ErgonomicsNCT03597802
Exercise at Workplace for Manual Material Handling Workers
A study testing Exercise at workplace - Three times per week and Exercise at workplace - Four times per week in people with Ergonomics and Manual Material Handling, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
This study aim to evaluate the effectiveness of exercise at workplace for manual material handling workers. This is a randomized control trial study by cluster with three parallel groups (n=200). Participants will be randomized in three groups: (1) control group - will be receive ergonomics orientation . Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ergonomics, Manual Material Handling, Occupational Health
- What is being tested?
- Exercise at workplace - Three times per week and Exercise at workplace - Four times per week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jul 2018to 17 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.
Who cannot join
- The exclusion criterial were sick leave
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rosimeire Simprini Padula
São Paulo, 12942770
Rosimeire S Padula, +55 11999166215, rosipadula@gmail.com
About this study
Official title: Effectiveness of Exercise at Workplace for Manual Material Handling Workers
This study aim to evaluate the effectiveness of exercise at workplace for manual material handling workers. This is a randomized control trial study by cluster with three parallel groups (n=200). Participants will be randomized in three groups: (1) control group - will be receive ergonomics orientation . (2) Intervention group - exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - exercise at workplace three times per week, during 15 minutes.Outcomes: The outcome measure will be verified in three moments at baseline, in six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, physical activity level.
Read the detailed description
Objective: This study aim to evaluate the effectiveness of exercise at workplace for control and prevention nonspecific low back pain. Methods: This is a randomized control trial study by cluster with three parallel groups. The context of this study is a motorcycle parts company importer localized in several states (Piaui, Ceará e Maranhão). The company has 575 workers, being 240 manual material handling. All are men over 18 years old that perform goods shipment (each work develop one this tasks - stock, separation, conference and packaging).
The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form. The exclusion criterial were sick leave. The workers will be included with low back pain or no low back pain (at baseline). All will be interviewed to obtain: weight, height, BMI, age, marital status, educational level, and actual function (stock, separation, conference and packaging sick leave (the last 12 months), musculoskeletal complains, medications, complementary exams, surgery and or fractures. Participants will be randomized in three groups: (1) control group - will be receive orientation about manual material handling, postural and low back care (lecture and guidance). The training will be instructions according Ergonomics standard (NR17) about transportation and load handling and exercise in workout. (2) Intervention group 1 - will receive the same instruction of the control group, and will perform exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - will be receive the same instruction of the control group, and will perform exercise at workplace three times per week, during 15 minutes. Outcomes: The outcome measure will be verified in three moments at baseline, six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, exercise workout.
Expected Results: The manual material handling workers will be better after intervention by exercise at workplace. The effectiveness of exercise for low back pain and no low back pain groups will be contribute to change the behavior in occupational context.
- Conditions
- Ergonomics, Manual Material Handling, Occupational Health
- Being tested
- Exercise at workplace - Three times per week, Exercise at workplace - Four times per week
- Keywords
- Ergonomics, Workplace, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise at workplace - Three times per weekOther
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
Exercise at workplace - Four times per weekOther
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance). |
| Intervention group 1 | Active comparator | The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance), and will perform exercise at workplace three times per week, during 15 minutes Receives: Other: Exercise at workplace - Four times per week |
| Intervention group 2 | Active comparator | The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance) and and will perform exercise at workplace four times per week, during 15 minutes. Receives: Other: Exercise at workplace - Three times per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pain Intensity at 6 months
Likert scale (0-10 points)
Measured: At baseline and after six months
Change from electromyographic signal at 6 months
RMS (root mean square error) signal and peak signal by Electromyographic (EMG)
Measured: At baseline and after six months
Secondary outcomes (3)
Change from palmar grip strength at 6 months
Three measure palmar grip strength to use the mean by dynamometer
Measured: At baseline and six months
Change from body mass index at 6 months
The body mass index will be calculated on height divided by square weight
Measured: At baseline and after six months
Change of behavior to exercise
Practice of exercise (practice - yes or no; number of times per week)
Measured: At baseline and after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start25 Jul 2018
- Primary completion19 Dec 2018
- Study completion17 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErgonomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597802
- Sponsor's protocol ID
- 2.372.435
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise at Workplace for Manual Material Handling Workers
- ClinicalTrials.gov ID
- NCT03597802
- Acronym / sponsor ID
- 2.372.435
- Conditions
- Ergonomics, Manual Material Handling, Occupational Health
- Keywords
- Ergonomics, Workplace, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 17 Dec 2020 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to evaluate the effectiveness of exercise at workplace for manual material handling workers. This is a randomized control trial study by cluster with three parallel groups (n=200). Participants will be randomized in three groups: (1) control group - will be receive ergonomics orientation . (2) Intervention group - exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - exercise at workplace three times per week, during 15 minutes.Outcomes: The outcome measure will be verified in three moments at baseline, in six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, physical activity level.
Detailed description
Objective: This study aim to evaluate the effectiveness of exercise at workplace for control and prevention nonspecific low back pain. Methods: This is a randomized control trial study by cluster with three parallel groups. The context of this study is a motorcycle parts company importer localized in several states (Piaui, Ceará e Maranhão). The company has 575 workers, being 240 manual material handling. All are men over 18 years old that perform goods shipment (each work develop one this tasks - stock, separation, conference and packaging).
The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form. The exclusion criterial were sick leave. The workers will be included with low back pain or no low back pain (at baseline). All will be interviewed to obtain: weight, height, BMI, age, marital status, educational level, and actual function (stock, separation, conference and packaging sick leave (the last 12 months), musculoskeletal complains, medications, complementary exams, surgery and or fractures. Participants will be randomized in three groups: (1) control group - will be receive orientation about manual material handling, postural and low back care (lecture and guidance). The training will be instructions according Ergonomics standard (NR17) about transportation and load handling and exercise in workout. (2) Intervention group 1 - will receive the same instruction of the control group, and will perform exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - will be receive the same instruction of the control group, and will perform exercise at workplace three times per week, during 15 minutes. Outcomes: The outcome measure will be verified in three moments at baseline, six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, exercise workout.
Expected Results: The manual material handling workers will be better after intervention by exercise at workplace. The effectiveness of exercise for low back pain and no low back pain groups will be contribute to change the behavior in occupational context.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance). |
| Intervention group 1 | Active comparator | Other: Exercise at workplace - Four times per weekThe workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance), and will perform exercise at workplace three times per week, during 15 minutes |
| Intervention group 2 | Active comparator | Other: Exercise at workplace - Three times per weekThe workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance) and and will perform exercise at workplace four times per week, during 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.
Key exclusion criteria (1 listed)
- The exclusion criterial were sick leave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise at workplace - Three times per weekThe exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load. | Other | Intervention group 2 |
| Exercise at workplace - Four times per weekThe exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load. | Other | Intervention group 1 |
Primary outcome
Change from Pain Intensity at 6 months
Time frame: At baseline and after six months
Likert scale (0-10 points)
Change from electromyographic signal at 6 months
Time frame: At baseline and after six months
RMS (root mean square error) signal and peak signal by Electromyographic (EMG)
3 secondary outcomes
Change from palmar grip strength at 6 months
Time frame: At baseline and six months
Change from body mass index at 6 months
Time frame: At baseline and after six months
Change of behavior to exercise
Time frame: At baseline and after six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise at workplace - Three times per week and Exercise at workplace - Four times per week in people with Ergonomics and Manual Material Handling, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Pain Intensity at 6 months (time frame: At baseline and after six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.