Musculoskeletal DisordersIRMANCT01921764
Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers
A study testing Workplace physical exercise and Home physical exercise in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous studies have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether… Read more about this study
- Who is it for?
- Ages 18 to 67 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Workplace physical exercise and Home physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Jan 2014
- Phase
- Interventional
- 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 67 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthcare worker
- female
- age 18-67
Who cannot join
- life threatening disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous studies have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or in the private sphere at home. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase compliance. On the other hand, physical exercise at the workplace may be costly for the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study investigates the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers.
The main hypothesis is that physical exercise at the workplace for 10 weeks compared with physical exercise at home results in reduced musculoskeletal pain among healthcare workers.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Workplace physical exercise, Home physical exercise
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace physical exerciseBehavioural
Home physical exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Workplace physical exercise | Experimental | Physical exercise (kettlebells, elastic bands, exercise balls) performed at the workplace with coaching Receives: Behavioral: Workplace physical exercise |
| Home physical exercise | Active comparator | Physical exercise performed at home with elastic bands and bodyweight exercises with instruction to follow the exercises at http://www.jobogkrop.dk/Oevelser-til-nakke-og-ryg/Oevelser Receives: Behavioral: Home physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The change in "pain intensity during the last week" from baseline to 10 week follow-up between the workplace- and home-training group. The home-training group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor. Department will be added as a cluster effect.
Measured: change from baseline to week 10
Secondary outcomes (3)
Muscle function
Measured: change from baseline to week 10
Work ability index (WAI)
Measured: change from baseline to week 10
Physical exertion during work
Measured: change from baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921764
- Sponsor's protocol ID
- IRMA08
- Acronym
- IRMA
- Status last verified
- Jan 2014
- First submitted
- 10 Aug 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jakobsen MD, Sundstrup E, Brandt M, Andersen LL. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial. BMC Public Health. 2017 Oct 10;17(1):798. doi: 10.1186/s12889-017-4728-3.
PubMed 29017479Jakobsen MD, Sundstrup E, Brandt M, Jay K, Aagaard P, Andersen LL. Physical exercise at the workplace prevents deterioration of work ability among healthcare workers: cluster randomized controlled trial. BMC Public Health. 2015 Nov 25;15:1174. doi: 10.1186/s12889-015-2448-0.
PubMed 26607232Jakobsen MD, Sundstrup E, Brandt M, Jay K, Aagaard P, Andersen LL. Effect of Workplace- versus Home-Based Physical Exercise on Muscle Response to Sudden Trunk Perturbation among Healthcare Workers: A Cluster Randomized Controlled Trial. Biomed Res Int. 2015;2015:902896. doi: 10.1155/2015/902896. Epub 2015 Oct 25.
PubMed 26583145Jakobsen MD, Sundstrup E, Brandt M, Kristensen AZ, Jay K, Stelter R, Lavendt E, Aagaard P, Andersen LL. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 7;15:119. doi: 10.1186/1471-2474-15-119.
PubMed 24708570
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers
- ClinicalTrials.gov ID
- NCT01921764
- Acronym / sponsor ID
- IRMA / IRMA08
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Aug 2013 (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 prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous studies have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or in the private sphere at home. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase compliance. On the other hand, physical exercise at the workplace may be costly for the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study investigates the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers.
The main hypothesis is that physical exercise at the workplace for 10 weeks compared with physical exercise at home results in reduced musculoskeletal pain among healthcare workers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workplace physical exercise | Experimental | Behavioral: Workplace physical exercisePhysical exercise (kettlebells, elastic bands, exercise balls) performed at the workplace with coaching |
| Home physical exercise | Active comparator | Behavioral: Home physical exercisePhysical exercise performed at home with elastic bands and bodyweight exercises with instruction to follow the exercises at http://www.jobogkrop.dk/Oevelser-til-nakke-og-ryg/Oevelser |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthcare worker
- female
- age 18-67
Key exclusion criteria (2 listed)
- life threatening disease
- pregnancy
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 |
|---|---|---|
| Workplace physical exercise | Behavioural | Workplace physical exercise |
| Home physical exercise | Behavioural | Home physical exercise |
Primary outcome
Pain intensity
Time frame: change from baseline to week 10
The change in "pain intensity during the last week" from baseline to 10 week follow-up between the workplace- and home-training group. The home-training group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor. Department will be added as a cluster effect.
3 secondary outcomes
Muscle function
Time frame: change from baseline to week 10
Work ability index (WAI)
Time frame: change from baseline to week 10
Physical exertion during work
Time frame: change from baseline to week 10
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 28 Jan 2014.
- Derived from this study: PubMed 29017479Jakobsen MD, Sundstrup E, Brandt M, Andersen LL. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial. BMC Public Health. 2017 Oct 10;17(1):798. doi: 10.1186/s12889-017-4728-3.
- Derived from this study: PubMed 26607232Jakobsen MD, Sundstrup E, Brandt M, Jay K, Aagaard P, Andersen LL. Physical exercise at the workplace prevents deterioration of work ability among healthcare workers: cluster randomized controlled trial. BMC Public Health. 2015 Nov 25;15:1174. doi: 10.1186/s12889-015-2448-0.
- Derived from this study: PubMed 26583145Jakobsen MD, Sundstrup E, Brandt M, Jay K, Aagaard P, Andersen LL. Effect of Workplace- versus Home-Based Physical Exercise on Muscle Response to Sudden Trunk Perturbation among Healthcare Workers: A Cluster Randomized Controlled Trial. Biomed Res Int. 2015;2015:902896. doi: 10.1155/2015/902896. Epub 2015 Oct 25.
- Derived from this study: PubMed 24708570Jakobsen MD, Sundstrup E, Brandt M, Kristensen AZ, Jay K, Stelter R, Lavendt E, Aagaard P, Andersen LL. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 7;15:119. doi: 10.1186/1471-2474-15-119.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace physical exercise and Home physical exercise in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, 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 28 Jan 2014. 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?
Pain intensity (time frame: change from baseline to week 10). 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 NCT01921764, which also lists 4 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 28 Jan 2014.