FatigueREWNCT02172053
Resistance Exercise to Improve Fatigue in Workplace (REW)
A study testing Compensatory Workplace Exercise (CWE) - Comparative Group and Individual Resistance Exercise (IRE) - Intervention Group in people with Fatigue and Musculoskeletal Diseases, run by Rosimeire Simprini Padula at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Musculoskeletal Diseases
- What is being tested?
- Compensatory Workplace Exercise (CWE) - Comparative Group and Individual Resistance Exercise (IRE) - Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2015to 3 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sign informed consent
Who cannot join
- restriction by the medical department.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário São Camilo
Cachoeiro de Itapemirim, Espírito Santo, 29303300
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue, Musculoskeletal Diseases
- Being tested
- Compensatory Workplace Exercise (CWE) - Comparative Group, Individual Resistance Exercise (IRE) - Intervention Group
- Keywords
- Workplace, Industrial workers, Resistance exercise, Fatigue, Occupational risk, Physical therapy
- Medical subject headings
- Fatigue, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory Workplace Exercise (CWE) - Comparative GroupOther
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.
Individual Resistance Exercise (IRE) - Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Compensatory Workplace Exercise (CWE) | Active comparator | Comparative Group will receive a light training protocol including warming up, stretching and resisted exercise using elastic bands. Receives: Other: Compensatory Workplace Exercise (CWE) - Comparative Group |
| Individual Resistance Exercise (IRE) | Experimental | Intervention group will receive training protocol including warming up, stretching a specific resistance training with increase progressive load. Receives: Other: Individual Resistance Exercise (IRE) - Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Recovery
Psychosocial risk factors and stress, resulting in work-induced fatigue, will be obtained by e Need for Recovery Scale (NFR).
Measured: up to 4 months
Fatigue
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.
Measured: up to 4 months
Secondary outcomes (5)
Musculoskeletal symptoms
Musculoskeletal symptoms (pain, tingling or numbness) will be assessed using the Nordic Questionnaire for Musculoskeletal.
Measured: Outcome measures will be assessed at baseline and after 4 months.
Level of physical activity
Questionnaire Baeck will be used to identify the level of habitual physical activity
Measured: Outcome measures will be assessed at baseline and after 4 months.
Perceived exposure
The perception of workers risk factors that may contribute to the development of musculoskeletal complaints will be evaluated through the Job Factors Questionnaire.
Measured: Outcome measures will be assessed at baseline and after 4 months.
Physical Fitness Assessment
The physical assessment will be consider adipometry (body fat percentage) others variables.
Measured: Outcome measures will be assessed at baseline and after 4 months.
Productivity
Productivity is measured by a single item General Health Questionnaire and Performance at Work
Measured: Outcome measures will be assessed at baseline and after 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start20 Oct 2015
- Primary completion12 Dec 2016
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosimeire Simprini Padula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
- Investigators
- Rosimeire S Padula, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172053
- Sponsor's protocol ID
- 454.709
- Acronym
- REW
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2014
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32493267Santos 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.
PubMed 28003034
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Resistance Training Program in the Workplace to Muscle Fatigue Control in Industrial Workers: Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02172053
- Acronym / sponsor ID
- REW / 454.709
- Conditions
- Fatigue, Musculoskeletal Diseases
- Keywords
- Workplace, Industrial workers, Resistance exercise, Fatigue, Occupational risk, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Rosimeire Simprini PadulaUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensatory Workplace Exercise (CWE) | Active comparator | Other: Compensatory Workplace Exercise (CWE) - Comparative GroupComparative Group will receive a light training protocol including warming up, stretching and resisted exercise using elastic bands. |
| Individual Resistance Exercise (IRE) | Experimental | Other: Individual Resistance Exercise (IRE) - Intervention GroupIntervention group will receive training protocol including warming up, stretching a specific resistance training with increase progressive load. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sign informed consent
Key exclusion criteria (1 listed)
- restriction by the medical department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compensatory Workplace Exercise (CWE) - Comparative GroupThe 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. | Other | Compensatory Workplace Exercise (CWE) |
| Individual Resistance Exercise (IRE) - Intervention GroupIntervention 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. | Other | Individual Resistance Exercise (IRE) |
Primary outcome
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).
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.
5 secondary outcomes
Musculoskeletal symptoms
Time frame: 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.
Perceived exposure
Time frame: 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.
Productivity
Time frame: Outcome measures will be assessed at baseline and after 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 32493267Santos 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.
- Derived from this study: PubMed 28003034Santos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosimeire S Padula principal investigator
Universidade Cidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory Workplace Exercise (CWE) - Comparative Group and Individual Resistance Exercise (IRE) - Intervention Group in people with Fatigue and Musculoskeletal Diseases, run by Rosimeire Simprini Padula at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Recovery (time frame: up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02172053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019; AzTrials last refreshed its copy on 2 Nov 2026.