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- Klinische proef NCT03597802
Exercise at Workplace for Manual Material Handling Workers
Effectiveness of Exercise at Workplace for Manual Material Handling Workers
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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São Paulo, Brazilië, 12942770
- Werving
- Rosimeire Simprini Padula
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Contact:
- Rosimeire S Padula
- Telefoonnummer: +55 11999166215
- E-mail: rosipadula@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Control Group
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).
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Actieve vergelijker: 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
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The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
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Actieve vergelijker: 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.
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The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Pain Intensity at 6 months
Tijdsspanne: 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
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Change from electromyographic signal at 6 months
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from palmar grip strength at 6 months
Tijdsspanne: At baseline and six months
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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
Tijdsspanne: At baseline and after six months
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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
Tijdsspanne: 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
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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