Resistance Exercise to Improve Fatigue in Workplace (REW) (REW)

April 16, 2019 updated by: Rosimeire Simprini Padula

Effectiveness of a Resistance Training Program in the Workplace to Muscle Fatigue Control in Industrial Workers: Cluster Randomized Controlled Trial.

Studies show that exercise resistance in workplace can reduce the symptoms of induced labor, however, the effectiveness of such programs depends on the characteristics of the training fatigue. Thus, it is expected that this study the intervention group with training heavy using progressive resistance exercise protocol will be better in reducing fatigue when compare with light training group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: This study is randomized clinical trial with double-blinded. The aim is evaluate the effectiveness the training heavy with resistance exercise program in the muscle fatigue control. Methods: This is a randomized controlled trial by cluster, in which workers who participate in the intervention group will perform resistance exercise protocols; and workers in the comparative group held only stretching exercises and light resistance training with elastic bands. Expected results: strong evidence that fatigue reducing after ten weeks in workers and improve in others outcomes. Not found in literature studies in occupational evaluating this aspect of training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
352

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Espirito Santo
      • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29303300
        • Centro Universitário São Camilo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sign informed consent

Exclusion Criteria:

  • restriction by the medical department.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Compensatory Workplace Exercise (CWE)
Comparative Group will receive a light training protocol including warming up, stretching and resisted exercise using elastic bands.
Other: Compensatory Workplace Exercise (CWE) - Comparative Group
The comparative group will receive warming up and stretching and light resisted exercise with elastic bands. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up for 5 minutes and 15 minutes of the specific training . The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
Experimental: Individual Resistance Exercise (IRE)
Intervention group will receive training protocol including warming up, stretching a specific resistance training with increase progressive load.
Other: Individual Resistance Exercise (IRE) - Intervention Group
Intervention group will receive warming up and stretching, and a specific resistance training with increase progress load. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up and stretching for 5 minutes and 15 minutes of the specific training. The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Need for Recovery
Time Frame: up to 4 months
Psychosocial risk factors and stress, resulting in work-induced fatigue, will be obtained by e Need for Recovery Scale (NFR).
up to 4 months
Fatigue
Time Frame: up to 4 months
1 RM test is the maximum amount of weight lifted once while performing a standardized exercise for muscle groups - elbow , knee and ankle flexors and extensors, trunk. A weight according to the maximum capacity is chosen. If a replay is completed, find the value of 1RM.
up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Musculoskeletal symptoms
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
Musculoskeletal symptoms (pain, tingling or numbness) will be assessed using the Nordic Questionnaire for Musculoskeletal.
Outcome measures will be assessed at baseline and after 4 months.
Level of physical activity
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
Questionnaire Baeck will be used to identify the level of habitual physical activity
Outcome measures will be assessed at baseline and after 4 months.
Perceived exposure
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
The perception of workers risk factors that may contribute to the development of musculoskeletal complaints will be evaluated through the Job Factors Questionnaire.
Outcome measures will be assessed at baseline and after 4 months.
Physical Fitness Assessment
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
The physical assessment will be consider adipometry (body fat percentage) others variables.
Outcome measures will be assessed at baseline and after 4 months.
Productivity
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
Productivity is measured by a single item General Health Questionnaire and Performance at Work
Outcome measures will be assessed at baseline and after 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rosimeire Simprini Padula

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rosimeire S Padula, Universidade Cidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 454.709

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