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ISRCTN
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ISRCTN96241850
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ClinicalTrials.gov identifier
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Public title
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Physical activity to prevent deterioration in cleaners
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Scientific title
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Preventing deterioration among cleaners
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Acronym
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FINALE 4
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Serial number at source
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TKIF2006-018
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Study hypothesis
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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)
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Ethics approval
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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).
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Study design
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Cluster randomised controlled intervention trial
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Shoulder and neck pain
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Participants - inclusion criteria
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1. Cleaners at larger cleaning departments
2. Aged 18 - 65 years, either sex
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Participants - exclusion criteria
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1. Angina pectoris
2. Pregnancy
3. Life-threatening diseases
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Anticipated start date
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01/08/2007
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Anticipated end date
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01/12/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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400
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Interventions
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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.
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Primary outcome measure(s)
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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]).
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Secondary outcome measure(s)
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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]).
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Sources of funding
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The Ministry of Culture Committee on Sports Research (Denmark) (ref: TKIF2006-018)
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Trial website
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Publications
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Contact name
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Miss
Marie Birk
Jørgensen
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Address
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Lersø Parkallé 105
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City/town
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Copenhagen Ø
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Zip/Postcode
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2100
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Country
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Denmark
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Tel
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+45 39 16 53 46
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Email
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mbj@arbejdsmiljoforskning.dk
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Sponsor
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The Ministry of Culture Committee on Sports Research (Denmark)
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Address
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H.C. Andersens Boulevard 2
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City/town
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København V
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Zip/Postcode
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1553
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Country
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Denmark
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Tel
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+45 33 74 55 52
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Email
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evajen@kumadm.dk
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Sponsor website:
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http://www.kumadm.dk/sw69098.asp
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Date applied
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04/04/2008
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Last edited
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22/05/2008
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Date ISRCTN assigned
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30/04/2008
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