- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172053
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
352
Phase
- 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
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Espirito Santo
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Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29303300
- Centro Universitário São Camilo
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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
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 |
Intervention / Treatment |
|---|---|
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Active Comparator: Compensatory Workplace Exercise (CWE)
Comparative Group will receive a light training protocol including warming up, stretching and resisted exercise using elastic bands.
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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.
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Experimental: Individual Resistance Exercise (IRE)
Intervention group will receive training protocol including warming up, stretching a specific resistance training with increase progressive load.
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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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for Recovery
Time Frame: up to 4 months
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Psychosocial risk factors and stress, resulting in work-induced fatigue, will be obtained by e Need for Recovery Scale (NFR).
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up to 4 months
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Fatigue
Time Frame: up to 4 months
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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.
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up to 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Musculoskeletal symptoms
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
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Musculoskeletal symptoms (pain, tingling or numbness) will be assessed using the Nordic Questionnaire for Musculoskeletal.
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Outcome measures will be assessed at baseline and after 4 months.
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Level of physical activity
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
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Questionnaire Baeck will be used to identify the level of habitual physical activity
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Outcome measures will be assessed at baseline and after 4 months.
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Perceived exposure
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
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The perception of workers risk factors that may contribute to the development of musculoskeletal complaints will be evaluated through the Job Factors Questionnaire.
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Outcome measures will be assessed at baseline and after 4 months.
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Physical Fitness Assessment
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
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The physical assessment will be consider adipometry (body fat percentage) others variables.
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Outcome measures will be assessed at baseline and after 4 months.
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Productivity
Time Frame: Outcome measures will be assessed at baseline and after 4 months.
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Productivity is measured by a single item General Health Questionnaire and Performance at Work
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Outcome measures will be assessed at baseline and after 4 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Santos HG, Chiavegato LD, Valentim DP, Padula RS. Effectiveness of a progressive resistance exercise program for industrial workers during breaks on perceived fatigue control: a cluster randomized controlled trial. BMC Public Health. 2020 Jun 3;20(1):849. doi: 10.1186/s12889-020-08994-x.
- Santos HG, Chiavegato LD, Valentim DP, da Silva PR, Padula RS. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial. BMC Public Health. 2016 Dec 22;16(1):1218. doi: 10.1186/s12889-016-3872-5.
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)
October 20, 2015
Primary Completion (Actual)
December 12, 2016
Study Completion (Actual)
March 3, 2017
Study Registration Dates
First Submitted
June 19, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 454.709
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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