Clinical trial NCT03597802: Exercise at Workplace for Manual Material Handling Workers
Official title: Effectiveness of Exercise at Workplace for Manual Material Handling Workers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ergonomics
Manual Material Handling
Occupational Health
Keywords: Ergonomics
Workplace
Exercise
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 . (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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Pain Intensity at 6 months
timeFrame: At baseline and after six months
measure: Change from electromyographic signal at 6 months
timeFrame: At baseline and after six months
Secondary outcomes:
measure: Change from palmar grip strength at 6 months
timeFrame: At baseline and six months
measure: Change from body mass index at 6 months
timeFrame: At baseline and after six months
measure: Change of behavior to exercise
timeFrame: At baseline and after six months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Rosimeire Simprini Padula
Study officials:
References: