NCT03597802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

April 29, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

ErgonomicsWorkplaceExercise

Outcome Measures

Primary Outcomes (2)

  • Change from Pain Intensity at 6 months

    Likert scale (0-10 points)

    At baseline and after six months

  • 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 Outcomes (3)

  • Change from palmar grip strength at 6 months

    At baseline and six months

  • Change from body mass index at 6 months

    At baseline and after six months

  • Change of behavior to exercise

    At baseline and after six months

Study Arms (3)

Control Group

NO INTERVENTION

The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).

Intervention group 1

ACTIVE COMPARATOR

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

Other: Exercise at workplace - Four times per week

Intervention group 2

ACTIVE COMPARATOR

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.

Other: Exercise at workplace - Three times per week

Interventions

The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.

Intervention group 2

The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.

Intervention group 1

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIt is more common to be performed by men due to handled load
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosimeire Simprini Padula

São Paulo, 12942770, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2018

First Posted

July 24, 2018

Study Start

July 25, 2018

Primary Completion

December 19, 2018

Study Completion

December 17, 2020

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations