (IL-1)
Time frame: At 5 years follow-up
IL-1 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At baseline
IL-6 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At 1 year follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At 2 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At 3 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At 4 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Interleukin-6 (IL-6)
Time frame: At 5 years follow-up
IL-6 (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At baseline
TNF-alfa (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At 1 year follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At 2 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At 3 years folllow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At 4 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Tumor Necrosis Factor-alfa (TNF-alfa)
Time frame: At 5 years follow-up
TNF-alfa (pg/mL) meassured in plasma with ELISA
Leptin
Time frame: At baseline
Leptin (ng/mL) meassured in serum with ELISA
Leptin
Time frame: At 1 year follow-up
Leptin (ng/mL) meassured in serum with ELISA
Leptin
Time frame: At 2 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Leptin
Time frame: At 3 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Leptin
Time frame: At 4 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Leptin
Time frame: At 5 years follow-up
Leptin (ng/mL) meassured in serum with ELISA
Galectin-1
Time frame: At baseline
Galectin-1 (ng/mL) meassured in plasma with ELISA
Galectin-1
Time frame: At 1 year follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Galectin-1
Time frame: At 2 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Galectin-1
Time frame: At 3 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Galectin-1
Time frame: At 4 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
Galectin-1
Time frame: At 5 years follow-up
Galectin-1 (ng/mL) meassured in plasma with ELISA
One-leg rise
Time frame: At baseline
Knee strenght are assessed by one-leg rise
One-leg rise
Time frame: At 2 years follow-up
Knee strenght are assessed by one-leg rise
One-leg rise
Time frame: At 5 years follow-up
Knee strenght are assessed by one-leg rise
30s-chair stand test
Time frame: At baseline
Knee strenght are assessed by 30s-chair stand test
30s-chair stand test
Time frame: At 2 years follow-up
Knee strenght are assessed by 30s-chair stand test
30s-chair stand test
Time frame: At 5 years follow-up
Knee strenght are assessed by 30s-chair stand test
Maximal voluntary isometric contraction of Quadriceps
Time frame: At baseline
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Maximal voluntary isometric contraction of Quadriceps
Time frame: At 2 years follow-up
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Maximal voluntary isometric contraction of Quadriceps
Time frame: At 5 years follow-up
Maximal voluntary isometric contraction of Quadriceps assessed by dynamometer (N)
Hand strenght
Time frame: At baseline
Hand strenght are assessed by grippit (N)
Hand strenght
Time frame: At 2 years follow-up
Hand strenght are assessed by grippit (N)
Hand strenght
Time frame: At 5 years follow-up
Hand strenght are assessed by grippit (N)
Fitness
Time frame: At 2 years follow-up
Fitness are assessed by Åstrands test
Fitness
Time frame: At 5 years follow-up
Fitness are assessed by Åstrands test
Pain thresholds
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
Pain thresholds
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
Pain thresholds
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
Knee injury and osteoarthritis outcome score (KOOS)
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).
Knee injury and osteoarthritis outcome score (KOOS)
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).
Knee injury and osteoarthritis outcome score (KOOS)
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).
Knee injury and osteoarthritis outcome score (KOOS)
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).
Knee injury and osteoarthritis outcome score (KOOS)
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).
Knee injury and osteoarthritis outcome score (KOOS)
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).
Pain mannequin
Time frame: At baseline
Patient reported pain distribution
Pain mannequin
Time frame: At 1 year follow-up
Patient reported pain distribution
Pain mannequin
Time frame: At 2 years follow-up
Patient reported pain distribution
Pain mannequin
Time frame: At 3 years follow-up
Patient reported pain distribution
Pain mannequin
Time frame: At 4 years follow-up
Patient reported pain distribution
Pain mannequin
Time frame: At 5 years follow-up
Patient reported pain distribution
Pain intensity
Time frame: At baseline
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Pain intensity
Time frame: At 1 year follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Pain intensity
Time frame: At 2 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Pain intensity
Time frame: At 3 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Pain intensity
Time frame: At 4 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Patient intensity
Time frame: At 5 years follow-up
Patient reported pain intensity by NRS scale 0-10 (best to worst)
Radiographic assessment of the knees
Time frame: At baseline
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the knees
Time frame: At 1 year follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the knees
Time frame: At 2 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the knees
Time frame: At 3 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the knees
Time frame: At 4 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the knees
Time frame: At 5 years follow-up
radiographic assessment of tibiofemoral- and patellofemoral joint in the knee
Radiographic assessment of the hands
Time frame: At 2 years follow-up
Radiographic assessment of the hands.
Radiographic assessment of the hands
Time frame: At 5 years follow-up
Radiographic assessment of the hands.
Mechanical load
Time frame: At inclusion
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Mechanical load
Time frame: At 2 years follow-up
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
Mechanical load
Time frame: At 5 years follow-up
Movement behavior measured with a triaxle accelerometer at work and leisure over 7 days
48 secondary outcomes
Blood samples for biobanking
Time frame: At baseline
Blood samples for biobanking
Time frame: At 1 year follow-up
Blood samples for biobanking
Time frame: At 2 years follow-up
Blood samples for biobanking
Time frame: At 3 years follow-up
Blood samples for biobanking
Time frame: At 4 years follow-up
Blood samples for biobanking
Time frame: At 5 years follow-up
Patient reported physical activity
Time frame: At baseline
Patient reported physical activity
Time frame: At 1 year follow-up
Patient reported physical activity
Time frame: At 2 years follow-up
Patient reported physical activity
Time frame: At 3 years follow-up
Patient reported physical activity
Time frame: At 4 years follow-up
Patient reported physical activity
Time frame: At 5 years follow-up
Patient reported smoking and snuff habits
Time frame: At baseline
Patient reported smoking and snuff habits
Time frame: At 1 years follow-up
Patient reported smoking and snuff habits
Time frame: At 2 years follow-up
Patient reported smoking and snuff habits
Time frame: At 3 years follow-up
Patient reported smoking and snuff habits
Time frame: At 4 years follow-up
Patient reported smoking and snuff habits
Time frame: At 5 years follow-up
Patient reported diets
Time frame: At baseline
Patient reported diets
Time frame: At 1 year follow-up
Patient reported diets
Time frame: At 2 years follow-up
Patient reported diets
Time frame: At 3 years follow-up
Patient reported diets
Time frame: At 4 years follow-up
Patient reported diets
Time frame: At 5 years follow-up
Patient reported alcohol habits
Time frame: At baseline
Patient reported alcohol habits
Time frame: At 1 year follow-up
Patient reported alcohol habits
Time frame: At 2 years follow-up
Patient reported alcohol habits
Time frame: At 3 years follow-up
Patient reported alcohol habits
Time frame: At 4 years follow-up
Patient reported alcohol habits
Time frame: At 5 years follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 1 year follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 2 years follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 3 years follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 4 years follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: At 5 years follow-up
Health literacy
Time frame: At 2 years follow-up
Health literacy
Time frame: At 3 years follow-up
Health literacy
Time frame: At 5 years follow-up
Clinical examination of the knees
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40200207Tornblom 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.
- Derived from this study: PubMed 39578778Brogren 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.
- Derived from this study: PubMed 38458788Tornblom 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.
- Derived from this study: PubMed 37559026Andersson 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.
- Derived from this study: PubMed 36307803Andersson 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.
- Derived from this study: PubMed 35835523Andersson 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.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria LE Andersson, ass.prof. principal investigator
FoU Spenshult
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis Hand, run by FoU Center Spenshult at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (kg/m2) (time frame: At baseline). The study lists 127 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928170, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.