Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000087257
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
19/01/2018
Date last updated
19/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of the Physiotherapy intervention of an occupational health program on the work-related musculoskeletal disorders (WMSDs) and Psychosocial Risks
Scientific title
Physiotherapy intervention on work-related musculoskeletal disorders (WMSDs) and Psychosocial Risks
Secondary ID [1] 292087 0
None
Universal Trial Number (UTN)
U1111-1197-1123
Trial acronym
PofMIandPRinFCofD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial Risks 303507 0
Musculoskeletal Injuries 303508 0
Condition category
Condition code
Musculoskeletal 302923 302923 0 0
Other muscular and skeletal disorders
Mental Health 302924 302924 0 0
Other mental health disorders
Injuries and Accidents 303356 303356 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is characterized by being an experimental descriptive study, since it is intended to analyze the effect of the implementation of training sessions and health education program.
The program lasts for 12 weeks, with 4 sessions per week: 3 times the exercise component and a health education session for 20 to 30 minutes following the ACSM guidelines that indicate warm-up, strength, neuromotor, aerobic training and flexibility of session with relaxation at the end of the exercises.
The exercise program will include aerobic (walking, squatting, step), strength (upper limbs and lower limbs exercises using elastics and barbells) and flexibility (stretching and balance training), progression in physical training according to the effort analysis of each participant according to the Borg scale with target of 8 on a 10 point Borg scale, with increasing intensity after effort reduction. The intensity of the exercise will be the high intensity interval training (75-80% of VO2max) 5x 30 seconds interspersed with 1 minute of low intensity exercise (50-60% of VO2max) during 10 a 15 minutes.
The topics of the health education session will be ergonomic risks at work, musculoskeletal disorders and how to help prevent, and about psychosocial risks and how they influence musculoskeletal disorders, self-management strategies with postural and psychosocial risks.
The physiotherapist will present them, will be responsible for applying the exercises in small groups of participants and evaluations in the pre-test and post-test mode.
The implementation of the program will be in the workplace, before starting working hours.
Intervention code [1] 298230 0
Prevention
Intervention code [2] 298643 0
Treatment: Other
Comparator / control treatment
Maintaning the same work habits and answer the questionaire at baseline and after 3 month.
Control group
Active

Outcomes
Primary outcome [1] 302312 0
Analysis a musculoskeletal pain assessment in work age using questionnaire according to Nordic musculoskeletal questionnaire (Mesquita, Ribeiro and Moreira, 2010)
Timepoint [1] 302312 0
At baseline, after 1 month, after 2 month and after 3 months
Primary outcome [2] 302313 0
Analysis a psychosocial risk using questionnaire according to Copenhagen Psychosocial Questionnair [COPSOQ II] according Kristensen (2005) in order to evaluating the concept of "stress at work", is based on the model of demand and control and tries to explain stress as a consequence of the high demands at work and low social support.
Timepoint [2] 302313 0
At baseline, after 1 month, after 2 month and after 3 months
Primary outcome [3] 303020 0
Analysis a physical risks and musculoskeletal symptoms in work age using World Health Organization Disability Assessment Schedule [WHODAS 2.0] (Ustun, Kostanjsek, Chatterji and Rehm, 2015)
Timepoint [3] 303020 0
At baseline, after 1 month, after 2 month and after 3 months
Secondary outcome [1] 335445 0
Correlation of work psychosocial risks (assessed using the Copenhagen Psychosocial Questionnair) with the development of work-related musculoskeletal injuries (assessed using a questionnaire designed for this study).
Timepoint [1] 335445 0
12 weeks post commencement of intervention program

Eligibility
Key inclusion criteria
i] age between 18 and 65 years; ii) understand the objectives of the study and agree to participate voluntarily; iii) be employees of the company's staff; iv] worker be able to work or are under medical treatment for any musculoskeletal disorders.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) Presence of pathology a known health condition of pathology enable exercise; ii) not being able to read and / or write; iii) being pregnant; iv) to have dementia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For this purpose, SPSS, 20.0 version was used in order to treat all the statistical data, for normality verification Kolmogorov-Smirnov test was applied before a descriptive analysis. This last, was calculated based upon standard methods. In order to analyze any characteristically difference between both groups, the t test was applied. In order to find variable relations Pearson’s correlate coefficient (r) was applied. The statistically level of significance was establish in p = 0.05.
Training effects in these measures were determined by using an ANOVA to analyze differences between pretraining and posttraining score. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
8/04/2016
Date of last data collection
Anticipated
Actual
15/07/2016
Sample size
Target
82
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 8939 0
Portugal
State/province [1] 8939 0
Viseu

Funding & Sponsors
Funding source category [1] 296618 0
University
Name [1] 296618 0
Piaget Institute of Viseu
Country [1] 296618 0
Portugal
Primary sponsor type
University
Name
Piaget Institute of Viseu
Address
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country
Portugal
Secondary sponsor category [1] 295578 0
None
Name [1] 295578 0
none
Address [1] 295578 0
none
Country [1] 295578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297850 0
ethical comity of Piaget Institute
Ethics committee address [1] 297850 0
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Ethics committee country [1] 297850 0
Portugal
Date submitted for ethics approval [1] 297850 0
05/02/2016
Approval date [1] 297850 0
25/02/2016
Ethics approval number [1] 297850 0

Summary
Brief summary
In recent decades, emphasis has been placed on the nature of work change and on new forms of risk that may negatively affect the health and safety of the worker. These changes led the emergence of new occupational hazards for the worker, as is the case of psychosocial risks and work-related musculoskeletal disorders (WMSD´s). Objective: i) Analysis and correlation of a musculoskeletal pain assessment and the psychosocial risks in work age and; ii) Check if an Occupational health program (with labor exercises and health education) can mean positive changes in the perception of WMSD´s and psychosocial risks according to ecological and environmental approach.. Methods: The sample of this study was made by seventy eight workers. Were used as instruments for data gathering , a sociodemographic questionnaire fill, the World Health Organization Disability Assessment Schedule [WHODAS 2.0] and Nordic musculoskeletal injuries was used to assess the physical risks and Copenhagen Psychosocial Questionnair [COPSOQ II] to assess the psichosocial risks. A program was designed with 48 sessions in 12 weeks, with frequency of four times per week during the 12 weeks, with application of labor exercises training and a comparison was made between the pre-test and the post-test. Results: The results obtained allowed to identify the physical consequences of exposure to psychosocial work risk factors and, after the implementation of the established health program workers presented improvements in several outcomes. Conclusion: That the labor exercises training and the occupational health program are beneficial for the implementation in the work context. In this way, it is possible for Physiotherapy professional to plan its intervention, in an occupational health context, in a more effective and preventive manner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75258 0
A/Prof Sandra Gagulic
Address 75258 0
Piaget Institute of Viseu
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75258 0
Portugal
Phone 75258 0
+351232910100
Fax 75258 0
+351232910189
Email 75258 0
cefisioterapia@viseu.ipiaget.pt
Contact person for public queries
Name 75259 0
Gustavo Desouzart
Address 75259 0
Piaget Institute of Viseu
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75259 0
Portugal
Phone 75259 0
+351 232 910 100
Fax 75259 0
+351232910189
Email 75259 0
gustavo.desouzart@viseu.ipiaget.pt
Contact person for scientific queries
Name 75260 0
Gustavo Desouzart
Address 75260 0
Piaget Institute of Viseu
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75260 0
Portugal
Phone 75260 0
+351 232 910 100
Fax 75260 0
Email 75260 0
gustavo.desouzart@viseu.ipiaget.pt

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