Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001018202
Ethics application status
Approved
Date submitted
14/11/2017
Date registered
18/06/2018
Date last updated
18/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a health, safety and well-being programme (MovErgo) in work musculoskeletal disorders
Scientific title
Efficacy of a health, safety and well-being programme (MovErgo) in pain perception among employees of industrial workers
Secondary ID [1] 293342 0
Nil known
Universal Trial Number (UTN)
U1111-1204-9661
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Disorders (1s level)
 305437 0
Mental Health 305438 0
low back pain 305439 0
Condition category
Condition code
Musculoskeletal 304715 304715 0 0
Other muscular and skeletal disorders
Mental Health 304716 304716 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized controlled study with one group undergoing health, safety and well being program (n=40) and other group without exercise training (standard care: job rotation (change task avoid repetitive movements that induce pain ) (n=40) will be conducted. The health, safety and well being program will included exercise training frequency (3*week) and psychoeducation (1*week) during 12 weeks. Exercise training will have duration of 10 min on at the beginning of the work shift and will be conducted by 1 investigator of the team (4 groups with 10 participants). Psychoeducation sessions will have duration of 20-30 minutes and will be conducted by 1 investigator of the team. Each group of intervention will have 10 participants.Exercise training: high intensive interval training (3 minutes cool down: whole body exercises (running straight in same place; high knees running in same place; running quick; running forwards and backwards short distance) 3 minutes exercise (15 sets/1 min 6 rating of perceived in Borg scale; 15 sets/1 min 4 rating of perceived in Borg scale; 15 sets/1 min 6 rating of perceived in Borg scale (squats, standing criss cross, standing crunches, core strength: knee to elbows, side to side chops, cross chops, high knees, twist jumps, side leg raises); 3 min cool down- stretching exercises: (hip flexors stretching; quadricipete stretching; calf stretching; standing forward bend; shoulders stretching (chin retraction; cow face pose; roll shoulders ). Psychoeducation sessions: job coaching; behaviour changes in task performing (3 sessions); benefits of physical activity (3 sessions); empowerment in pain managing (3 sessions);; stress managing strategies (3 sessions). Adherence of intervention will be assessed by direct observation and every 2 weeks with self reported questionnaire (how is your physical condition after star with exercise training, exercise training are important to your work condition; how much times during the week make the exercises).
Intervention code [1] 299611 0
Prevention
Intervention code [2] 299612 0
Rehabilitation
Intervention code [3] 299613 0
Behaviour
Comparator / control treatment
Standard care (job rotation) is treated as a control
Control group
Active

Outcomes
Primary outcome [1] 303942 0
pain perception in shoulder and low back.
Instruments algometry
Timepoint [1] 303942 0
Baseline; Immediately post intervention and 12 weeks after intervention
Primary outcome [2] 303943 0
Outcome: Strengh in quadriceps muscle; anterior deltoid and hand grip
Instrument: Hand held dynamometer in quadriceps, anterior deltoid and jagger dynamometer in hand grip
Timepoint [2] 303943 0
Baseline; Immediately post intervention and 12 weeks after intervention
Primary outcome [3] 303944 0
flexibility in hamstrings and low back with sit and reach
Timepoint [3] 303944 0
Baseline; Immediately post intervention and 12 weeks after intervention
Secondary outcome [1] 340521 0
Outcome: psychosocial risks
Instrument: Copenhagen Psychosocial Questionnaire (COPSOQ)
Timepoint [1] 340521 0
Baseline and Immediately post intervention
Secondary outcome [2] 340522 0
cardiorespiratory fitness with 6-minute walk test
Timepoint [2] 340522 0
Baseline and Immediately post intervention

Eligibility
Key inclusion criteria
inclusion criteria: 18 and 65 years of age, not having any cognitive commitment, being already employed in the company's staff,
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
deaf; having an oncological disease, being pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Type of endpoint/s
Statistical methods / analysis
Descriptive and inferential statistics will be used

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/09/2018
Actual
Sample size
Target
80
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 9356 0
Portugal
State/province [1] 9356 0

Funding & Sponsors
Funding source category [1] 297964 0
University
Name [1] 297964 0
Instituto Piaget Research in Education and Community Intervention (RECI)
Country [1] 297964 0
Portugal
Primary sponsor type
University
Name
Instituto Piaget Research in Education and Community Intervention (RECI)
Address
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country
Portugal
Secondary sponsor category [1] 297028 0
None
Name [1] 297028 0
Address [1] 297028 0
Country [1] 297028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299006 0
Comissão ética Instituto Piaget
Ethics committee address [1] 299006 0
Av. João Paulo II - Lote 2º, 1990-157 Lisboa
Ethics committee country [1] 299006 0
Portugal
Date submitted for ethics approval [1] 299006 0
02/04/2018
Approval date [1] 299006 0
20/04/2018
Ethics approval number [1] 299006 0

Summary
Brief summary
This study aim to assess efficacy of implementation of a combined exercise and educational program in pain perception of industrial workers.
The pertinence of this work is the need to define a specific and effective health and well being program in the reduction and prevention of the high prevalence of musculoskeletal injuries in occupational context in the automobile industry, optimizing the functionality and physical condition of the individual, which is currently a major public health challenge for an aging society.
The proposed program has a total duration of 12 weeks, consisting of sessions with a 4 weekly frequency with duration of 10 minutes at the beginning of each work shift.
Physical exercise sessions (3 times week) and psychoeducation sessions (1 time week)
Prior to the implementation of the program, individual will be evaluated through multiple tests.
This is an interventional study with control group.
Prior to the implementation of the program, all individuals will be evaluated through multiple tests, such as algometry, flexibility test, strength (1RM) and cardio respiratory capacity with 6 min walking test. Data about Psychosocial risks and sociodemographic condition will be evaluated with questionnaire.
The organization of each data collection session should ensure that the proposed measures are all implemented in a single session and in order to minimize as little as possible the collection will be done by an external element to the research.
All instructions prior to the start of the program should be ensured, with respect to the detailed information to all participants and sectors involved, about the organization of the program, objective and activities, explaining carefully all the procedures to be performed to the workers.
In order to ensure the ethics of the procedures, an awareness-raising action will be carried out on the participants of the study, to explain objectives and methodology of the project, being careful not to induce individuals, so that the expected results are not biased.
Each participant will also be given a statement of informed consent in accordance with the recommendations of Helsinki, making explicit the possibility of abandoning the study at any time without any kind of consequence. Also the confidentiality of the identity and personal and clinical data of the subjects will be guaranteed.
The informed consent statement uses clear and accessible language, not resorting to technical terminology difficult to understand for the person signing the Term of Consent. The primary purpose of this process was to obtain the free and properly informed manifestation of the individual who is being invited to participate in the research project and was not seen as a mere legal or bureaucratic formality to be fulfilled, safeguarding any type of coercion in the process of recruiting volunteers
Trial website
Trial related presentations / publications
Public notes
The study was submitted to ethics committee in 2017, but because of changes of ethics commission, new documents were asked and delay the process.
The study must start before of ethical approval because of pressure of company in order implement solutions to workers complaints, due to musculoskeletal disorders.

Contacts
Principal investigator
Name 78974 0
A/Prof Sandra Gagulic
Address 78974 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 78974 0
Portugal
Phone 78974 0
+351 232 910 100
Fax 78974 0
Email 78974 0
[email protected]
Contact person for public queries
Name 78975 0
Sandra Gagulic
Address 78975 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 78975 0
Portugal
Phone 78975 0
+351 232 910 107
Fax 78975 0
Email 78975 0
[email protected]
Contact person for scientific queries
Name 78976 0
Sandra Gagulic
Address 78976 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 78976 0
Portugal
Phone 78976 0
+351 232 910 107
Fax 78976 0
Email 78976 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.