Musculoskeletal DiseasesPhase 1NCT01007669
Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work
A Phase 1 study testing Physical activity and Health check and Health check only in people with Musculoskeletal Diseases, run by Bibi Gram at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Physical activity and Health check and Health check only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Sep 2011
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Constructions workers, working for more than 20 hours pr week, Physical heavy work tasks (in Danish: brolæggere, rørlæggere, mekanikere)
Who cannot join
- Workers with flexible job i.e. for people with a reduced ability to work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Specified Work Site Physical Activity Intervention on Musculoskeletal Disorders Among Employees With Physical Heavy Work
The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.
Read the detailed description
Studies regarding company adjusted intervention have shown positive effects regarding work related neck and shoulder symptoms among workers with monotonous repetitive work. However, limited research is available on physical exercise intervention among workers with physically heavy work. This study introduces a new intervention concept to treat and prevent musculoskeletal disorders including individually and health check based exercise intervention.
The aim of this randomized controlled intervention project is
- Through Health check to outline the extent musculoskeletal disability in workers with heavy work load in relation to physical and metabolic fitness. Includes is also assessment of physical general activity and working conditions.
- To evaluate the effect of individual adjusted exercise programs on muscle strength, aerobic capacity, musculoskeletal disability, pain, work ability and sick absenteeism
- Conditions
- Musculoskeletal Diseases
- Being tested
- Physical activity and Health check, Health check only
- Keywords
- Physical activity
- Medical subject headings
- Musculoskeletal Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and Health checkBehavioural
Strength training, aerobic capacity training.
Health check onlyBehavioural
Health check
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Health check only Receives: Behavioral: Health check only |
| Intervention | Experimental | Physical activity and Health check Receives: Behavioral: Physical activity and Health check |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Measured: 3 months
Aerobic capacity
Measured: 3 months
Secondary outcomes (2)
Questionnaire
Measured: 1 year
Health Check
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bibi Gram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bibi Gram, University of Southern Denmark
- Investigators
- Bibi Gram, M.Sc.,PT, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007669
- Sponsor's protocol ID
- s-20090058
- Status last verified
- Feb 2013
- First submitted
- 3 Nov 2009
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gram B, Westgate K, Karstad K, Holtermann A, Sogaard K, Brage S, Sjogaard G. Occupational and leisure-time physical activity and workload among construction workers - a randomized control study. Int J Occup Environ Health. 2016 Jan;22(1):36-44. doi: 10.1080/10773525.2016.1142724. Epub 2016 Apr 21.
PubMed 27097799Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.
PubMed 20214807
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specified Work Site Physical Activity Intervention on Musculoskeletal Disorders Among Employees With Physical Heavy Work
- ClinicalTrials.gov ID
- NCT01007669
- Acronym / sponsor ID
- s-20090058
- Conditions
- Musculoskeletal Diseases
- Keywords
- Physical activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bibi GramUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- 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 purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.
Detailed description
Studies regarding company adjusted intervention have shown positive effects regarding work related neck and shoulder symptoms among workers with monotonous repetitive work. However, limited research is available on physical exercise intervention among workers with physically heavy work. This study introduces a new intervention concept to treat and prevent musculoskeletal disorders including individually and health check based exercise intervention.
The aim of this randomized controlled intervention project is
- Through Health check to outline the extent musculoskeletal disability in workers with heavy work load in relation to physical and metabolic fitness. Includes is also assessment of physical general activity and working conditions.
- To evaluate the effect of individual adjusted exercise programs on muscle strength, aerobic capacity, musculoskeletal disability, pain, work ability and sick absenteeism
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Behavioral: Health check onlyHealth check only |
| Intervention | Experimental | Behavioral: Physical activity and Health checkPhysical activity and Health check |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Constructions workers, working for more than 20 hours pr week, Physical heavy work tasks (in Danish: brolæggere, rørlæggere, mekanikere)
Key exclusion criteria (1 listed)
- Workers with flexible job i.e. for people with a reduced ability to work
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 |
|---|---|---|
| Physical activity and Health checkStrength training, aerobic capacity training. | Behavioural | Intervention |
| Health check onlyHealth check | Behavioural | Reference |
Primary outcome
muscle strength
Time frame: 3 months
Aerobic capacity
Time frame: 3 months
2 secondary outcomes
Questionnaire
Time frame: 1 year
Health Check
Time frame: 3 months
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 11 Feb 2013.
- Derived from this study: PubMed 27097799Gram B, Westgate K, Karstad K, Holtermann A, Sogaard K, Brage S, Sjogaard G. Occupational and leisure-time physical activity and workload among construction workers - a randomized control study. Int J Occup Environ Health. 2016 Jan;22(1):36-44. doi: 10.1080/10773525.2016.1142724. Epub 2016 Apr 21.
- Derived from this study: PubMed 20214807Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.
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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.
Bibi Gram, M.Sc.,PT principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical activity and Health check and Health check only in people with Musculoskeletal Diseases, run by Bibi Gram 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 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: finished, as of the sponsor's last update on 11 Feb 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
muscle strength (time frame: 3 months). The study lists 2 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 NCT01007669, which also lists 2 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 11 Feb 2013.