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

Lersø Parkallé 105
Copenhagen Ø
2100
Denmark

Phone +45 39 16 53 46
Email mbj@arbejdsmiljoforskning.dk

Study information

Study designCluster randomised controlled intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePreventing deterioration among cleaners
Study acronymFINALE 4
Study objectives1. 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) studiedShoulder and neck pain
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/08/2007
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants400
Key inclusion criteria1. Cleaners at larger cleaning departments
2. Aged 18 - 65 years, either sex
Key exclusion criteria1. Angina pectoris
2. Pregnancy
3. Life-threatening diseases
Date of first enrolment01/08/2007
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Denmark

Study participating centre

Lersø Parkallé 105
Copenhagen Ø
2100
Denmark

Sponsor information

The Ministry of Culture Committee on Sports Research (Denmark)
Government

H.C. Andersens Boulevard 2
København V
1553
Denmark

Phone +45 33 74 55 52
Email evajen@kumadm.dk
Website http://www.kumadm.dk/sw69098.asp
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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