- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03597802
Exercise at Workplace for Manual Material Handling Workers
Effectiveness of Exercise at Workplace for Manual Material Handling Workers
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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São Paulo, Brésil, 12942770
- Recrutement
- Rosimeire Simprini Padula
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Contact:
- Rosimeire S Padula
- Numéro de téléphone: +55 11999166215
- E-mail: rosipadula@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune 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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Comparateur actif: 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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Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Pain Intensity at 6 months
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from palmar grip strength at 6 months
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2.372.435
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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