Physical activity to prevent deterioration in cleaners
| ISRCTN | ISRCTN96241850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96241850 |
| Secondary identifying numbers | TKIF2006-018 |
- Submission date
- 04/04/2008
- Registration date
- 30/04/2008
- Last edited
- 06/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Marie Birk Jørgensen
Scientific
Scientific
Lersø Parkallé 105
Copenhagen Ø
2100
Denmark
| Phone | +45 39 16 53 46 |
|---|---|
| mbj@arbejdsmiljoforskning.dk |
Study information
| Study design | Cluster randomised controlled intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Preventing deterioration among cleaners |
| Study acronym | FINALE 4 |
| Study objectives | 1. Physical coordination training reduces shoulder and neck pain in cleaners 2. Physical coordination training is more effective than cognitive behavioural training in reducing pain in the short term (months) 3. Cognitive behavioural training is more effective than physical coordination training in increasing physical activity in the long term (years) |
| Ethics approval(s) | Ethics approval received from the Committees on Biomedical Research Ethics of the Capital Region of Denmark on the 13th May 2008 (ref: H-C-2007-0033). |
| Health condition(s) or problem(s) studied | Shoulder and neck pain |
| Intervention | Participants are randomised in clusters related to their team at the workplace to receive one of the following for one year: 1. Physical coordination training: Three weekly training sessions at the work place of 20 minutes duration is offered to the participants during the first three months of intervention. The training persists of physically hard exercises that demands high activation of stabilising muscles around the trunk and shoulder girdle. The amount of training sessions is slowly reduced during the subsequent three months and during the last six months, there will only be one meeting every month, where the participants are introduced to new interesting types of physical activity. 2. Cognitive behavioural training: Two monthly training sessions at the work place of two hours duration is offered to the participants during the first three months of intervention. The training persists of information and cognitive exercises regarding biological causes of pain, differentiation between pain and injury, and strategies for relaxation. The amount of training sessions is reduced to one every month during three months and then the duration of the sessions is reduced to one hour per session during the last six months. Here the participants' success with training cognitively and behaviourally is evaluated and the participants receive help to proceed. 3. Health check (control): The reference group receives one health check during the whole one year intervention period of one-hour duration. The health check is given in order to give the participants a feeling of output for their participation in the tests and questionnaires. The health check includes pulmonary-function test and fitness test. The results are given to the participants but no instruction is given regarding treatment, unless it is ethically irresponsible. |
| Intervention type | Other |
| Primary outcome measure | 1. Sick leave, obtained through participating companies annual registrations 2. Work ability, measured using the Work Ability Index Questionnaire (developed by the Finnish Institute of Occupational Health) Both primary and secondary outcomes will be measured before the intervention (timepoint 1 [Oct/Nov 2008]), after the first intensive intervention period (timepoint 2 [Jan/Feb 2009]) and after the one-year intervention (timepoint 3 [Oct/Nov 2009]). |
| Secondary outcome measures | 1. Musculoskeletal pain, measured using the Nordic Council of Ministers quiestionnaire on musculoskeletal complaints 2. Physical capacity (strength, coordination), measured as isometric maximal voluntary contraction in four exercises: 2.1. Trunk flexion 2.2. Trunk extension 2.3. Shoulder lift 2.4. Shoulder abduction As a measure of postural sway on a force platform and as a measure of stability in a force steadiness exercise for the shoulder muscles 3. Kinesiophobia Both primary and secondary outcomes will be measured before the intervention (timepoint 1 [Oct/Nov 2008]), after the first intensive intervention period (timepoint 2 [Jan/Feb 2009]) and after the one-year intervention (timepoint 3 [Oct/Nov 2009]). |
| Overall study start date | 01/08/2007 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Cleaners at larger cleaning departments 2. Aged 18 - 65 years, either sex |
| Key exclusion criteria | 1. Angina pectoris 2. Pregnancy 3. Life-threatening diseases |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Lersø Parkallé 105
Copenhagen Ø
2100
Denmark
2100
Denmark
Sponsor information
The Ministry of Culture Committee on Sports Research (Denmark)
Government
Government
H.C. Andersens Boulevard 2
København V
1553
Denmark
| Phone | +45 33 74 55 52 |
|---|---|
| evajen@kumadm.dk | |
| Website | http://www.kumadm.dk/sw69098.asp |
"ROR" |
https://ror.org/04qdzjg14 |
Funders
Funder type
Government
The Ministry of Culture Committee on Sports Research (Denmark) (ref: TKIF2006-018)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/03/2010 | Yes | No | |
| Results article | results | 14/06/2010 | Yes | No | |
| Results article | results | 10/10/2011 | Yes | No | |
| Results article | results | 22/02/2012 | Yes | No |
