Exercise at Workplace for Manual Material Handling Workers

Occupational Health Clinical Trial

Official title:

Effectiveness of Exercise at Workplace for Manual Material Handling Workers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03597802
• Other study ID #: 2.372.435
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: December 17, 2020

Study information

• Verified date: April 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 17, 2020
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ergonomics
• Manual Material Handling
• Occupational Health

Intervention

Other:
• Exercise at workplace - Three times per week
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
• Exercise at workplace - Four times per week
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.

Locations

Country	Name	City	State
Brazil	Rosimeire Simprini Padula	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Pain Intensity at 6 months	Likert scale (0-10 points)	At baseline and after six months
Primary	Change from electromyographic signal at 6 months	RMS (root mean square error) signal and peak signal by Electromyographic (EMG)	At baseline and after six months
Secondary	Change from palmar grip strength at 6 months	Three measure palmar grip strength to use the mean by dynamometer	At baseline and six months
Secondary	Change from body mass index at 6 months	The body mass index will be calculated on height divided by square weight	At baseline and after six months
Secondary	Change of behavior to exercise	Practice of exercise (practice - yes or no; number of times per week)	At baseline and after six months