PainPhase 1/2NCT01543984
Efficacy of "Tailored Physical Activity" in Health Care Workers
A Phase 1/2 study testing Tailored Physical Activity and Health Counselling in people with Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days. The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tailored Physical Activity and Health Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Apr 2014
- Phase
- Phase 1/2
- 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
- Health care workers in municipality of Sønderborg that have experienced musculoskeletal pain related to the spine or upper body.
Who cannot join
- Medically safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of "Tailored Physical Activity" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body
The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days.
The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.
Read the detailed description
Health care workers have high prevalence of musculoskeletal pain. Pain in the back and neck and other musculoskeletal disorders are the leading cause for long-term sick leave.
This study test the effect of "Tailored Physical Activity" on self-reported days on sick leave and parameters regarding pain, function and quality of life respectively on the body function and participation level of health care workers which have experienced musculoskeletal pain related to the back or upper body.
A minimum of 44 health care workers in DK-Sønderborg Municipality will be randomized for "Tailored Physical Activity" or a reference group.
Primary endpoint is 3 months and 12 months follow-up.
- Conditions
- Pain
- Being tested
- Tailored Physical Activity, Health Counselling
- Keywords
- health care workers, tailored physical activity, prevention, spine, upper body, pain related to Spine or Upper body
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Physical ActivityOther
Tailored Physical Activity (3*50 min/week in 10 weeks)
Health CounsellingBehavioural
Health guidance (1,5h)
| Study group | Role | What they receive |
|---|---|---|
| Tailored Physical Activity | Experimental | Health guidance (1,5h) and "Tailored Physical Activity" (3*50 min/week in 10 weeks) Receives: Other: Tailored Physical Activity |
| Reference group | Other | Health Counselling (1,5h) Receives: Behavioral: Health Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported number of sick-days
"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months" ((0 days, 1-7 days, 8-30 days, 30 days).
Measured: 3 months
Secondary outcomes (9)
Aerobic capacity
Measured: 3 months
Hand-grip strength
Measured: 3 months
Body weight, waist circumference, hip circumference
Measured: 3 months
Questionnaire
Measured: 3 months
Self-reported number of sick-days
"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months" ((0 days, 1-7 days, 8-30 days, 30 days).
Measured: 12 months follow-up
Aerobic capacity
Measured: 12 months follow-up
Hand-grip strength
Measured: 12- months follow-up
Body weight, waist circumference, hip circumference
Measured: 12 months follow-up
Questionnaire
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionApr 2014
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 PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Municipality of Sønderborg
- Responsible party
- Principal investigator, Lotte Nygaard Andersen, University of Southern Denmark
- Investigators
- Lotte Nygaard Andersen, cand.scient, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543984
- Sponsor's protocol ID
- 95-154-32028T
- Status last verified
- Apr 2014
- First submitted
- 27 Feb 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial. Man Ther. 2015 Oct;20(5):666-71. doi: 10.1016/j.math.2015.04.017. Epub 2015 May 2.
PubMed 25983237Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' in reducing sickness absence among health care workers: design of a randomised controlled trial. BMC Public Health. 2013 Oct 2;13:917. doi: 10.1186/1471-2458-13-917.
PubMed 24088419
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "Tailored Physical Activity" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body
- ClinicalTrials.gov ID
- NCT01543984
- Acronym / sponsor ID
- 95-154-32028T
- Conditions
- Pain
- Keywords
- health care workers, tailored physical activity, prevention, spine, upper body, pain related to Spine or Upper body
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Municipality of Sønderborg
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Mar 2012 (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 test the effect of "Tailored Physical Activity" on the number of sick-days.
The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.
Detailed description
Health care workers have high prevalence of musculoskeletal pain. Pain in the back and neck and other musculoskeletal disorders are the leading cause for long-term sick leave.
This study test the effect of "Tailored Physical Activity" on self-reported days on sick leave and parameters regarding pain, function and quality of life respectively on the body function and participation level of health care workers which have experienced musculoskeletal pain related to the back or upper body.
A minimum of 44 health care workers in DK-Sønderborg Municipality will be randomized for "Tailored Physical Activity" or a reference group.
Primary endpoint is 3 months and 12 months follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Physical Activity | Experimental | Other: Tailored Physical ActivityHealth guidance (1,5h) and "Tailored Physical Activity" (3*50 min/week in 10 weeks) |
| Reference group | Other | Behavioral: Health CounsellingHealth Counselling (1,5h) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health care workers in municipality of Sønderborg that have experienced musculoskeletal pain related to the spine or upper body.
Key exclusion criteria (1 listed)
- Medically safety.
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 |
|---|---|---|
| Tailored Physical ActivityTailored Physical Activity (3*50 min/week in 10 weeks) | Other | Tailored Physical Activity |
| Health CounsellingHealth guidance (1,5h) | Behavioural | Reference group |
Primary outcome
Self-reported number of sick-days
Time frame: 3 months
"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months" ((0 days, 1-7 days, 8-30 days, 30 days).
9 secondary outcomes
Aerobic capacity
Time frame: 3 months
Hand-grip strength
Time frame: 3 months
Body weight, waist circumference, hip circumference
Time frame: 3 months
Questionnaire
Time frame: 3 months
Self-reported number of sick-days
Time frame: 12 months follow-up
Aerobic capacity
Time frame: 12 months follow-up
Hand-grip strength
Time frame: 12- months follow-up
Body weight, waist circumference, hip circumference
Time frame: 12 months follow-up
Questionnaire
Time frame: 12 months follow-up
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 20 Nov 2015.
- Derived from this study: PubMed 25983237Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial. Man Ther. 2015 Oct;20(5):666-71. doi: 10.1016/j.math.2015.04.017. Epub 2015 May 2.
- Derived from this study: PubMed 24088419Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' in reducing sickness absence among health care workers: design of a randomised controlled trial. BMC Public Health. 2013 Oct 2;13:917. doi: 10.1186/1471-2458-13-917.
- University of Southern DenmarkLink provided by the sponsor.
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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.
Lotte Nygaard Andersen, cand.scient 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 1/2 study testing Tailored Physical Activity and Health Counselling in people with Pain, run by University 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 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 20 Nov 2015. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Self-reported number of sick-days (time frame: 3 months). 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 NCT01543984, 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 20 Nov 2015.