Work AbilityNCT05811767
The Esbjerg Cohort - A Cross-sectional Study About Work Ability and Musculoskeletal Pain in 55 to 70 Years Old Workers
An observational study of Work Ability and Occupational Health, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
The overall aim of this study is to investigate how work with physical demands affects the physical capacity, work ability, labor market affiliation, pain and self-reported health in the oldest group of workers. Following research questions are to be answered: 1. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Ability, Occupational Health, Physical Capacity
- What is being tested?
- Health Examination
- How many people
- 331 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Nov 2022to 15 Apr 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Citizens between 55 and 70 years old living in the Esbjerg municipality.
Who may be able to join
- Men and women born between 1952 and 1966
- Living in the Esbjerg municipality
- Able to write, read and understand Danish
Who cannot join
- Injuries to arms or legs (e.g arm in plaster, acute trauma on ACL)
- Just had a surgery (e.g an operation in the abdominal region or in the brain)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Hospital South West Jutland, University hospital of Southern Denmark
Esbjerg, 6700
About this study
Official title: Ergonomic Exposure in Relation to Physical Capacity and Its Effect on Work Ability and Musculoskeletal Pain in the Oldest Group of Workers - The Esbjerg Cohort
The overall aim of this study is to investigate how work with physical demands affects the physical capacity, work ability, labor market affiliation, pain and self-reported health in the oldest group of workers.
Following research questions are to be answered:
- How high physical work demands affects muscle strength in 55-70-year-old workers and how obesity in combination with high physical work exposure influences muscle strength, work ability, cardiac function, and self-reported health?
- Which parameters are important for work ability and how does the exposure of high physical workload affect the work ability over time in 55-70-year-old workers?
- By exploring the underlying mechanism of pain among 55+ year old workers, how is pain associated with work ability, BMI and physical capacity?
Read the detailed description
This study is a population-based cross-sectional study conducted in the municipality Esbjerg, Denmark. This study wants to investigate how ergonomic exposure in relation to physical capacity has an effect on work ability and musculoskeletal pain in workers between 55 and 70 years old. This Ph.D. is a clinical study including physical tests, questionnaires, and long-term evaluation of work ability. The study population consists of 336 citizens divided into 12 groups stratified for gender, age (< 60 years, 60-64 years and above 64 years) and occupational group (white-collar or blue-collar worker).
The study population will be recruited to uncover the physical workload among citizens 55+ years and compare the physical work demands to their health status, pain and physical capacity. The intention is to provide knowledge of the consequences of high physical workload on the musculoskeletal system in the oldest group of workers. This knowledge is necessary for better treatment and counseling to the oldest group of workers and for improved guidelines on how to optimize the balance between the physical work demands and the capacity of the workers.
- Being tested
- Health Examination
- Keywords
- Work ability, Senior workers, Physical capacity, Musculoskeletal pain
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health ExaminationOther
The study is a cross-sectional study and therefore there is no intervention. The study consist only of tests, questionnaires and a blood test. See the elements under outcomes measures.
| Study group | Role | What they receive |
|---|---|---|
| The Esbjerg Cohort | This is a cross-sectional study and therefore there is no intervention to describe. The study consist only of tests, questionnaires and a blood test. See the elements under outcomes measures. Receives: Other: Health Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Ability
Measured with Work Ability Index (WAI), which is a questionnaire, measuring seven items to assess the workers work ability
Measured: Baseline
Secondary outcomes (23)
Height
Measured in centimeters
Measured: Baseline
Weight
Measured in kilograms
Measured: Baseline
Body Mass Index (BMI)
Calculated by kg/m^2
Measured: Baseline
Waist-to-hip ratio
Measured in centimeters between the hip and the waist
Measured: Baseline
Blood pressure
Both diastolic and systolic
Measured: Baseline
Pressure Pain Threshold
A part of the quantitative sensory testing battery. Measured with an algometer three times on thenar eminence at the non-dominant hand and at tibialis anterior on the non-dominant leg
Measured: Baseline
Warm and cold detection threshold
A part of the quantitative sensory testing battery. Measured with a TSA 2001-II machine on thenar eminence at the non-dominant hand. The temperature rises and falls three times each with 1°C/s. The participant press a button, when they feel a change in temperature.
Measured: Baseline
Heat and cold pain threshold
A part of the quantitative sensory testing battery. Measured with a TSA 2001-II machine on thenar eminence at the non-dominant hand. The temperature rises falls three times each with 1°C/s. The participant press a button, when they detects pain.
Measured: Baseline
Temporal summation
A part of the quantitative sensory testing battery. Measured with a TSA 2001-II machine. Ten brief repetitive heat pulses at thenar eminence on both hands. There the participant rates the second pain approximately one second after each stimulus.
Measured: Baseline
Conditioned pain modulation
A part of the quantitative sensory testing battery. Two separate stimuli were used. A test stimulus and a conditioning stimulus. The test stimulus consisted of pressure pain threshold measurements as described above. The test stimulus was performed on the non-dominant hand at the thenar eminence and tibialis anterior before and immediately after the conditioning stimulus, with one minute between the two test sides. The conditioning stimulus was a cold pressor test which consisted of cold water (10°C) immersion of the hand on the dominant side down to the wrist for a duration of two minutes.
Measured: Baseline
Physical Activity
Measured with The international Physical Activity Questionnaire (IPAQ), which is a 27-item self-reported questionnaire about physical activity for the last seven days at work and in spare time.
Measured: Baseline
Musculoskeletal pain
Measured with Nordic Musculoskeletal Questionnaire (NMQ). NMQ consist of a generally questionnaire to asses musculoskeletal disorders in nine anatomical region (ex. Shoulder, low back and knee). In addition, NMQ contains special questionnaires for low back, neck and shoulder symptoms to probe these areas more deeply. In this questionnaire, there have been an extension in the special questionnaires to all nine anatomical regions.
Measured: Baseline
Additionally questions about ergonomic and pain
In addition to the standardized questionnaires described above, an extra questionnaire with further questions about the participant's ergonomics in their work and more generally about their pain on a scale from zero to ten.
Measured: Baseline
30-seconds sit to stand test
Used to test the strength and endurance in the legs. Its measures how many times the participant can get up from a chair in 30 seconds.
Measured: Baseline
Balance test
Performed with a one-leg balance test. It measure how low the participant can stand on one leg with the arms on the waist.
Measured: Baseline
Stair climb test
Measures functional strength, balance and agility. The participant must climb up and down a flight of stairs as quickly as possible.
Measured: Baseline
Maximal aerobic capacity (VO2 max)
Measured with a sub maximal treadmill exercise test, known as Astrand 6 minute cycle test
Measured: Baseline
Isokinetic muscle strength in the shoulder
Measured with a Biodex System 4 dynamometer. The dominant shoulder is tested. The participant makes an abduction and adduction as fast and powerful they can. The test is performed three times with 15 seconds rest between the tests.
Measured: Baseline
Isometric muscle strength in the shoulder
Measured with a Biodex System 4 dynamometer. An isometric contraction in abduction in the dominant shoulder. The participant keeps the tension in 3-5 seconds with 40 seconds break between each test.
Measured: Baseline
Isokinetic muscle strength in the knee
Measured with a Biodex System 4 dynamometer. The non-dominant knee is tested. The participant makes an extension and flexion as fast and powerful they can. The test is performed three times with 15 seconds rest between the tests.
Measured: Baseline
Isometric muscle strength in the knee
Measured with a Biodex System 4 dynamometer. An isometric contraction in extension in the non-dominant knee. The participant keeps the tension in 3-5 seconds with 40 seconds break between each test.
Measured: Baseline
Handgrip strength
Performed with a JAMAR hand dynamometer. The participant press the dominant hand as hard as they can for three to five seconds. The test is performed three times with 15 seconds break between each test.
Measured: Baseline
Psychosocial work environment
Measured with the Danish Psychosocial Work Environment Questionnaire (DPQ). DPQ is a questionnaire used to evaluate the physical work environment (11). It contains 38 themes regarding to physical work environment within five overall dimensions.
Measured: Once after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start14 Nov 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work AbilityStudies 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
- Cross-sectional
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Ejstrup, MSc, Principal investigator, The Hospital South West Jutland, University hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811767
- Sponsor's protocol ID
- esbjerg_cohort
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is under current Danish law not feasible.
Publications
Ejstrup S, Nygaard NB, Thomsen GF, Iversen IB, Christiansen DH, Gram B. Decline in Work Ability over Time and Its Association with Physical Performance Among Senior Workers: A Prospective Cohort Study. Int J Environ Res Public Health. 2026 Jun 26;23(7):842. doi: 10.3390/ijerph23070842.
PubMed 42512148
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Exposure in Relation to Physical Capacity and Its Effect on Work Ability and Musculoskeletal Pain in the Oldest Group of Workers - The Esbjerg Cohort
- ClinicalTrials.gov ID
- NCT05811767
- Acronym / sponsor ID
- esbjerg_cohort
- Keywords
- Work ability, Senior workers, Physical capacity, Musculoskeletal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 13 Apr 2023 (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.
The overall aim of this study is to investigate how work with physical demands affects the physical capacity, work ability, labor market affiliation, pain and self-reported health in the oldest group of workers.
Following research questions are to be answered:
- How high physical work demands affects muscle strength in 55-70-year-old workers and how obesity in combination with high physical work exposure influences muscle strength, work ability, cardiac function, and self-reported health?
- Which parameters are important for work ability and how does the exposure of high physical workload affect the work ability over time in 55-70-year-old workers?
- By exploring the underlying mechanism of pain among 55+ year old workers, how is pain associated with work ability, BMI and physical capacity?
Detailed description
This study is a population-based cross-sectional study conducted in the municipality Esbjerg, Denmark. This study wants to investigate how ergonomic exposure in relation to physical capacity has an effect on work ability and musculoskeletal pain in workers between 55 and 70 years old. This Ph.D. is a clinical study including physical tests, questionnaires, and long-term evaluation of work ability. The study population consists of 336 citizens divided into 12 groups stratified for gender, age (< 60 years, 60-64 years and above 64 years) and occupational group (white-collar or blue-collar worker).
The study population will be recruited to uncover the physical workload among citizens 55+ years and compare the physical work demands to their health status, pain and physical capacity. The intention is to provide knowledge of the consequences of high physical workload on the musculoskeletal system in the oldest group of workers. This knowledge is necessary for better treatment and counseling to the oldest group of workers and for improved guidelines on how to optimize the balance between the physical work demands and the capacity of the workers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Esbjerg Cohort | – | Other: Health ExaminationThis is a cross-sectional study and therefore there is no intervention to describe. The study consist only of tests, questionnaires and a blood test. See the elements under outcomes measures. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Citizens between 55 and 70 years old living in the Esbjerg municipality.
Key inclusion criteria (3 listed)
- Men and women born between 1952 and 1966
- Living in the Esbjerg municipality
- Able to write, read and understand Danish
Key exclusion criteria (2 listed)
- Injuries to arms or legs (e.g arm in plaster, acute trauma on ACL)
- Just had a surgery (e.g an operation in the abdominal region or in the brain)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health ExaminationThe study is a cross-sectional study and therefore there is no intervention. The study consist only of tests, questionnaires and a blood test. See the elements under outcomes measures. | Other | The Esbjerg Cohort |
Primary outcome
Work Ability
Time frame: Baseline
Measured with Work Ability Index (WAI), which is a questionnaire, measuring seven items to assess the workers work ability
23 secondary outcomes
Height
Time frame: Baseline
Weight
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Waist-to-hip ratio
Time frame: Baseline
Blood pressure
Time frame: Baseline
Pressure Pain Threshold
Time frame: Baseline
Warm and cold detection threshold
Time frame: Baseline
Heat and cold pain threshold
Time frame: Baseline
Temporal summation
Time frame: Baseline
Conditioned pain modulation
Time frame: Baseline
Physical Activity
Time frame: Baseline
Musculoskeletal pain
Time frame: Baseline
Additionally questions about ergonomic and pain
Time frame: Baseline
30-seconds sit to stand test
Time frame: Baseline
Balance test
Time frame: Baseline
Stair climb test
Time frame: Baseline
Maximal aerobic capacity (VO2 max)
Time frame: Baseline
Isokinetic muscle strength in the shoulder
Time frame: Baseline
Isometric muscle strength in the shoulder
Time frame: Baseline
Isokinetic muscle strength in the knee
Time frame: Baseline
Isometric muscle strength in the knee
Time frame: Baseline
Handgrip strength
Time frame: Baseline
Psychosocial work environment
Time frame: Once after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 42512148Ejstrup S, Nygaard NB, Thomsen GF, Iversen IB, Christiansen DH, Gram B. Decline in Work Ability over Time and Its Association with Physical Performance Among Senior Workers: A Prospective Cohort Study. Int J Environ Res Public Health. 2026 Jun 26;23(7):842. doi: 10.3390/ijerph23070842.
- Individual participant dataSharing planned: No. Sharing of IPD is under current Danish law not feasible.
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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.
Simone Ejstrup, MSc principal investigator
The Hospital South West Jutland, University hospital of Southern Denmark
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 Work Ability and Occupational Health, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Apr 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Work Ability (time frame: Baseline). 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 NCT05811767, which also lists 1 linked publication.
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 23 Apr 2024.