ANZCTR - Registration

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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]

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)

Mental Health

low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Mental Health

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]

Prevention

Intervention code [2]

Rehabilitation

Intervention code [3]

Behaviour

Comparator / control treatment

Standard care (job rotation) is treated as a control

Control group

Active

Outcomes

Primary outcome [1]

pain perception in shoulder and low back.
Instruments algometry

Timepoint [1]

Baseline; Immediately post intervention and 12 weeks after intervention

Primary outcome [2]

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]

Baseline; Immediately post intervention and 12 weeks after intervention

Primary outcome [3]

flexibility in hamstrings and low back with sit and reach

Timepoint [3]

Baseline; Immediately post intervention and 12 weeks after intervention

Secondary outcome [1]

Outcome: psychosocial risks
Instrument: Copenhagen Psychosocial Questionnaire (COPSOQ)

Timepoint [1]

Baseline and Immediately post intervention

Secondary outcome [2]

cardiorespiratory fitness with 6-minute walk test

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Portugal

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Instituto Piaget Research in Education and Community Intervention (RECI)

Address [1]

Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comissão ética Instituto Piaget

Ethics committee address [1]

Av. João Paulo II - Lote 2º, 1990-157 Lisboa

Ethics committee country [1]

Portugal

Date submitted for ethics approval [1]

02/04/2018

Approval date [1]

20/04/2018

Ethics approval number [1]

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

A/Prof Sandra Gagulic

Address

Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu

Country

Portugal

Phone

+351 232 910 100

Fax

sandra.gagulic@viseu.ipiaget.pt

Contact person for public queries

Name

Sandra Gagulic

Address

Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu

Country

Portugal

Phone

+351 232 910 107

Fax

sandra.gagulic@viseu.ipiaget.pt

Contact person for scientific queries

Name

Sandra Gagulic

Address

Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu

Country

Portugal

Phone

+351 232 910 107

Fax

sandra.gagulic@viseu.ipiaget.pt

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.

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