- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03597802
Exercise at Workplace for Manual Material Handling Workers
Effectiveness of Exercise at Workplace for Manual Material Handling Workers
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil, 12942770
- Recruiting
- Rosimeire Simprini Padula
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Contact:
- Rosimeire S Padula
- Phone Number: +55 11999166215
- Email: rosipadula@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.
Exclusion Criteria:
- The exclusion criterial were sick leave
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).
|
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Active Comparator: Intervention group 1
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
|
The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
|
Active Comparator: Intervention group 2
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.
|
The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Pain Intensity at 6 months
Time Frame: At baseline and after six months
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Likert scale (0-10 points)
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At baseline and after six months
|
Change from electromyographic signal at 6 months
Time Frame: At baseline and after six months
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RMS (root mean square error) signal and peak signal by Electromyographic (EMG)
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At baseline and after six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from palmar grip strength at 6 months
Time Frame: At baseline and six months
|
Three measure palmar grip strength to use the mean by dynamometer
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At baseline and six months
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Change from body mass index at 6 months
Time Frame: At baseline and after six months
|
The body mass index will be calculated on height divided by square weight
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At baseline and after six months
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Change of behavior to exercise
Time Frame: At baseline and after six months
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Practice of exercise (practice - yes or no; number of times per week)
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At baseline and after six months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2.372.435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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