Physical activity to prevent deterioration in cleaners

ISRCTN	ISRCTN96241850
DOI	https://doi.org/10.1186/ISRCTN96241850
Protocol serial number	TKIF2006-018
Sponsor	The Ministry of Culture Committee on Sports Research (Denmark)
Funder	The Ministry of Culture Committee on Sports Research (Denmark) (ref: 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

Primary study design	Interventional
Study design	Cluster randomised controlled intervention trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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]).
Key secondary outcome measure(s)	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]).
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/06/2010		Yes	No
Results article	results	10/10/2011		Yes	No
Results article	results	22/02/2012		Yes	No
Protocol article	protocol	09/03/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes