Contact information
Type
Scientific
Primary contact
Miss Marie Birk Jørgensen
ORCID ID
Contact details
Lersø Parkallé 105
Copenhagen Ø
2100
Denmark
+45 39 16 53 46
mbj@arbejdsmiljoforskning.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TKIF2006-018
Study information
Scientific title
Preventing deterioration among cleaners
Acronym
FINALE 4
Study hypothesis
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
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).
Study design
Cluster randomised controlled intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/08/2007
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Cleaners at larger cleaning departments
2. Aged 18 - 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Angina pectoris
2. Pregnancy
3. Life-threatening diseases
Recruitment start date
01/08/2007
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Denmark
Trial participating centre
Lersø Parkallé 105
Copenhagen Ø
2100
Denmark
Sponsor information
Organisation
The Ministry of Culture Committee on Sports Research (Denmark)
Sponsor details
H.C. Andersens Boulevard 2
København V
1553
Denmark
+45 33 74 55 52
evajen@kumadm.dk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Ministry of Culture Committee on Sports Research (Denmark) (ref: TKIF2006-018)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20214807
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20546592
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21985226
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22356733
Publication citations
-
Protocol
Holtermann A, Jørgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjøgaard G, Søgaard K, Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE., BMC Public Health, 2010, 10, 120, doi: 10.1186/1471-2458-10-120.
-
Results
Jørgensen MB, Rasmussen CD, Ekner D, Søgaard K, Successful reach and adoption of a workplace health promotion RCT targeting a group of high-risk workers., BMC Med Res Methodol, 2010, 10, 56, doi: 10.1186/1471-2288-10-56.
-
Results
Jørgensen MB, Ektor-Andersen J, Sjøgaard G, Holtermann A, Søgaard K, A randomised controlled trial among cleaners--effects on strength, balance and kinesiophobia., BMC Public Health, 2011, 11, 776, doi: 10.1186/1471-2458-11-776.
-
Results
Jespersen T, Jørgensen MB, Hansen JV, Holtermann A, Søgaard K, The relationship between low back pain and leisure time physical activity in a working population of cleaners--a study with weekly follow-ups for 1 year., BMC Musculoskelet Disord, 2012, 13, 28, doi: 10.1186/1471-2474-13-28.