- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03597802
Exercise at Workplace for Manual Material Handling Workers
Effectiveness of Exercise at Workplace for Manual Material Handling Workers
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo, 브라질, 12942770
- 모병
- Rosimeire Simprini Padula
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연락하다:
- Rosimeire S Padula
- 전화번호: +55 11999166215
- 이메일: rosipadula@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control Group
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).
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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Pain Intensity at 6 months
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from palmar grip strength at 6 months
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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